Comment from Folk Adam

I am writing to respectfully urge the FDA to INCLUDE semaglutide, tirzepatide, and liraglutide on the 503B approved compounding list. The reasons are multiple, as I will describe in detail below. First and foremost, there is a medical need that these medications fill that simply, at this time, cannot be filled by name brand versions of these drugs. Customized doses, additives, and schedules are of chief importance to many patients. The customization is valuable for managing side effects, weight loss that is too rapid, and the half-life of the medications that render it ineffective after a certain time frame. Second, obesity is a public health crisis that the FDA should be fighting with every method available. Failure to approve these GLP-1 medications on the approved 503B bulk list will undoubtedly force many people to make a decision of quitting the medication and returning to obesity with all the comorbidities they've worked so hard to overcome, or turning to gray-market suppliers, which carry far more risks than FDA inspected compounders. Third, the FDA declared the shortages of these medications to be over. That is simply the wrong conclusion. If everyone that is currently taking a GLP-1, both compounded and name brand, supplies would not be able to keep up. The end of the shortages is being facilitated through high costs and insurance denials. I've seen firsthand the benefits these medications can have on people's health, and the true need for them isn't being represented because of the cost barrier. ~72% of Americans are overweight or obese. Only 12% are currently on one of these medications. If everyone that could benefit from these medications was able to afford it, there would be a massive shortage. The shortage is still there, but the Pharmaceutical industry is fabricating a falsehood by using price to secure supply. Fourth, there is already major distrust of the FDA among the public. The FDA is supposed to keep people safe and healthy. But by saying compounded GLP-1 medications are safe to take when there's a shortage, but not safe to take when there's no shortage, creates a duality of mistrust. Either they were never safe to begin with and they're not safe now, or they were safe then and they're safe now. Either way, the seeds of even further distrust of our public health officials have been sewn. The FDA kowtowing to Pharmaceutical profit over public health puts a black eye on the administration that should have the health of Americans as its core value. Eliminating obesity, through safe, affordable compounding options should be a priority to support, not oppose. Fifth, if anything was learned from the COVID pandemic and the vaccine fiasco that followed, it's that Americans should have the right to choose what goes in their own bodies, so long as they accept the consequences that come with it. Semaglutide, tirzepatide, and liraglutide have already been proven as safe and effective, and care providers desperately want their patients to be healthier, and for ~72%, that starts with losing weight. By siding with Big Pharma, the FDA is essentially committing to making and keeping Americans more overweight and less healthy. That is not the message the administration should be sending. In conclusion, I strongly urge the FDA to INCLUDE semaglutide, tirzepatide, and liraglutide on the 503B bulk list. For the reasons of medical need, public health, true supply shortage, FDA perception, and personal choice, it is the only logical conclusion that can be made. How many more people need to develop obesity related cancers and diseases that could've been prevented? How much more strain do we need to put on the public health system treating diabetes when it could be prevented? The decision of whether or not to include GLP-1 medications on the 503B bulk list will have public health ramifications for decades to come. Please, stand up for the American people. Plain and simple, DO YOUR JOB and fight for all Americans, not just the wealthy. Thank you.