Oct 11 (Reuters) - The U.S. Food and Drug Administration
on Friday agreed to reconsider a decision it made last month to
bar drug compounders from selling their own versions of Eli
Lilly's ( LLY ) blockbuster weight loss and diabetes drugs.
The agency said in a court filing it would now allow
compounding pharmacies and facilities to keep providing the
drugs while it reviews whether there is a shortage of their
active ingredient. The compounding versions of the drugs are
cheaper for patients than the brand-name versions.
The decision was in response to a lawsuit brought on Monday
by the Outsourcing Facilities, Association, a compounding
industry group. After the FDA's decision on Friday to
reconsider, U.S. District Judge Mark Pittman in Fort Worth,
Texas put the lawsuit on hold.
The Sept. 30 decision by the FDA endangered the ability
of compounders to sell versions of Lilly's weight loss drug
Zepbound and diabetes drug Mounjaro. The FDA decision
removed their active ingredient
, tirzepatide, from its list of drugs experiencing
shortages.
That would have cut off access for many patients to the
compounded versions they relied on during the shortage, which
are cheaper than the brand name drugs. Insurers generally cover
drugs like tirzepatide for diabetes, but many do not cover them
for weight loss.
Shortages of Lilly's drugs and competitors like Novo
Nordisk's Ozempic have fueled demand for compounders'
versions. Mounjaro had been on the FDA's list of drugs in short
supply since late 2022, while Zepbound was added in April.
Compounded drugs, unlike conventional brand-name or
generic drugs, are sold without first getting FDA approval.
Compounding pharmacies may create drugs to fill prescriptions
for specific patients, while so-called outsourcing facilities
prepare compounded drugs in bulk.
Federal regulations allow compounded versions of an
FDA-approved drug to be sold to meet demand if the drug is in
short supply. If there is no shortage of a drug, compounded
versions of it cannot be made regularly or in large amounts.
The Outsourcing Facilities Association claimed in its
lawsuit that the FDA removed tirzepatide from its shortage list
even though it remained in short supply.
Lilly in August
began sending cease-and-desist letters
to telehealth companies, wellness centers and medical spas
selling compounded versions of Zepbound and Mounjaro. The
company has also
filed lawsuits
against sellers falsely claiming to sell FDA-approved
versions of the drug.
The active ingredient in Novo Nordisk's drugs,
semaglutide, remains on the FDA's shortage list.