WASHINGTON Two leading U.S. Democrats said on
Tuesday they are investigating whether Food and Drug
Administration knowingly allowed the sale of Ranbaxy RANB.BO
drugs that may have been backed by fraudulent data.
The congressional investigation stems from information
released as part of a probe by U.S. law enforcement authorities
into whether the Indian drugmaker submitted false data to
support generic drug applications and tried to hide
manufacturing violations, the lawmakers said.
Reps. John Dingell and Bart Stupak said in a statement they
want to know if the FDA "knowingly allowed drugs suspected of
being fraudulently approved and manufactured in violation of
Good Manufacturing Practices to continue being sold by Ranbaxy
Inc in the United States."
Ranbaxy Laboratories Ltd, India's largest drugmaker by
sales, has agreed to a $4.6 billion takeover offer from Japan's
Daiichi Sankyo (4568.T).
The lawmakers pointed to a legal motion filed July 3 by the
Justice Department and the U.S. Attorney's Office on the FDA's
The motion, which was seeking to enforce subpoenas for
documents, stated that the FDA was aware of allegations of
fraudulent conduct by Ranbaxy for at least 18 months but did
nothing to remove suspect products from the market, the
"If true, these statements would call into serious question
whether the leadership of the agency ... have met even the
minimum requirements of due diligence," the lawmakers said.
FDA spokesman Christopher Kelly said the agency had
received the lawmakers' letter and would respond directly to
Ranbaxy has denied allegations that it sold misbranded or
adulterated drugs and said it was cooperating with the
three-year-old probe by U.S. authorities.
Dingell chairs the House of Representatives Energy and
Commerce Committee and Stupak heads its investigations
subcommittee. Both are from Michigan.
The lawmakers, in a letter to the FDA, asked for documents
relating to its inspections of Ranbaxy facilities and its
suppliers, plus other information.
(Reporting by Lisa Richwine, editing by Gary Hill and