The battle for compounded GLP1 continues
The battle for compounded GLP1s rages on -- powerful organizations with profit incentives continue to push for compounded GLP1s, with consumers caught in the middle.
Last year, Tirzepatide came off the the FDA shortage list and GLP1 compounders sued to continue compounding the massively popular drug. The fight is far from over, though the FDA has not turned back on the decision to remove the drug from the shortage list.
Instead what we have now is a situation in which the FDA has promised (via a related court filing) to not pursue legal action against compounders:
GLP1.Guide Staff
This is clearly not a sustainable position for the industry, and it's only a matter of time until legal action continues or other drugs (for example Semaglutide, the active ingredient in Ozempic and Mounjaro) come off the shortage list.
Compounders can only produce versions of drugs that are in shortage legally, and that's going to be a problem going forward.
So what's changed?
New cases against compounded drugs are popping up
There have been some recent developments in negative perception of compounded drugs.
Medical professionals are beginning to caution more heavily against compounded solutions. While the average person who finds it difficult to afford GLP1s without health insurance sees compounded drugs as a solution, the unreliable nature (and currently profitability) of compounding GLP1s attracts companies that may cut corners in order to increase their profits.
Recently Canada has recalled drugs created by a compounding phramacy:
Saba Aziz
The drugs were compounded by Alberta-based Create Compounding Pharmacy and comprised semaglutide, which belongs to the GLP-1 class of drugs, and pyridoxine, which is a form of vitamin B6.
Many thought that combining Semaglutide with a formulation like Vitamin B12 or B6 would be enough to avoid rules regarding shortages and pharmacological patents, but that argument is unlikely to hold water.
Meanwhile, companies like HIMS in the US have fully embraced compounding, and are touting the benefits of adding a new line of business to investors.
Compounders are facing higher scrutiny amidst advertising failures
The increased amount of companies offering GLP1s and not disclosing properly their methods of manufacturing is drawing the ire of groups of professionals and researchers.
10.1001/jamahealthforum.2024.5018
The numbers are staggering:
During the study period, 98 unique websites sold any GLP-1 RA, of which 79 sold compounded GLP-1 RAs or a prescription for compounded medications and were included in the analysis. All 79 websites sold compounded semaglutide, 57 (72.2%) sold compounded tirzepatide, and 3 (3.8%) sold compounded liraglutide (Table 1). Median (IQR) first-month price, including discounts, for compounded semaglutide, tirzepatide, and liraglutide was $231 ($189-$294), $330 ($275-$399), and $248 ($223-$274), respectively. Fifty-two websites (65.8%) featured a mark of certification, 50 of which displayed LegitScript certification. Two websites (2.5%) did not provide prescriptions for compounded GLP-1 RAs and required a prior prescription.
It's clear why these companies are popular and why they're coming under scrutiny – there is a very real competitive landscape and a financial benefit to hiding the sources of the semaglutide/tirzepatide or liraglutide being sold.
Given that non-insured Semaglutide or Tirzepatide can cost $1000/month for the average consumer, there is intense competition around the $250/month price range for companies working with comopunders. Clearly there's also enough profit left to go around that there are almost 100 (at least!) of these companies competing in the market place.
While some require a prior prescription, clearly the killer use case for telemedicine has become the prescription of drugs that would otherwise be hard to obtain.
Manufacturers are pushing for a ban
As one might expect, manufacturers like Novo Nordisk and Eli Lilly are not too excited about the amount of compounding happening – Novo Nordisk has joined Eli Lilly in seeking a ban on compounding:
The FDA continues to focus on educating consumers
Consumers are undoubtedly interested in and benefitting from the use of GLP1s. The FDA is watching this trend grow and rolling out new resources for people to access:
What is interesting is that although there is oversight in place for compounding pharmacies:
Generally, state boards of pharmacy have primary responsibility for the day-to-day oversight of state-licensed pharmacies that are not registered with FDA as outsourcing facilities. FDA does conduct surveillance and for-cause inspections of state-licensed pharmacies that are not registered as outsourcing facilities.
Facilities that register with FDA as outsourcing facilities under section 503B are primarily overseen by FDA and inspected by FDA according to a risk-based schedule.
The onus to produce accurate marketing is also enforced at the federal level:
Under federal law, prescription drug promotion disseminated by or on behalf of drug manufacturers, including compounders, must be truthful, non-misleading and accurate.
However even with these protections in place, the FDA still passes the requirement for vigilance onto the average consumer:
FDA encourages consumers to:
- remain vigilant
- understand the risks of buying prescription medicine from online pharmacies or telehealth platforms
- talk to a healthcare provider about questions related to prescription drug
Seeing the explosion in growth and interest around GLP1s, NPR has also taken the chance to explain the situation more thoroughly:
In the face of overwhelming demand, and an unclear legal framework with powerful entities threatening legal action and with opposite goals, it's not clear that there's much governmental organizations can do without drawing ire.
It is likely that this gray zone will continue only while harms from compounded GLP1s continue to seem rare.
As far as compounded GLP1s go, for the general public the benefits may still outweigh the risks.
