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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