Indian
regulators will be told when the U.S. Food and Drug Administration is
inspecting plants that produce generic drugs in that country, and will join to observe
FDA standards.
The
agreement between Indian government officials and FDA Commissioner Margaret
Hamburg came during her visit to India this week, the FDA said on 10 February.
Hamburg, who told last week she will expand overseas plant inspections, also
met in a closed-door session with 16 drug companies and affiliated groups in
India to discuss manufacturing quality.
U.S.
lawmakers are scheduled to hear from doctors, researchers and patient advocates
in a Feb. 26 briefing on whether substandard generic drugs are leaking into the
U.S. medical system from overseas. Harry Lever, a Cleveland Clinic
cardiologist, said he will tell them that generic drugs made by India-based
companies for heart failure often don’t work the way they should, opening
questions about the FDA’s ability to keep track of India’s growing generic
business.
Lever
said he is awaiting test results from samples on the questionable drugs sent to
Preston Mason, a researcher at Brigham & Women’s Hospital in Boston. Mason
previously examined generic versions of Pfizer Inc. (PFE)’s Lipitor from 15
countries, and found manufacturing impurities sometimes rendered the drugs
ineffective.
Pills
produced by U.S. generic-drug makers Mylan Inc. (MYL)
and Actavis Plc (ACT)
weren’t contaminated, according to Mason’s report on his research published in
the June issue of the Journal of Clinical Lipidology.
In
2012, the FDA was given the power to collect fees from generic-drug makers in
part to pay for an increase in inspections of facilities outside the U.S. While
India’s government has cleared the way for the FDA to increase the number of
its staff members to 19 from 12, it’s not clear how many are based there now.
The agency has declined to provide a number.
Congressional
aides are watching how well the FDA ramps up overseas inspections and may bring
up the issue of drug quality as part of an FDA oversight hearing in the Senate
in a few months, according to a staff member with the Senate Health, Education,
Labor and Pensions Committee who wasn’t authorized to
speak publicly on the issue.
Generic-drug
makers Ranbaxy Laboratories Ltd. (RBXY) and Wockhardt
Ltd. (WPL), whose executives were among those attending the meeting with
Hamburg, have been banned from selling medicines in the U.S. from Indian plants
due to quality concerns. In the latest incident last month, a fourth Ranbaxy
facility was banned from U.S. exports after FDA inspectors found drugs were
re-tested to gain favorable results after initial
analyses failed.
Ranbaxy
Chief Executive Officer Arun Sawhney
said at the time it was “clearly unacceptable” and appropriate action would be
taken after an internal investigation.
Hamburg
turned down a request from Sawhney during the meeting
to allow Ranbaxy to export products from the banned facilities while they are
improved, the Economic Times reported, citing two people at the closed-door
meeting who asked not to be named.