JURIST - Paper Chase: House committee begins investigation of FDA drug approvals

[JURIST] Two members of the US House of Representatives Committee on Energy and Commerce [official website] began an investigation [information request, PDF; press release] Tuesday into whether the Food and Drug Administration (FDA) allowed the continued sale of certain drugs that agency officials knew had been manufactured and sold using faulty data. The investigation began after the US Attorney for the District of Maryland filed a motion [text, PDF] with the district court early this month seeking to enforce subpoenas against pharmaceutical company Ranbaxy Laboratories [corporate website], which the government suspected of fraud, mislabeling its products, conspiracy and making false statements in violation of federal law. The motion also alleged that the FDA knew of these possible violations for 18 months but took no action. In the Committee's information request, the Representatives wrote:

Unfortunately, the FDA's alleged lack of action to remove these suspect products from the market requires this Committee to review the pre-market approval inspections of all currently marketed Ranbaxy drugs, as well as any "for cause" inspections, to determine if FDA has expended the resources required to justify leaving these suspect drugs on the market.

The Committee has requested all related preapproval and investigatory documents, lists of all suppliers and laboratories that performed bioequivalency tests, and a list of all involved FDA personnel. The FDA must provide the documents within two weeks, and the Committee wants to complete its interviews by the end of August. Reuters has more.

Ranbaxy has previously come under scrutiny by the US justice system and the FDA. In 2005, US District Court Judge Dickinson Debevoise ruled [JURIST report] that Ranbaxy had to stop production of its generic version of Pfizer Inc.'s blood-pressure drug Accupril because Pfizer was likely to win a patent-infringement lawsuit filed against Ranbaxy. In June 2006, the FDA revoked its approval from a Ranbaxy dosage form center, and in February 2007, the FDA raided and closed [Financial Express report] Ranbaxy's US headquarters in New Jersey.

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