FDA comes under Congress scanner over Ranbaxy issue

New York, July 17 (PTI) The U.S. drug regulator FDA,
which has charged Ranbaxy of selling unsafe medicines in the
country, has come under the parliamentary scanner and will be
probed for its conduct in approving the Indian pharma major's
products and other potential violations in the matter.
A Congressional Committee has said that it would examine
Ranbaxy's drug approvals in the U.S. and potential violations
of manufacturing regulations, a media report said.
Besides, the House Energy and Commerce Committee would
also "look at why the FDA continued to approve medicines made
by the company and allow shipments into the U.S. while it was
questioning Ranbaxy's manufacturing processes," the Star
Ledger newspaper reported.
The report said that the Committee "wants to find out
whether the FDA knowingly allowed unsafe and ineffective
medicine to enter the U.S."
The inquiry stems from a federal court filing by the
U.S. Department of Justice, where it has been alleged that
there have been "a pattern of systematic fraudulent conduct,
including submissions by Ranbaxy to the F.D.A. that contain
false and fabricated information about stability and bio
equivalence of the company's generic medications."
The Justice Department has also cited a failure by
Ranbaxy to report in a timely fashion it distributed drugs
that did not meet proper specifications, and has accused the
company of concealing violations of good manufacturing
practice regulations from FDA.
"If these allegations are true, Ranbaxy has imperiled the
safety of Americans in a manner similar to the generic drug
scandal we uncovered twenty years ago," the Star Ledger report
quoted House Energy and Commerce Committee Chairman John
Dingell as saying.