The Government’s Warning Shot? FDA and HHS Turn Up the Pressure on Compounding

Are compounders on notice?  FDA may be coming for at least one of them, with a little help from its friends at the Justice Department.

On the heels of the Novo Nordisk’s Wegovy® pill launch, Hims & Hers, in a headscratcher of a promotional move, doubled down on its own compounded semaglutide pill formulation. This likely was the spark that caused FDA’s Commissioner Marty Makary to tweet a not-so-subtle threat to compounders:

FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products.

The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.

FDA followed up with a Press Release announcing the Agency’s “intent to take decisive steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies — including Hims & Hers and other compounding pharmacies — as similar alternatives to FDA-approved drugs.”  FDA also stated that “companies cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA” nor can they state, even if true, that “compounded drugs use the same active ingredient as the FDA-approved drugs or that compounded drugs are clinically proven to produce results for the patient.”  And, the Agency concluded, compounders of GLP-1 products “should be aware that failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.”  HHS’s General Counsel Mike Stuart—who is reportedly leaving his General Counsel role after a shake-up at HHS—  announced, also on X, that Hims & Hers would be referred to the DOJ for investigation concerning potential violations of the FDC Act.

Likely as a result of this increased attention, Hims & Hers decided to pull its compounded Wegovy pill from the market, and others are likely to follow.  But to really make matters worse for Hims & Hers, Novo Nordisk filed its first compounding-related patent infringement lawsuit (to our knowledge) against the telemedicine giant, alleging patent infringement relating to both the pill and injectable forms of semaglutide.

But is the API used by compounders “illegal”?  The “test” in FDCA section 503A addressing what active pharmaceutical ingredients (API) may be used in compounding is relatively straightforward. The compounding of copies of commercially available drug products is legally permissible if done consistent with section 503A’s essential copies statutory framework (for reasons not relevant here section 503B outsourcing facilities cannot compound using semaglutide or tirzepatide API).  For example, if the copy is on FDA’s published drug shortage list, compounded copies are fair game (in fact, shortages are what started the onslaught of GLP-1 compounding).  And what exactly a copy is can cause disagreement, as the statute does not really define “essentially a copy.”  FDA, in non-binding guidance, explains that “identical” or “nearly identical” applies where the FDA-approved drug and the compounded drug have the same active ingredient(s), route of administration, dosage form, dosage strength, and excipients.  FDA further permits the dispensing of compounded formulations where there “is a change . . . which produces for that patient a significant difference . . . between the compounded drug and the comparable commercially available drug.”  So, in some cases, copies may not actually be prohibited “essentially copies.”  FDA seems to be saying that that section 503A’s exemptions do not give a compounder carte blanche to compound anything and everything using the same API that is in the FDA-approved drug, and more importantly, aggressively promote the allegedly “different” compounded formulation on the heels of the launch of a similar FDA-approved product.

The explosion of interest in compounded medications is relatively new, arising during the past four years due in part to the success—and shortage—of weight loss medications.  That shortage  permitted compounding of identical copies of the shortage GLP-1 drugs.  And that door, once opened, is difficult to close.

But GLP-1s are hardly the only medications that are compounded; compounded medications are used ubiquitously across the United States.  FDA’s grumblings on potential enforcement may be applied broadly.  While FDA seems to be tightening its regulatory scrutiny of GLP-1 compounders now, the Agency could refocus on compounders of other compounded formulations, particularly when a new drug receives approval, and is not in shortage.  It is thus critical to take note of the Agency’s position and follow whether FDA or state boards attempt to limit compounding of other copied FDA-approved products.  Compounders must continue to be mindful about what they are compounding—and what they say about their compounding practices—lest they find themselves caught in the FDA’s cross-hairs.