FDA lawyer collaborated with drug firms - lawmaker

The U.S. Food and Drug Administration’s top lawyer has inappropriately intervened in a number of civil lawsuits on behalf of drug and medical device makers, a U.S. lawmaker charged on Tuesday.

U.S. Rep. Maurice Hinchey, a New York Democrat, said the agency’s chief counsel, Daniel Troy, filed friend-of-the-court briefs for drug companies in at least four cases where they were defendants, including one on behalf of his former client Pfizer.

Troy also met with pharmaceutical industry lawyers and representatives before filing the briefs, said Hinchey, a member of the House Agriculture Appropriations Subcommittee, which oversees the agency.

Instead of protecting the public, Troy was “making it the agency’s mission to protect the drug companies from being held accountable when their products do serious harm,” said Hinchey.

In the Pfizer case, Flora Motus of California claimed the company’s antidepressant Zoloft caused side effects that led to her husband’s suicide. The case was dismissed.

Other companies that Troy either met with or supported with legal briefs include SmithKline Beecham Consumer Healthcare, a unit of GlaxoSmithKline Plc, and California-based Pacesetter Inc. among others, according to Hinchey.

Troy could not immediately be reached for comment.

FDA Acting Commissioner Lester Crawford said Troy followed the agency’s ethical policies and recused himself from government work that involved former clients for one year after his appointment in August 2001.

“Any allegation that he has not conducted himself in compliance with applicable legal and ethical rules is simply false,” Crawford said in a statement.

But some experts said Troy’s actions, while perhaps not illegal, are inappropriate.

The Washington-based liberal think tank Center for American Progress on Tuesday alleged that court documents showed Troy “counseled pharmaceutical industry insiders on how to escape oversight from his own agency.”

Allison Zieve, a staff attorney for consumer advocacy group Public Citizen, said the FDA previously refrained from taking sides in private lawsuits.

On Tuesday, the House of Representatives passed an amendment by voice vote that cuts $500,000 from Crawford’s direct budget and adds that amount elsewhere in the agency to “ensure the accuracy of drug advertisements.” Hinchey sponsored the amendment, which is part of the pending agriculture bill.

Provided by ArmMed Media
Revision date: June 14, 2011
Last revised: by Jorge P. Ribeiro, MD