Novo Nordisk Tuesday asked the U.S. Food and Drug Administration to ban compounding pharmacies from making copycat versions of its popular weight-loss and diabetes drugs, which it said were too
complex for those manufacturers to produce safely.
U.S. regulations allow compounders to copy brand-name medicines that are in short
supply by combining, mixing or altering drug ingredients to meet demand. Novo’s
Wegovy and diabetes drug Ozempic, both known chemically as semaglutide, have been
in shortage in the U.S. for much of this year.
In its submission, the Danish drugmaker asked the FDA to consider placing semaglutide
on a list of drugs that, even though they are in shortage, are too complex to be copied.
Novo said compounded versions of Wegovy are being sold in incorrect dosage
strengths, have been found to contain unknown impurities, and have been linked to
nearly 400 serious adverse events since 2018.
The FDA told Reuters it was reviewing Novo’s petition and would respond directly to the
drugmaker.Novo said in a statement it wanted to ensure patients only received FDA-approved,
safe, and effective semaglutide products.
The Alliance for Pharmacy Compounding, which represents compounding pharmacists
and technicians, said in its statement that Novo was “confusing the fact that the
semaglutide molecule is demonstrably difficult to manufacture … with the relative
simplicity of compounding with it.”
The FDA this month said it had agreed to reconsider a decision to bar compounders
from selling their own versions of Lilly’s weight loss and diabetes medicines after they
were taken off the agency’s shortage list.
Jeff Newman JD MBA, represents whistleblowers nationwide relating to Medicare and Medicaid fraud, under the state and federal False Claims Act (Qui Tam) and corporate whistleblowers in major claims under the SEC, CFTC and FINCEN whistleblower programs. He can be reached at Jeff@JeffNewmanLaw.com or at 617-823-3217
