Lawmakers Dredge FDA for Ranbaxy Inspection Documents
Two congressmen have launched an investigation into whether the FDA allowed drugs made by Ranbaxy to be sold in the U.S. despite knowing it had approved them based on fraudulent information and they were made in violation of good manufacturing practices.
Reps. John Dingell (D-Mich.), chairman of the Committee on Energy and Commerce, and Bart Stupak (D-Mich.), chairman of the Subcommittee on Oversight and Investigations, sent a letter to FDA Commissioner Andrew von Eschenbach requesting information on each Ranbaxy drug the FDA has approved.
The letter comes roughly a week after India-based Ranbaxy defended itself against allegations in a Justice Department motion that it and consultant Parexel had withheld subpoenaed documents and thwarted an investigation over alleged fraud and conspiracy involving applications for generic drugs and distribution of AIDS therapies.
Justice, through the U.S. State Attorney’s Office for the District of Maryland and the Civil Division, Office of Consumer Litigation, maintains the company submitted false information about stability and bioequivalence to support ANDAs for anti-retrovirals distributed by the President’s Emergency Plan for AIDS Relief, a five-year, $15 billion program aimed at combating HIV and other diseases in 114 countries.
The government is probing whether Ranbaxy used active pharmaceutical ingredients (API) from unapproved sources, blended approved with unapproved API and put less API in drugs than approved by the FDA. It had subpoenaed certain documents, some of which the company refused to provide.
Ranbaxy subsequently said it would turn over all requested documents.
A copy of the letter is available at energycommerce.house.gov/Press_110/110-ltr.072208.FDA.Ranbaxy.pdf.<