Compounding Pharmacies Fight the Stigma of Unapproved Drug Manufacturing
(Thursday, January 4, 2024)
Last year’s biggest drug was semaglutide, the weight-loss drug marketed by Novo Nordisk as Wegovy and Ozempic. Both these drugs are currently in shortage which means that compounding pharmacies are allowed to compound them from active ingredients on prescription, and they have been. Novo pushed back by filing patent infringement lawsuits against a few compounding pharmacies but late last year, the compounding pharmacies pushed back citing regulations that permit manufacture/compounding of these drugs when they are in “currently in shortage” per the FDA, irrespective of their patents.
Under the law, drugs “currently in shortage” can be compounded. In its guidance document from 2018, the compounded drugs must use the same active pharmaceutical ingredient (API), similar formulation, and route of administration. Such compounded drugs are considered “essentially a copy of a commercially available drug product” and not a generic and do not require formal approval by the FDA to be provided to patients. The law does not distinguish between patented or off-patent drugs.
But there are several misperceptions about the compounded versions of semaglutide, and a similar drug, tezirpatide marketed by Eli Lily as Mounjaro. The compounding pharmacies do not like the terms “unapproved drugs”, “generics” or “knock-off” for the drugs they compound. They are unhappy that FDA has not stepped up to clarify the misperception but rather has contributed to the confusion by making vague statements.
In their statement, the Alliance for Pharmacy Compounding (APC), the national association of more than 100 FDA-registered compounding pharmacies, clarified the rules as they exist and their assertion that compounded drugs do not carry the stigma of being “unapproved drugs” sold without FDA approval which in turn could affect patient and doctor comfort with using these essential drugs.
This case is expected to play out this year in one of two ways. Novo and Eli Lily could expand their manufacturing to take their drugs off the FDA’s “currently in shortage” list. Or they could win the court cases they filed against a few deterring all others to stay away from compounding these drugs. It is second outcome that scares APC more as that would affect all compounded drugs, not just these few.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC