APC Town Hall Recap

I feel a renewed sense of urgency and ambition toward providing good information for folks to choose a reputable provider after this well-rounded zoom with the APC.

A recording of the presentation will be available on Friday 6/28/24. I will link it here.

Represented by Scott Brunner, CEO, and Tenille Davis, Chief Advocacy Officer, as well as a team of attorneys, the APC laid out their responses to media claims, lawsuits, even doctors making arguable statements publicly. They addressed the statements made by the Obesity Association. They discussed FDA syntax and legality in detail.

The big takeaway, in my mind, is that there is an aggression toward the pharmacy compound world since the announcement by the FDA of semaglutide and tirzepatide being listed "currently in shortage". They made an important point that is being discussed in courtrooms, the term "currently is shortage" is enough for the drug to be considered no longer commercially available, which I had known from reading FDA docs 6 months ago but it is nice to hear it spoken is such plain terms. The FDA website has an option to click-thru to a list of doses with some listed in shortage, others are not. That is irrelevant. The initial page where the drug is listed in shortage is enough.

That is what mobilizes compounding pharmacies to produce the drug with the nod of the FDA. Of course, uncounted sums went into the production of these drugs.

(I'll interject here: The FDA has a precarious balance between the obligation to ensure the nation has uninterrupted access to a life-changing drug, while not threatening the future development of new drugs by kneecapping the profits gained from the investments made in development. In other words, they don't want future breakthrough drugs to not exist because investors saw it as a questionable opportunity, citing this situation as a reason to back out. That doesn't change the fact that people need these meds now, urgently, for more than just vanity reasons. Those are my own words. Back to the summary.)

There are hundreds of millions of prescriptions being dispensed for semaglutide and tirzepatide. They are being researched for applications including cardiovascular benefits, Alzheimer's treatments, etc. Compounding pharmacies also continue to dispense other important medications, such as custom cancer treatments. Should the image of the industry become tarnished enough by the onslaught of misinformation, there is real concern for the future of the compounding world as a result of the attention as a result of the GLP-1 shortage. It is more important than ever that people use reputable sources, are armed with good information regarding how to select a reputable source, and are following the advice of their provider.

The media conflates and confuses sources so frequently that it is virtually impossible for the layperson to differentiate based on articles published daily, which is one reason I made this website. When I was considering my options I was in a hurry, in dangerous territory with my blood pressure, looking at my newborn and wondering whether it was a good decision. It ended up being a great decision for me personally, but the fear I had was real. I later felt compelled to share what I researched and this meeting reaffirmed that it is needed more than ever.

Should people be so confused that they are led down the wrong path and get hurt, there is a real danger to the whole industry and national availability of these life-changing medications.

Scott and Tenille also covered marketing terms being used by compounding pharmacies, encouraging them to involve legal council in their marketing material and website development to avoid some of the gaffes being spotted and cease-and-desist orders being sent to organizations who mistakenly involve brand names in their marketing. They cannot be compared. They cannot be mentioned. And because the compounded drugs are "not FDA-approved", an important legal distinction, they cannot be discussed in terms of treating conditions, or efficacy. The conditions they are meant to treat is a discussion between the provider and patient.

The APC also pointed out that the term "not FDA-approved" also applies to many common household over-the-counter drugs, including any therapies developed so long ago that they have never been FDA-approved. The label is not as uncommon as one might think. It is also rightfully said that to say something is FDA-approved isn't to say it is safe. In other words, the discussion about citations in pharmacies and cases of adverse events isn't a real or productive discussion until you are comparing the two products in question side-by-side, rather than just focusing on compounding pharmacies.

There was an in-depth discussion of legality, which I will let the attorneys say eloquently in the full-length video. To summarize would be doing a disservice, but feel free to ask questions if you have any specifics.

One key point is that a pharmacy cannot receive a 503A license and immediately begin to dispense GLP-1 medications, nor to ship to all states immediately. There is a somewhat lengthy period of testing that is required to validate BUD as well as other tests for things like container integrity. See video with Tenille Davis, a compounding pharmacist with 16 years of experience.

From my research and from what I learned in the meeting, there are no pharmacies currently under threat of being shut down. I have seen that mentioned on forums and that was not mentioned or referenced at the meeting. Only that some will need to comply with the legal requirements around appropriate marketing.

I will follow up with slide captures but I wanted to share this asap for discussion.

Alison