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The grass is still growing ever so slowly in the FDA’s injunction cases against U.S. and California Stem Cell Clinics

The grass is still growing ever so slowly in the FDA’s injunction cases against U.S. and California Stem Cell Clinics

Since my last update about these cases in early August, not much has happened, which is to be expected in federal civil litigation. Nonetheless, here is an update.

Let’s start with what hasn’t happened

1. There has been no announced agreement in either case that the defendants have stopped treating patients with their SVF, stem cell therapy which the FDA claims are unapproved new drugs, adulterated and misbranded, pending the final decision by the judges in these injunction actions.

2 The FDA hasn’t filed a motion for a preliminary injunction against either company to stop them from treating patients until the judges’ final rulings.

The FDA sure isn’t litigating these cases like these clinics are a big public threat. There are a few well-publicized cases of harm from U.S. Stem Cells patients, and there is much made of the fact that California group was using a dangerous toxic substance in processing their “drug” product. But as I’ve said in some previous posts, the FDA has bigger fish to fry.

See my post at:

http://www.rickjaffeesq.com/2018/08/01/update-on-the-fdas-stem-cell-injunction-cases”>http://www.rickjaffeesq.com/2018/08/01/update-on-the-fdas-stem-cell-injunction-cases”>http://www.rickjaffeesq.com/2018/08/01/update-on-the-fdas-stem-cell-injunction-cases

Of course, it’s a complicated subject for a federal judge, and maybe the FDA is worried about losing in the abbreviated hearing process of a preliminary injunction motion. Maybe the thinking is “do it right and take your time.” If so, I can’t argue with it.

Here is what has happened

U.S. Stem Cell

The defendants filed an answer in August. It largely parallel’s the answer in the California case, which isn’t surprising since the same big firm is lead counsel in both cases. Here is the Answer:

09261800

There is one big difference: U.S. Stem Cell’s answer contains a demand for “a jury trial as permitted by law.”

No such request was contained in the California Stem Cell Treatment answer. Getting the case away from a judge and into a jury’s hands would be a good thing for a defendant in this type of case, so did the California lawyers miss an opportunity?

I don’t think so. Injunction cases aren’t decided by juries; they are decided by judges. I think the Florida lawyers just tossed out a jury request and the docket just mechanically picked it up and the mechanical/automated software spit out the jury trial forms deadline. My guess and prediction is that down the road the jury trial issue will be addressed and rejected by the judge, even if the case gets that far.

The case is set for trial during a two week period starting June 10, 2019.

The more relevant deadline is March 11, 2019, which is the summary judgment motion deadline. Seems a safe bet that the FDA will file a summary judgement motion for a final judgment. (FYI: That’s how the Regenerative Sciences case was resolved). The feds will do some discovery, nail down via admissions and depositions what the company does and doesn’t do – most notably, being cGMP compliant – which establishes adulteration. The feds will get in admissible form the label instructions for use, which establishes misbranding, and obtain admissions and deposition testimony of the facts of how the product is processed, and how/for what indications it’s being used, which should establish non-compliance with the main regulatory requirements for drug status, i.e., more than minimal manipulation and non-homologous use, (at least under the FDA guidance documents.)

With those facts established in admissible form in discovery, there probably won’t be any factual issues to be tried by the judge (or jury). That makes the case amenable to resolution via summary judgement.

The defenses challenge is to find a disputed issue of fact on which the judge has to hear factual testimony from the parties at a trial. In this case, it will be a challenge, but there are some possibilities. The defense has smart lawyers and will figure it out, if there’s something to be figured out. And who knows, they might even come up with a legal basis to move the case sideways.

I’d look to have the defense seek a delay to filing papers in opposition to the summary judgment motion, figure a month. (Anything beyond that would probably interfere with the early June trial setting.) That would make a decision on the summary judgement motion in May. That’s how and when I’d see this case wrapping-up unless defense counsel figures out a way to derail or slow down the proceedings. Speaking as a defense lawyer, sometimes delay is the best you can hope for, because who knows what the future will bring. This point is aptly made in a fable I related at the beginning of my chapter on cancer doctor Stanislaw Burzynski’s several decades war with the FDA and the Texas medical board in Galileo’s Lawyer. It’s a good story. Here it is for those who have an immediate need for a smile.

mendal

Sometimes horses learn to fly, and a year or two could present an entirely new regulatory reality.

California Stem Cell

The parties filed a joint preliminary statement, which sets forth the claims and defenses, lists the witnesses, and the documents (and of course it can be amended as more information becomes available through discovery), and sets forth a proposed case schedule. The parties are looking at a trial in late July to early August, subject to the Court’s availability. They are proposing a motion deadline of late May. Here is the joint statement. castemcelljtdiscovery

There is a scheduling conference with the judge on Tuesday, October 1, 2018, at which point proposed deadlines will be adopted or changed.

The legal issues related in the joint statement are as expected and as discussed in prior posts, namely whether the defendants’ procedure is an unapproved new drug or not regulated by the FDA because it’s a same day surgical procedure, with not more than minimally manipulated autologous cells, given for a homologous use and all the practice of medicine and lack of jurisdiction stuff thrown in. The relevant trial documents are the 483 inspectional observations, communications between the parties and the final guidance documents pertaining to these issues, as well as patient complaints. Predictably, the defense seems to want to have some patients testify, and I’m always in favor of that. Look to the government to seek to stop that, because hey, that’s how they roll.

Yawn. I warned you it’s like watching grass grow.

Since the discovery process does not normally result in the publishing or making public, documents or other information revealed in discovery, I think nothing exciting is going to happen in these two cases (or nothing we will hear about) until summary judgement papers are filed (unless the lawyers come up with an interesting delay strategy). The Florida judge did refer the case out to mediation, but that’s a non-starter. U.S. Stem Cell isn’t stopping, and the FDA isn’t going away until it stops the Florida operation.

So any more news from the FDA in the stem cell field will be about other lawsuits or collateral things, like its cracking down on private stem cell clinics using clinicaltrials.gov to promote their clinics via patient funded clinical trials, per a recent post by the big dawg. https://ipscell.com/2018/09/fda-outlines-potential-crackdown-on-clinicaltrials-gov-offenders/

(And for the record, I don’t have a problem with the feds restricting clinicaltrials.gov to IND clinical trials, or at the very least, requiring disclosure that the trials are not FDA approved and that the “participants” pay for the treatment. That seems fair and reasonable.

I’m also very much in favor of the private stem cell clinics providing accurate and complete information about their operations, including that their treatments are not FDA approved, are not considered to be safe and effective by institutional authority, and that anecdotal evidence is not considered scientifically reliable, or even disclosing that there is no government review or verification that the statements made by the clinics on their web sites are true (like what the supplement manufacturers have to state). And I also don’t have a problem with the FDA or the FTC going after any health care facility which puts out materially false information to fraudulently induce patients to undergo the treatment. I’m all about providing the patients with accurate and complete information and let them make an informed choice, because it’s their bodies and their body parts we’re talking about).

So in sum about the status of the FDA’s two pending injunction cases: the millstones (wheels) of justice grind exceeding slow . . . . (you know the rest).

Rick Jaffe, Esq.
www.rickjaffe.com
rickjaffeesquire@gmail.com

For those who don’t: “The wheels of justice grind exceeding slow, but they grind exceedingly fine.” The odds favor the millstone over Mendal in these cases, so per Damon Runyon, “The fight isn’t always to the strong, or the race to the swift, but that’s the way to bet.”

RAJ

Some things in the private stem cell clinic debate are complicated, but some aren’t

Some things in the private stem cell clinic debate are complicated, but some aren’t

I am a believer and advocate that patients should have the freedom to use their own processed and expanded stem cells. That should mean that I support US Stem Cell Clinic’s fight against the FDA’s injunction action.

But I don’t.

I just can’t get past the fact that this Florida stem cell operation allowed a nurse practitioner to inject stem cells into several patients’ eyeballs which resulted in total or partial blindness. A nurse practitioner! Legal though it may have been under Florida law, it is an inexcusable lapse of judgement. Plus, the clinic had already settled several malpractice lawsuits and is facing at least one more lawsuit involving a patient.

I am an advocate for a patient’s right to use his/her own stem cells, but that doesn’t mean that a clinic which continues to cause serious harm to patients has the right to keep injuring them.

In my opinion, US Stem Cells has done serious and irreparable harm to patients, and it needs to be stopped now, not in next few years, which seems like the FDA’s current time table. I don’t often agree with the big dog (aka Paul Knoepfler) but on this issue, I do. See his post at https://twitter.com/pknoepfler.

How the Florida clinic can be stopped sooner rather than later

One of the stem cell luminary thought leaders, Bernie Siegel mentioned to me his hope that the latest big malpractice case against US Stem Cells might shut the place down. I told him I didn’t think so. Here’s why:

Malpractice claims are typically covered by malpractice insurance, and I have to believe given the clinic’s past experience, the first bill it pays after rent is its malpractice policy premium. It’s surely tough being sued, but when you’re not paying to defend and not paying the settlement amount, it’s not quite as tough, and is not a business ending event. So I don’t think any single or even a small number of malpractice lawsuits will do the job.

More effective would be fraud or deceptive practices lawsuits. These most likely won’t be insurance covered, at least not by malpractice insurance. I think there has been at least one such case filed against the clinic by a Miami law firm. I’m rooting for the plaintiff in that case. But these cases take time, and often times, the cases are settled. And insurance or not, I assume these Florida clinic folks have made a ton of money from their stem cell patient business, and they also have a training and franchise operation of sorts, so I wouldn’t expect even a fraud lawsuit or two to put them out of business, not in the short term at least.

So where does that leave those that want to see this clinic gone now?

We have to circle back to the FDA and think about what the agency would need to do to stop this clinic now(ish). And while some parts of the proposed plan may seem harsh, shocking and almost unbelievable, all these tactics have been used against me and my physician/clinic clients in the past by the FDA and other federal agencies.

1. Get the FDA’s OCI (Office of Criminal Investigations) involved

The FDA site inspection which resulted in a form 483 inspectional observations last year establishes what the clinic is doing. The statutes as interpreted by the final guidance documents establish probable cause that the FDA criminal trifecta has been violated (introducing into interstate commerce an unapproved new drug, misbranding and adulteration). The prior warning letter and the injunction complaint establish sufficient knowledge and intent to support a probable cause finding that the crimes are felonies. That should be enough for a federal magistrate to sign-off on a search warrant.

2. Execute the search warrant and take all the clinic’s patient records. If the clinic wants to see the medical records, it will have to come down the local FDA’s office and copy them.

3. Have the warrant search for non-FDA cleared medical devices or any other devices used in connection with the alleged criminal activity. (The latter is not a slam dunk.) That might/would stop the clinic from processing the fat into the stem cell SVF (stromal vascular fraction) product.

4. Invite the Florida medical board to participate in the raid. I don’t know whether the board has taken any action against the nurse practitioner and the supervising doctor yet, but if it hasn’t, there’s probably a decent case for an interim suspension proceeding against both. These proceedings are done ex parte, meaning it’s like a star chamber, done without telling the doctor in advance of the suspension.

5. Start interviewing the clinic’s patients. Many will be supportive of the clinic, including some who have received no benefit, but some won’t be.

6. Interview all the clinic’s employees and vendors/suppliers. OCI has some interesting interviewing techniques which in effect threaten criminal prosecution to people doing business with the target without technically threatening them, but the vendors get the message.

As I said, some or all of this might seem like legal thuggery, but me and my clients have been on the receiving end of all of them (Many of these tactics are discussed in chapters 2 and 9 in my book, Galileo’s Lawyer.). Combined, these tactics will get the clinic’s attention in a way which hasn’t heretofore happened. The other purpose of my discussing this is to show the FDA’s investigative tool box in cases where it really wants someone gone.

Other Government and private actors

US Stem Cells is a public company and that opens up another line of attack. The continued publicity already has and will continue to generate some interest by the SEC (Securities and Exchange Commission) which is looking into the company’s reporting documents (10K’s and 10Q’s). It’s probably a safe bet that the company’s disclosures were inadequate. With all the federal attention, some class action firm might file a shareholder’s suit, and that kind of suit burns a lot of cash for the public company.

The private lawyers who have filed civil malpractice or fraud lawsuits or are contemplating filing will be circling in the air waiting for any government action and especially any agency or judicial decision, which will make the civil fraud or SEC claims easier and faster to resolve favorably. To that end:

FINALLY

The FDA and the US Attorney’s Office should do what they should have done in the beginning, file a preliminary injunction motion, and request a hearing as soon as practical.

That’s going to present some interesting conundrums for the clinic’s principals. Do they testify? If they do, they can’t lie, or they’ll be charged with perjury. Can they say they didn’t know what they were doing is illegal? They can say it, but the judge doesn’t have to believe it. I doubt they’ve been told by an FDA attorney that what they’re doing is legal, so there won’t be an “advice of counsel” defense. Ultimately, they will either be forced to testify and most likely further incriminate themselves, or they’ll fold their tent and go away. (I’d bet on the former.)

If they don’t close down, then the final step is a criminal indictment, and that will put a whole new complexion on things. There’s a saying in criminal law. “You can beat the rap, but you can’t beat the ride.”

But in this case, once the blinded patients and the other injured patients testify, a preliminary injunction case, the permanent injunction case and a criminal trial are effectively over. No reasonable judge or jury is going to let these people continue.

And that’s why this is such a horrible case for stem cell advocates like myself. The idea that these people are the poster children for patients’ unfettered access to their own stem cells is disconcerting. That this case might set precedent for all same-day surgical procedure clinics should be distressing to all such clinic operators.

Therefore, best case scenario for both sides of the debate would be for the Florida clinic to voluntarily shut its doors now. Since that’s not going to happen, next best case scenario for everyone (including and especially patients) is that the clinic be shut down by the government as soon as possible.

And after that happens, the plaintiffs attorneys circling above will swoop down pick the clinic and its operators clean. If the clinic operators have an asset protection plan involving family members or family trusts, there will be fraudulent conveyance lawsuits.

Government and private action could trigger a voluntary bankruptcy proceeding by the corporate clinic/franchise entity. If so, the bankruptcy trustee will hire an attorney whose main job will be to claw-back all the money paid to the insiders, at least in the year prior to the filing, and probably longer. Ultimately, the lawyers (on both sides) will get it all.

That’s how I see it playing out if the FDA decides to take the case more seriously.

Of course, this is just my opinion and speculation based soley on publicly available information viewed through the lens of my 35 years working my side of the street.

What effect would all of the above have on the other private stem cell clinics?
Probably make them much more careful in what they do, say, and who they do it to. And even for a guy on my side of the street, that’s a good thing.

Post Script: I’ve recently read that these people have a new marketing idea and targeted audience: They’re doing penis stem cell injections.
Here we go again!

Rick Jaffe, Esq.
www.rickjaffe.com
rickjaffeesquire@gmail.com

Texas Medical Board to patients needing stem cells (and the Texas legislature): Drop Dead!

Texas Medical Board to patients needing stem cells (and the Texas legislature): Drop Dead!

Last year, the Texas legislature passed landmark stem cell legislation (HB 810). The law didn’t open the floodgates for every physician who wanted to inject patients with stem cells. However, it did allow patients to access their own stem cells (as well as other people’s stem cells), under controlled circumstances, namely the procedure had to be performed in a high level facility (an ambulatory surgical center or hospital), and it required university type IRB (institutional Review Board) approval.

Here is the Texas law:

https://capitol.texas.gov/tlodocs/85R/billtext/pdf/HB00810F.pdf#navpanes=0

As the bill was winding its way through the Texas legislature, a few Texas senators (probably doing the bidding of the Texas Medical Association and/or the Texas Medical Board (“TMB”) tried to kill the bill by adding requirement that the procedure had to be FDA approved, i.e., part of a clinical trial.
(I pointed this and other flaws in the bill in a post. See: http://wp.me/p7pwQD-a )
Let’s just say that my comments were not appreciated.

The whole point of the law was to allow people to receive stem cells even if they were not part of clinical trials or under FDA approved special exception. Obviously, by re-imposing the clinical trial/FDA approval requirement, the law would be meaningless. Fortunately, the clinical trial requirement was dropped from the final bill.

But………..

There was one other provision in the bill that was particularly worrisome to me: that the TMB was given carte blanc to promulgate rules implementing the stem cell statute.

I’ve been litigating cases before the TMB for 30 years and have interacted with dozens of board members. They are very conservative medically, and most don’t believe in physicians practicing beyond established clinical guidelines. So I was very concerned when the Texas legislature gave the TMB unfettered discretion to set-up rules for stem cells. I said so publicly, subtly in my past posts(see the end of this post, http://wp.me/p7pwQD-ab) and much more bluntly in private conversations with the patient advocates shepherding the bill through the legislature. Let’s just say my concerns were not well-received.

But my long (and hard-fought) experience with the board members and the Board’s legal staff was telling me that the Board was going to be very reluctant to implement the statute as the legislature intended. In fact, the relative ease in which the opposing Senators gave up the FDA clinical trial requirement made me suspect that they simply decided to pass the bill knowing that the Board would kill it, or at least never let it be implemented as the rest of the legislature intended.

So what’s in the Board rule?

On March 26, 2018, the TMB published its proposed rule on HB 810, the stem cell law as well as regulations implementing the Texas “right to try” law (I’ll deal with the right to try regulations in a separate post).

Here is a link to the entire revised rule on investigational treatments:
http://www.sos.state.tx.us/texreg/archive/April62018/Proposed%20Rules/22.EXAMINING%20BOARDS.html#30

Here is a pdf of just the stem cell part of the proposed rule.
SUBCHAPTER B

But it’s a statute and thus pretty boring, so I’ll just relate the part which kills the stem cell law:

“(d) Stem cell treatments which are under investigation in a clinical trial and being administered to human participants:
(1) may be administered or provided to eligible patients with qualifying terminal illnesses or severe chronic diseases as defined by the executive commissioner of the Health and Human Services Commission; and
(2) must be done in compliance with applicable law.
(e) In order for a patient to be eligible to receive treatment with investigational stem cells, the eligible patient must:
(1) be enrolled in a clinical trial investigating the use of adult stem cells in humans;”

As previously stated, the whole point of HB 810 was to make stem cells available to patients outside of clinical trials. There is no need for a law that says patients can enroll in clinical trials, because that’s already the law. The point is to allow clinicians not doing clinical trials to administer stem cells outside of clinical trials.

Well why can’t a clinician just start a clinic trial and administer stem cells to his/her patients?

The answer: because it’s illegal (or so says the FDA). Physicians can’t give non-FDA approved drugs (which the board rule calls “investigational drugs”) to patients except in an FDA approved clinical trial. If they do, they are violating the FDA’s trifecta of introducing an unapproved drug into interstate commerce, and providing a misbranded and adulterated drug to patients. That’s the thrust of the recent injunction actions that I wrote about in my last two posts. (And it’s a nonstarter for the average clinician to do a clinical trial; it’s a quantum level more work and money than any clinician or clinic can do (unless your name is Burzynski).

And remember, the TMB’s proposed rule states that the stem cells being administered to patients in clinical trials must be done so “in compliance with applicable law.” There’s no more applicable law than the FDA law and regulations on clinical trials.

I think there are other problems with the TMB rule regarding IRBs which will make compliance practically impossible for university level IRBs, but that’s secondary to the fact that the proposed TMB rule limits stem cell access to patients on clinical trials performed “in compliance with applicable law,” which was exactly the law before Texas legislature passed SB 810!

Way to go TMB! The stem cell Mafioso is breathing a sigh of relief.

The good news, if there’s any, is that that this is just the TMB’s proposed rule. Public comments are allowed. Here is the number for more information:
(512) 305-7016.

There might be a public hearing sometime in the future. To state the obvious, there’s more work to be done by the folks who are advocating for access to stem cells outside of clinical trials.

Rick Jaffe, Esq.
www.rickjaffe.com
rickjaffeesquire@gmail.com

FDA sends a Happy New Year greeting to another stem cell operation!

FDA sends a Happy New Year greeting to another stem cell operation!

As a prelude to more of what may be coming this year, the FDA has issued its first warning letter to a for-profit stem cell entity, on the third working day of the New Year. As per previous posts, expect more to follow in the coming weeks and months, targeting the most visible stem cell only entities.

Here is the warning letter:

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm591225.htm

Same ol, same ol, but with a twist

The letter is largely the FDA’s standard form warning letters to stem cell operations, but not quite. This entity, based in New Jersey, produces SVF (stromal vascular fractions) from adipose tissue, which is what most of these places do. That product is considered “more than minimally manipulated” under the FDA’s final guidance document. The business also apparently claims that its product may treat a wide variety of diseases, which makes the use “non-homologous,” under the aforesaid guidance document.

The letter also makes noises about a “biologics license.” Places like this New Jersey entity have more of a chance of seeing a unicorn than they do in obtaining a biological license.

And like two prior warning letters, this warning letter finds cGMP noncompliance, including not having a (very expensive) clean room, and well as numerous other facility, hardware, systems and documentation deficiencies involved in commercially producing drugs.

The rub/twist in this case

Based on the warning letter, it appears that this entity doesn’t actually treat patients, but rather just manufactures the product for resale/injection by health care providers.

The other rubs is that there is an IRB (Institutional Review Board) involved and, according to the warning letter, the product is listed “for research use only.” The FDA didn’t think either of these things helped the company’s case and made the product legal.

Just to recap the regulatory process

First, the FDA shows up for an inspections, usually unannounced and with at least three FDA inspectors. They stay for at least a week demanding to see documents. The last day of the inspection, the company is handed a 483 inspection report, which is the agency’s preliminary and non-binding and non-exhaustive findings/”observations.” (In these FDA stem cell inspections, I have to believe the agents have a standard form or template, since all of these entities have the same basic operation and operational deficiencies).

The company is given a short time to respond in writing to the noted 483 deficiencies. The FDA then reviews the response. The FDA is never satisfied with the response (at least in for- profit stem cell entities), so 3-6 months later, a warning letter arrives in the mail, usually after it is posted on the FDA warning letter web page
The company has another short period (15 working days) to respond to the warning letter. Most of the time, and especially if the entities respond without counsel, they just repeat their response to the 483 observations. The FDA then considers the response, and then . . . .?

What’s next?

This is the third warning letter issued against stem cell entities since late summer. (See my earlier post on the prior two warning letters:

http://rickjaffeesq.com/2017/09/22/sleeping-giant-awakens-fda-starts-final-push-eliminate-practice-medicine-stem-cell-clinics/

So far, the FDA hasn’t taken the next step which would be a civil injunction action to stop the stem cell providers for administering and manufacturing their products. But dollars to donuts, the civil actions are coming. I suspect they will be (or the two summer warning letter at least) will be filed about the same time, so as to maximize the PR/threat impact.

The FDA’s choice of the three initial targets is interesting and possibly informative

The Florida stem cell clinic involves the most egregious facts. A nurse practitioner injected stem cell products into patients’ eyeballs and caused permanent vision damage, and the operation is run by someone without any actual health care background or training. This should be an easy case for the FDA, on the merits and more importantly, it and won’t cause public outrage even from the pro stem cell clinic field because of the bad facts. As I’ve said before, this is the best initial target, from the FDA and stem cell Mafioso’s point to view.

The California clinic supposedly uses some illegal or non FDA approved toxin either in or in the processing of its HCT/P’s. That’s about as good as you can get from the FDA’s point of view in terms of trying to solidify the FDA’s position on “more than minimal manipulation.” It’s going to be very hard for a federal judge to go for the stem cell advocate’s view if a clinic is using dangerous toxins in its product.

The New Jersey case is interesting and useful to the FDA because it targets an HCT/P manufacturer. This an important part of the FDA strategy because there are many, many docs out there using HCT/P’s who are buying the product from manufacturers like this New Jersey company. With this warning letter, the FDA is telling all these manufacturers that it hasn’t forgotten about them.

We’ll have to see how it all shakes out, but I’m still predicting that multiple injunction actions will be filed by the FDA in 2018, and I’ll bet sooner rather than later.

I still feel that the defense is going to be part legal and part public/legislative, and there’s probably still some arguments to be made which might be more receptive to the courts than to the FDA, but we’ll see.

Rick Jaffe, Esq.
Rickjaffeesquire@gmail.com
www.rickjaffe.com

Landmark Texas Stem Cell Legislation Gets through the Texas Legislature!

Landmark Texas Stem Cell Legislation Gets through the Texas Legislature!

Over the Memorial Day weekend, the Texas Legislature passed amended HB 810, which allows access to autologous (yours) and allogenic (not your) stem cells. It is landmark legislation in that it is the first state law allowing access to stem cell treatments which are not FDA approved, and which do not fit within the narrow types of autologous stem cell treatments permissible under federal law.

Here is the amended bill awaiting the Governor’s signature. (The Governor has previously tweeted that he’s going to sign it)
ftp://ftp.legis.state.tx.us/bills/85R/billtext/html/house_bills/HB00800_HB00899/HB00810F.htm\

Bluntly speaking, the passage of HB 810 means that treatments which are illegal under federal law will be permitted, if given in Texas, at least under Texas state law.

That makes the Texas stem cell law analogous to the medical and recreational marijuana state laws, in that those state laws are in direct conflict with federal law. Another example of state laws in conflict with federal FDA law are the “right to try” laws which allow access to post phase 1 clinical trial drugs outside of FDA approved clinical trials, which is illegal under federal law.

Will the feds try to stop people from getting stem cells in Texas under the Texas law?

My guess is no for a variety of reasons. I don’t think the bill will open-up the floodgates to the kind of single doc small clinics based on the very severe limitations which the amended bill places of facilities and physicians seeking to do these treatments. For reasons which I’ll explain, you’re going to have to be big, well financed and well-connected to open-up a stem cell clinic in Texas which takes full advantage of the Texas law, meaning using cultured/expanded stem cells or umbilical or other allogenic (other people’s) stem cells.

The easy part of complying with the bill

To be eligible to receive stem cells under the bill, you’re going to need a certification from a physician that you have a terminal or chronic, incurable disease. That’s easy, since there are, regrettably, an overabundance of these types of conditions, anything from cancer, to MS, ALS and dozens more incurable diseases.

The patient is going to have to receive “informed consent” and maybe the Texas Medical Board will have a say in that, but that’s easy too. It’s experimental treatment, meaning that it hasn’t been proven by controlled clinical trials to be safe and effective. But these treatments are only going to be available for people with no other hope of cure, so informed consent won’t be much of an issue.

The Hard Part

The amended bill which came from the senate contained three onerous conditions. The first, which basically killed the whole bill, required that the treatments be in compliance with federal law. The whole point of the bill is to allow stem cell treatments not currently permissible under federal law, namely cultured/expanded autologous stems cells and umbilical cord and other types of allogenic stem cells. Fortunately, based on negotiations between the House and Senate, this provision was dropped, and that made the bill at least meaningful and possibly helpful to patients.

However, the House had to accept the other two Senate requirements to get the job done, and these limitations will mean that these type of stem cell treatments will probably only be available at a handful of places in Texas, at least for the foreseeable future. Here are the limitations on access to these treatments under the passed legislation:

1. Where you can get treated

The treatment will only be available at a hospital, medical school or ambulatory surgical center (“ASC”). In other words, you can’t get it at a regular physician’s office. Further, you can forget about getting these treatments at any medical school hospital because none of them (all of which do FDA approved research) are going allow the administration of non FDA approved drugs without FDA approval via the IND approval process (Investigational New Drug application). They get mega bucks from Pharma to do FDA clinical trials, and they’re not going to jeopardize that on so-called “unregulated human experimentation.”

The ASC (ambulatory surgical center) requirement was previously used by the Texas Legislature to eliminate or severely restrict abortions because individual physicians couldn’t afford to turn their offices into ASC level facilities. That might not be as much of a financial barrier in the stem cell arena since stem cell treatments are orders of magnitude more lucrative than abortions (hundreds of dollars versus 20k a pop for stem cells). Still, if a doc wants to provide these services, he/she will have to shell-out a few large, (as in millions) for up-front costs to create an ASC. That won’t be a problem for some of the popular off-shore stem cell clinics which had years to amass war chests awaiting their entry/reentry into the US market. Because of all the money in the field, ultimately, there will be players who will be able to either create ASC’s or partner-up with cash needy hospitals.

2. University or Big Hospital IRB Approval, Oversight and Paperwork Submission

The biggest impediment to unfettered access to unapproved stem cell treatments is that all stem cells under this bill must be given with IRB (Institutional Review Board) approval and oversight from a university/teaching hospital or large hospital IRB. As indicated, I don’t see any University IRBs granting IRB approval for the administration of non FDA approved drugs outside of clinical trials. But per previous, the lure of huge amounts of cash (and all these non FDA approved stem cell treatments are cash treatments) will induce at least some large but cash poor hospitals to try to set up an IRB and partner with or start their own HB 810 stem cell clinics.

The IRB requirement will stop every Tom, Doc and Harry from opening-up strip mall, doc-in-a-box facilities, and that’s probably not a bad thing. But it probably won’t stop the big off-shore or U.S, stem cell players.

Treatment will be expensive because the IRBs are going to have to maintain information about all patients treated and make annual submissions to the Texas Medical Board which takes time and money. The stem cell providers are going to have to give the hospitals and their IRBs their cut, while maintaining their substantial profit margins.

3. Texas Medical Board Approval of IRBs?

The bill allows the Texas Medical Board (TMB) to regulate the IRBs overseeing HB 810 stem cell clinics. I have a crystal ball and I’m getting a very clear picture that the TMB will decide to do so. Wait… I’m also seeing some language. Yes, I see the actual text of the TMB’s regulations of these IRBs. Here is what the TMB’s IRB regulations will look like:
In addition to being affiliated with a university or hospital per the bill, the IRB will also have to be accredited by the Association for the Accreditation Of Human Research Protection Programs, Inc. (AAHRPP) and be registered and qualified under the federal IRB statute (21 CFR part 56) dealing with human experimentation, or some other national accreditation organization recognized by the TMB.

Ok, my crystal ball isn’t that accurate, but I do know how to read the TMB’s current rules. The TMB already regulates IRBs overseeing the use of investigational agents, (Board Rule 198). What I’ve related above is what the TMB currently requires for IRBs supervising investigational agents. There is no reason to think that the Board will do anything other than apply this already existing board rule to stem cells.

4. Physician Compliance with Board Rules
The bill also states that a physician administering stem cell treatments must comply with all applicable medical board rules. That’s alittle vague for my taste. As an experienced Texas Board lawyer, it opens up all kinds of stumbling blocks and pitfalls. But we’ll leave that discussion for another day.

So here it is: Texas is poised to become the first state to allow the use of cultured/expanded stem cells, as well as umbilical and other allogenic tissue products outside of FDA approved clinical trials.

That is very good news for patients with terminal and incurable chronic diseases who chose to assume the risk of “unproven” treatment, (and I personally think this is a basic but heretofore unrecognized right). It’s bad news for the stem cell institutional Mafioso who wants to limit access to these treatment to FDA approved clinical trials.

The patient advocates (and the legislators) deserve a great deal of credit. They did an amazing and almost unbelievable job which will benefit many patients.

But my message to them is that it’s not over yet, even when the Governor signs the bill. The ball will go to the TMB’s court and there are many ways in which this can all go sideways.

So continued vigilance is the watchword.

Still, congrats on a job well done. Patients with incurable diseases owe you big-time.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Hey Mr. President: how about some quickie executive orders on prescription drug importing, stem cells, and vaccination

Hey Mr. President: how about some quickie executive orders on prescription drug importing, stem cells, and vaccination

Mr. President: looks like you’ve kept your word so far on Obamacare by signing a vague executive order allowing federal government agencies to do what they can to lower the costs or make more efficient whatever the agencies can figure out they can do without congressional approval. Hopefully that will work out.

I have a couple of ideas for some quickie executive orders, consistent with your campaign speeches or your thinking. As always, I’ll keep it short:

1. Consumers importing cheaper prescription drugs

Congress took up the issue, and since both parties are in the Pharma’s pocket, it once again declined the chance to help people by allowing them to import prescription drugs from Canada and other places where Pharma sells its products for a lot less money. You recently took Pharma to the woodshed in a recent tweet. On behalf of the people, thanks. In your inauguration speech, you railed against Congress for not watching out for us. Here’s my suggestions:

First: we need a standard Trumpian tweet excoriating Congress for protecting Pharma by its recent action in continuing the prohibition of patients from importing drugs manufactured by major drug companies which are sold for a lot less money abroad.

Second: how about an executive order ordering the FDA, DOJ and Customs not to enforce the existing drug importation restrictions. That would send a message to Pharma and Congress, as well as immediately save patients money.

Yes, you and the rest of the Republicans hassled Obama for using executive orders to circumvent enforcement of existing federal laws like immigration.

But let’s get real. That’s just an argument used by the party that doesn’t control the presidency. Further, I don’t think we should worry about little things like consistency. I’m guessing you’re okay with that, especially if some minor inconsistency can benefit the people who supported you, and trust me, your working class supporters will really appreciate having the option of cutting their out-of-pocket drug costs by half or more. You do this, and I guaranty your approval rating will jump-up a few points.

2. Stem Cells

Don, first thing I’d like you to do is call Rick Perry, and ask him about his experience in getting a stem cell transplant for his back problems. FYI, his stem cell procedure was flat-out illegal under federal law. But he was the Governor, so who was going to stop him? I’ve heard it helped him alot. If so, why shouldn’t the tens of thousands of patients who could similarly benefit from stem cell treatments get them? Do you really have to be a Governor to get the state-of-the-art treatment?

I’ve covered the FDA’s regulations and the technicalities in numerous prior posts,
http://rickjaffeesq.com/category/stemcells/

But the bottom line is that your FDA severely limits access to stem cell treatments, and you should do something about it immediately, even before the FDA Commissioner is identified or sworn-in. So here’s what I suggest:

First: A quickie executive order that whatever draft guidance documents concerning stem cells (and there are currently four, explained in prior posts, see above) are on hold, and no final guidance documents will be issued except on the approval of your FDA Commissioner.

Second: Another executive order that as matter of enforcement policy, neither the FDA nor the Department of Justice will take any action against a clinic which removes stem cells or any other human tissue from a person, and reinjects or reimplants that tissue into that person. And the enforcement policy should make clear that it applies even when the stem cells are other materials are expanded or cultured, which is the procedure which was so successful on Rick Perry. If Rick Perry could do it, let the rest of us have access to this stuff. (And BTW, there is less of or no consistency problem here since the regulations actually allow many stem cell treatments; it’s just the FDA has decided in its infinite unwisdom to try to stop almost all of these procedures.). The institutional stem cell players and the aforedescribed media cheerleaders won’t like it, but your supporters and many, many others will love you for it.

3. Vaccination

First: Let’s get moving on the Bobby Kennedy Jr. Vaccine/Autism thing. Maybe this could be done by executive order as well. Hell, it’s just a commission. I know you received some pushback from the institutional vaccine pushers and their cheerleaders in the media, but there is a groundswell of support for Bobby and the Commission from the people, and per your speech yesterday, that’s what important to you.

Second: as you probably know, federal agencies have some kind of internal oversight, referred to as the “OIG” (Office of Inspector General). In light of some of the recent stories about cover-ups and scientific fraud at the CDC concerning the autism issue, you need to give some serious consideration to the CDC OIG position. Your pick needs to be willing to take on the powers that be in the agency. So choose wisely.

Enjoy the job, and hope you really shake things up in the health care field. It’s long overdue!

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Dear Donald: Good move on Dr. Tom Price at HHS and Jim O’Neill at the FDA

Dear Donald: Good move on Dr. Tom Price at HHS and Jim O’Neill at the FDA

Dear Donald:
Good move on Dr. Tom Price at HHS and Jim O’Neill at the FDA. Both seem to be disruptor/game changers, which is exactly what HHS and FDA need. As a guy who has been battling the FDA for a few years and per your request, here are a couple things which they should do from the get-go, without alot of bureaucratic red tape. Let’s start with getting the FDA bureaucrats off the backs of patients and consumers.

Stem Cells:
You’re not going to believe this, but according to the FDA’s current thinking, patients need the FDA’s permission to use their own stem cells for most medical conditions. Really. That’s crazy isn’t it? There are about 600 clinics here which are giving stem cells to patients, but they will have to shut down if the FDA gets its way. Here are two things which Jim should do immediately:

First: withdraw the FDA’s four pending draft guidance documents which impose some of these crazy restrictions on peoples’ rights. (I’ve talked about this in some of my past blogs in case your people want the details.).

Second: Jim should issue a new policy statement that the use of your own stem cells, tissue or body parts (what the FDA calls “autologous use”) is not regulated by the FDA because it’s the practice of medicine which is governed by state law. That would also include the expansion or culturing of your own stem cells. The one sentence response to hand-wringers about patient safety: the state medical boards are in a better position to oversee doctors who treat patients with their patients’ own body parts.

Dietary Supplements:
My guess is that you’re not into nutritional supplements, but tens of millions of Americans are and they spend upwards of 40 billion dollars a year on them. We have the freedom to purchase supplements with minimal FDA oversight. Basically, manufacturers can’t say supplements can cure diseases or medical conditions. The FDA is trying to change that with another of its “draft guidance documents” on what it calls “new dietary ingredients.” Under the FDA new position, it’s going to be very hard for consumers to buy supplements. So Jim needs to withdraw the pending draft guidance document on “new dietary ingredients.”

I also think manufacturers ought to be able to tell consumers about the research supporting their products, but Jim and I can talk about that later, and he’ll fill you in.

Drugs and Pharma:
Dealing with drugs is more complicated. Because of how busy you are, you might not have picked-up that Congress just passed a law which will streamline the FDA approval process, (supposedly), by allowing the FDA to consider real world results rather than just formal clinical trials, and accepting data from foreign clinical trials (and a bunch of other stuff, but no need to get into the weeds).

This should save Pharma big money in future drug testing, so let’s get something back, since Pharma’s been raping American for years with excessive drug prices (which by the way, it doesn’t do when it sells its drugs in the rest of the world).
You’re 100% right to tell Pharma it has to lower the cost of drugs. For sure, let government agencies negotiate lower drug prices. That will save the government a few hundred billion over time. You’ll have to fight both parties since they’re both in Pharma’s pocket. (It was Congress which gave up the government’s right to negotiate bulk discounts.) But you can fix that. Seems like twitter is the way to go. Just have your followers email the Republican leaders for a bit and that should do it. And no one will complain about your going after congressional leaders on twitter. Your supporters will love it!

Next, a money making idea. I’m going to tell you something which as a businessman you’re not going to believe. The federal government via the NIH actually invents many of the novel drugs which Pharma sells. Guess how much the government receives for the drugs which it discovers?

NADA! Really. The government gives away these drugs, even the ones that eventually becomes blockbuster multibillion dollar revenue producers. Nuts isn’t it. So let’s get our piece from the back end. A couple billion here and there eventually adds up.

Vaccines

I don’t know whether it was real or fake news that you met with Andy Wakefield, but I do hear you have some concerns about vaccines. I do too. I’m working on what may be the most important vaccine case in the country now. It involves a doc who thought a child shouldn’t get any more vaccines after having two very bad adverse reactions. The medical board is going after him. One thing I’ve discovered is that that many physicians are afraid to come forward for fear of professional retailiation from the pro-vaccine scientific Mafia. You might know there are two big scandels involving the CDC, phony safety and non causation data issues. This needs to be looked into.

My Suggestion: Tom needs to get some folks to figure out whether vaccines are causing some diseases like autism, which is what the anti-vaxxers claim. It shouldn’t be a CDC operation since those folks may be part of the problem and may even involved in a cover-up. Nor should the muckimucks at the establishment pediatrician groups be involved (other than as witnesses or targets) since many of them have serious conflicts; they take money from vaccine manufacturers or are vaccine inventors.

Ok, this is just off the top of my head, but doing the above would be a very good start. I’ve got a couple thoughts about replacing Obamacare. I’ll send you something after Saturday Night Live.

And by the way, I’d like to serve, so I’d appreciate it if you could put in a good word about me to Arnold. I hear you’re still involved.

Regards, and best of luck with the new gig.

Rick Jaffe, Esq.

THE SCARIEST ATTACK ON PERSONAL FREEDOM YOU’VE NEVER HEARD OF/ THE BIG TAKEWAY: If the FDA gets its way, the most popular post mastectomy breast reconstruction procedure will become illegal, and so will many other life enhancing procedures

THE SCARIEST ATTACK ON PERSONAL FREEDOM YOU’VE NEVER HEARD OF/ THE BIG TAKEWAY: If the FDA gets its way, the most popular post mastectomy breast reconstruction procedure will become illegal, and so will many other life enhancing procedures

Using your own stem cells, tissue and body parts without FDA interference should be a no brainer and a slam dunk, but it isn’t. I mean it’s your own body. How can the federal government interfere with your privacy and autonomy right to use parts of your own body as a treatment? The short answer is they can and if the FDA gets its way, future patients are not going to be able to use their own cells and tissue as tens or hundreds of thousands of patients, including breast reconstruction patients, have been doing for years.  Here is how the FDA is going to stop you from using your own stuff (stem cells and tissue like fat, or what the FDA calls “Human Cells, Tissues and Cellular and Tissue-Based Products” or “HCT/P’s as the federales call it.) But first some short regulatory history

How the FDA thinks of your body parts

Until the 1990’s, removing and reinserting body parts wasn’t regulated by the FDA, other than making sure that it was collected and maintained in a safe and sterile way. But then stem cells started to become a popular research field, and all the hype started about the magical therapeutic power or potential of stem cells. So in the late 1990’s the FDA started making noises about regulating stem cells and other human tissue. That would include both your own stems cells (called in medical and regulatory parlance “autologous”, and someone else’s stem cells or tissue (“allogenic”).

In 2005, the FDA published its final rules concerning HCT/P’s.  (Here is the link to 21 CFR 1271, for the legally curious.  (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271)

The regulations created three different regulatory pathways for HCT/P’s; some were considered “new drugs” which required full FDA approval, which is a hideously expensive and unreasonably long endeavor. (This is sometimes referred to as the 351 pathway); some just required that the facility using the stem cells or other tissue register with the FDA (sometimes referred to as the 361 pathway), and if the stem cells or other tissue was removed and reinserted into the person in the “same surgical procedure,” the FDA didn’t regulate it at all because it was the practice of medicine which supposedly the FDA doesn’t regulate.

The FDA’s 2005 regulations introduced two biologic/analytical binary concepts which it uses as criteria for determining which of the three regulatory pathways applied to a particular use of an HCT/P: Homologous vs. non homologous and minimally manipulated vs. more than minimally manipulated.

To oversimply, a use of an HCT/P is homologous if the use of the material in the donor location is the same as in the recipient location. When the FDA regulations were first put out in 2005, there was some vagueness or flexibility in what constituted the same or homologous use.  The regulations stipulated that if the use was homologous, the use might only require registration under the 361 regulatory pathway (and if a number of other requirements were met). But if the HCT/P use was non-homologous (meaning that the use the cell had in the donor location was different from the intended use in the recipient location), then regulatory magic turned your HCT/P into a 351 new drug with the aforementioned hideously expensive and unreasonably long consequences. Seems crazy, but that was the reg.

Now you usually can’t just take stem cells out of your body; they have to be separated from fat, bone marrow, or blood. That means after you take out the material, the stem cells or other material is separated, using either a chemical agent or a mechanical process (like a centrifuge). Usually there is also other processing needed before the material is reimplanted.

The processing of the material gave rise to the second binary concept, minimal manipulation vs. more than minimal manipulation of the HCT/P.  If the cells are not more than minimally manipulated, the procedure could be done with just 361 facility registration (assuming homologous use and several other technical requirements set out in the 1271.1 (Here’s the link to the regulation if you’re turned-on by that kind of thing.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.10 )

But if the cells were more than minimally manipulated, then you are thrown back to the new drug path. Remember, we’re talking about your own stuff. Under the rule, there was some ambiguity as to what was or wasn’t minimal manipulation. Back when the rules first became effective, I had a client who wanted to take out fat, separate the mesenchymal stem cells and reinsert the cells back. To me, it seemed legal under the rules. I called the FDA a couple times to make sure I was right, and everyone at the agency I talked to agreed. But that was then.

Since that time, there has been an explosion of stem cell clinics taking fat from people and reinjecting the stem cells. Worse from the FDA’s point of view, many of these clinics were making all kinds of miraculous cure claims. Problem was there was no proof that the claims were true for most of the diseases or problems claimed to be cured or helped by stem cells. That made the FDA unhappy, which is bad thing. (Trust me, I know how bad it is when the FDA gets unhappy).

Long story short: the FDA decided to clamp down on all of these clinics, and used two of its most effective tactics.

First, it sent cease and desist letters (what the FDA calls a “warning letter”) to a couple of the most visible offenders. (Hit the big guys first to scare-off everyone else). The FDA publishes all warnings letters, and that got the industry’s attention.

Second, in the last year or two, the FDA issued four draft guidance documents “clarifying” the meaning the two key terms homologous/non homologous use and more than minimally manipulated (or not). But the FDA didn’t just clarify these terms; it rewrote the rule to knock-out some of the most popular and effective medical procedures, perhaps most importantly, the most popular post mastectomy breast reconstruction procedure with flap surgery.

No point getting too much in the weeds of how the feds did it (see my last post if the legal weeds is your thing.

http://rickjaffeesq.com/2016/09/13/fda-draft-stem-cell-guidance-documents-exposed-improper-rulemaking-bad-science-heartless-public-policy/

But here is the most egregious example that shows the abject stupidity of what the FDA is trying to do:

Flap reconstructive breast surgery takes fat (usually belly fat) and builds up the breast. Under the guidance documents, the main function of fat is structural. The main function of a breast (in a woman) is lactation.  (Some presenters of the female persuasion who presented at the stem cell public hearing were really annoyed about that characterization).  Lactation is a different function than the function of belly fat (structural). Therefore the use the flap procedure is non-homologous, which means the use has to obtain full FDA approval before it can be used outside of FDA approved clinical trials. Many of the presenters used this as an example of why the draft guidelines are wrong. (more details in my last post: http://rickjaffeesq.com/2016/09/13/fda-draft-stem-c…ss-public-policy/ ‎)

The fact that tens of thousands of women have had this procedure and are walking around feeling better about themselves is irrelevant to the FDA.

I’d like to meet the idiot who came up with this. Better still, I’d like to put him/her/them in a room with a few mastectomy patients who need the flap surgery, and let them explain to the patients why their belly fat and breasts are any of the FDA’s business.

Remember when I said that the FDA told me that docs can take fat out, separate the stem cells and reimplant them without FDA oversight if it was done during the same surgical procedure? Well that’s out the window now. Under the guidance documents, separating the stem cells from the fat constitutes “more than minimal manipulation” of the HCT/P and requires full-on FDA approval because your stem cells are now an unapproved drug and they can’t be reinjected into you without being approved by the FDA.

I get that the FDA is concerned about clinics making unsubstantiated claims. There are also a few well-publicized incidents of harm, most notably some clinic which apparently let a nurse practitioner inject stem cells in the eyeballs of patients. What idiot decided that was a good idea? Still, the remedy to that kind of problem is or could be a combination of civil actions by the patients, criminal prosecution, professional licensure proceedings, or state action to shut the place down. As to claims, The FTC has jurisdiction to deal with false claims issue, as does the state under state consumer deceptive trade practice laws.

The point is that there are a lot of options for dealing with places which do crazy things, harm patients, or make outrageous claims. The solution shouldn’t be that FDA closes down the entire autologous transplant industry because of some exceptional bad examples. Describing this as overkill is an understatement.

So here’s what needs to be done. The FDA has to rescind the draft guidance documents and start over. In the interim, the FDA should get the hell away from my stem cells and other body parts and yours too, at least if we want to take them out and put them back in our own bodies.

What can you do about it? Plenty

The public hearing of the FDA’s stem cell guidance documents ended last Tuesday, September 13, 2016, but the public comment period is open until September 27th.

If you think you might ever need to use your own stem cells or other body parts in the future, or if you know anyone how might need them, or if you think that what the FDA is doing is a bad idea, then write, fax or email the FDA and tell them. Here are some possible points:

  1. Withdraw the four HCT/P guidance documents
  2. Get out of the business of regulating a person’s use of his own body parts
  3. Any opinions  you might have about where they should place their draft guidance documents, or such other opinions you might have on this regulatory exercise, mindful of the rules of polite discourse, based on your discretion and/or temperament.

Maybe if a few hundred thousand people contact these jokers, they might get the message.

 

Where to send your comment?

Here is the information I found about sending comments:

“Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions: All submissions received must include the Docket No. FDA-2015-D-3719 for “Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Rescheduling of Public Hearing; Request for Comments.”

If you want to go the email route: do one or both:

CBERPublicEvents@fda.hhs.gov

Or go to Federal eRulemaking Portal:  http://www.regulations.gov.

FYI: here is the sub heading from the eRulemaking Portal:

Make a difference. Submit your comments and let your voice be heard.

That’s good advice.

Here is the FDA Federal Register Notice about the Hearings, where you can read the written comments, and more details on submission of comments.

http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/UCM497048.pdf

If you want more details about the issue or love the weeds, here is a link to all my recent posts on this topic. They’re in reverse chronological order, so start with the last one “Are stem cells over?”

http://rickjaffeesq.com/category/stemcells/

 

Tally ho!

 

Rick Jaffe

www.rickjaffe.com

 

(To Clinton Miller, I hope we can do you proud.)

 

 

How many cosmeceuticals can fit on the head of a pin?

How many cosmeceuticals can fit on the head of a pin?

    How many cosmeceuticals can fit on the head of a pin?

None, according to the FDA, because there is no such thing.  In FDA-land, there are only regular cosmetics which are essentially un-FDA regulated, and cosmetics which are drugs and regulated as drugs, meaning full-on FDA new drug approval applications.

My guess is that the term “cosmeceuticals” was created from an analogy to nutraceuticals which are dietary supplements which have some structure/function type of medical application or value. Nutraceuticals is a thing because DSHEA allows structure/function claims. Cosmeceuticals don’t exist (from a regulatory point of view) because there are no permissible structure/function claims for cosmetics. (More about this later.) So in a way, a cosmeceutical manufacturer is someone who is manufacturing an illegal product, but hasn’t been stopped by the FDA yet. That is the theory anyway.

In truth, I’ve always had some reluctance to dive into the FDA cosmetic legal arena because of what I thought was a regulatory disconnect between the law and FDA enforcement actions. But that has changed in the last year or two. Now the FDA is more aggressive in going after manufacturers/promoters of cosmetics who make drug/disease/structure function claims. In the last eighteen months or so, it has sent at least a half dozen warning letters to cosmetics companies making drug/disease/prevention/structure function claims. Warning letters are sent to specific companies, but they also are one of the FDA’s main tools for ensuring compliance with the law amongst the industry as a whole.

Two definitions

What are cosmetics?

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)].

Stuff like skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product would all be considered cosmetics.

The problem area to me is the “altering appearance” thing. I don’t think the FDA gives it a very broad meaning, as some examples from warning letters will show.

What’s a Drug?

The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].

A product which makes a structure/function claim is a drug, unless it is a dietary supplement (i.e. ingested as a dietary aid) in which case a structure/function claim is permissible because of an exception to the drug definition contained in DSHEA (the 1994 dietary supplement act).

The important take away is that there is no parallel exception for cosmetics (or medical devices). Therefore, based on the functional definition of a drug, if you are a manufacturer of a cosmetic and make a disease/treatment/prevention of disease, or a structure/function claim, under FDA law, you’ve got a cosmetic which is also regulated as a drug. If you don’t have an NDA, you are manufacturing an adulterated, misbranded drug which you are illegally introducing into interstate commerce (or what I call the FDA trifecta, which by the way carries civil and criminal penalties).

What kinds of claims gets cosmetics manufacturers in trouble?

Here are a few claims culled from some warning letters: “removes wrinkles instantly, Ideal for treating, sun spots, age spots, acne scarring, hyperpigmentation, supports the synthesis of new skin fibers, soothes and reduces redness and irritation, strengthen the skin’s ability to repair and protect itself.”

You can’t circumvent the law by attaching the claim to an ingredient rather than the whole product. For example the FDA has put the kybosh on claims that an ingredient “works in a similar way to Botox, increases cell communication and gene activation for the skin healing, thus it plays a fundamental role in the reconstruction of the skin tissue, is very high in lignans that support cell communication.”   So cell communication language seems problematical to the FDA. The FDA even took offense with a claim that an ingredient “helps increase skin hydration by inhibiting hyalurondase.”

Want to increase your odds of getting an FDA warning/cease and desist letter? Use “stem cells” in your product name or advertisements, and then talk about their healing and regenerative powers. The FDA is coming down very hard on stem cell clinics because of false advertising and drug claims, and it has recently issued several stem cell guidance documents, the gist of which is that stem cells are considered drugs.  So to the FDA, using “stem cells” in a name or advertisement for a cosmetic is like putting a sign on your door, web site and forehead that you are manufacturing an unapproved new drug which is misbranded and adulterated.

What about Docs who make disease/prevention/structure/function claims for cosmetics?

The good news: The FDA doesn’t normally involve itself with practicing physicians. So unless a doc is selling cosmetics over the internet, the FDA is unlikely to take issue with the promotion.

The bad news:  In the last few years, the state professional boards have given greater scrutiny to advertising by health care professionals for false or unsubstantiated product claims. Basically, whatever a manufacturer couldn’t or shouldn’t say under federal FDA law, usually can’t or shoudn’t be said by a health care provider under state board law. There might be exceptions and extenuating circumstances, but you shouldn’t get into to trouble by following the federal law.

So a guy jumps off a hundred story building. As he’s passing the 50th floor, he’s asked how he’s doing. “So far so good.”

Be careful!

Rick Jaffe

rickjaffeesquire@gmail.com