Semaglutide removed from shortage list
It happened sooner than we expected -- the FDA has announced Semaglutide shortage resolution, removing it from the shortage list.
As announced by Novo Nordisk and the FDA itself, the shortage designation on Semaglutide has been lifted:
Center for Drug Evaluation and Research
FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand. Patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.
GLP1.Guide covered this likelihood recently and have been waiting for clarification/development – unfortunately development happened even sooner than we anticipated.
Similar to the current stalemate, the FDA is pledging not to take action against compounding pharmacies to ensure that people are able to receive the crucial medications that GLP1 Receptor Agonists are now known to be.
The FDA statement
The FDA statement lays out clear guidelines for steps that compounders and outsourcing facilities must take:
For a state-licensed pharmacy or physician compounding under section 503A of the FD&C Act: compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved product within 60 calendar days from today’s announcement, until April 22, 2025.
For outsourcing facilities under section 503B of the FD&C Act: compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved drug product within 90 calendar days from today’s announcement, until May 22, 2025.
While it has been discussed in the past, it is unlikely that additives like B12 (which often produces "pink" Semaglutide) will enable compounders to escape the section 503 restrictions.
While the FDA has ensured an off-ramp for gradual phasing out of compounding pharmacies, it is clear in it's decision and this will almost certainly harm accessibility for GLP1s in the short term.
Compounders open a new lawsuit against the FDA
While it seems almost like a case of Deja Vu, compounders are suing again over their impending inability to compound Semaglutide-based GLP1 treatments:
While the first round of lawsuits arguably had the effect of encouraging the FDA to not take action against comopunders, it's unclear that this round of legal action will be very effective in stopping eventual legal action against compounders for violating the laws as currently written.
GLP1 Receptor Agonist formulations that are still in shortage
The FDA is also clear about which formulations are still considered "in shortage".
Dulaglutide injection: In shortage. Manufacturer has reported all presentations are available.
Liraglutide injection: In shortage. Manufacturer has reported two presentations are available, and three have limited availability.
While Liraglutide is listed, it's clearly not in the same sort of shortage as Semaglutide or Tirzepatide which have recently been taken off the shortage list. Liraglutide is currently being produced by two large pharmaceutical corporations which produce generics at scale:
GLP1.Guide Staff
GLP1.Guide Staff
There's no similar news about Dulaglutide, but as the patent is a compound patent, it may not be producable by generics companies until 2026.
The short term impact on supply
While paradoxically the FDA has reached a decision on supply of GLP1s being adequate, it is quite clear to the common consumer that it is still hard to purchase GLP1s for an affordable price.
What this does is restrict supply from non-manufacturer organizations (decreasing overall supply of GLP1 formulations), but that is indeed how pharmaceutical patent protections are intended to work (and arguably incentivize development of new medications).
It remains to be seen where this leaves companies like HIMS who offer compounded GLP1s, and what they will be able to do to deal with this change in regulation.
The average consumer will be able to rely on compounders for their GLP1 supply for the short term, but clearly that will not last, an it is unlikely that the current lawsuits will change that reality.
