Sept 5 (Reuters) - The U.S. Food and Drug Administration
is tightening oversight of imports of GLP-1 drug ingredients,
used for weight loss and diabetes, amid concerns that many of
the items may be adulterated and pose a safety risk.
The move comes as the FDA cracks down on unapproved
compounded drugs, which had filled the gap during shortages of
patented treatments. Soaring demand for Novo Nordisk
and Eli Lilly's ( LLY ) obesity drugs has fueled a booming
global market for cheaper, and sometimes even counterfeit
versions.
The health regulator said it had previously identified
serious concerns with compounded weight-loss drugs, including
dosing errors, use of unapproved salt forms and side effects,
with some requiring hospitalization.
As part of its heightened scrutiny, the FDA sent an import
alert on Friday authorizing detention without physical
examination (DWPE) at U.S. ports. This will allow the agency to
seize shipments that appear to be non-compliant with federal
requirements, without inspecting them on arrival.
Importers must now provide proof of quality and compliance
before their goods are released.
The FDA evaluated 48 manufacturing sites outside the U.S.
and found 21% of them as non-compliant.
The regulator will also maintain a separate "green list" -
identifying firms or products that have resolved compliance
concerns and are not subject to automatic detention at the
border.
Under the "green list", the agency identified sources in
Belgium, Canada, China and India, among others, meeting its
criteria, and hence are excluded from DWPE.