Aug 14 (Reuters) - Eli Lilly ( LLY ) has sent
cease-and-desist letters to U.S. healthcare providers in recent
days to stop the promotion of the compounded versions of its
drugs for weight loss and diabetes, as their supply increases,
the company said on Wednesday.
The letters were sent to telehealth companies, wellness
centers and medical spas selling compounded versions of the
drugmaker's popular treatments Zepbound and Mounjaro, a
spokesperson told Reuters.
"When FDA-approved medicines are 'commercially
available', compounders cannot regularly make 'essentially a
copy' of them," the company said in its emailed statement.
Compounded drugs are custom-made medicines that are based on
the same ingredients as branded drugs. Because Zepbound and
Mounjaro, both known chemically as tirzepatide, were in short
supply, they could be legally produced by licensed pharmacies in
the U.S.
However, surging demand for Lilly and Danish rival Novo
Nordisk's weight-loss drugs, which can cost more than
$1,000 for a month's supply, has prompted numerous sellers to
offer compounded versions at lower prices.
Lilly and Novo have previously sued more than three dozen
medical spas, weight-loss clinics, compounding pharmacies and
online sellers in total to stop them from selling products
claiming to contain the active ingredients in their drugs.
The U.S. Food and Drug Administration has listed all doses
of Lilly's drugs as available but has not removed them from the
shortage list.
The FDA said in an emailed response that it was currently
working to determine if the available supply of tirzepatide, the
active ingredient in Mounjaro and Zepbound, would meet its
definition of a resolved shortage.
Last month, the FDA
warned
patients and doctors about dosing errors associated with
compounded versions of Novo Nordisk's weight loss and diabetes
drugs.
The health regulator said it had received reports of
adverse events, some requiring hospitalization, that may be
related to overdoses due to patients incorrectly
self-administering the compounded drug and healthcare providers
miscalculating doses.