February 26, 2009 / 10:32 PM / 11 years ago

Lawmaker asks FDA why a scientist was dropped

WASHINGTON (Reuters) - A Democratic lawmaker asked the Food and Drug Administration on Thursday to explain why it removed a scientist from an advisory panel that reviewed Eli Lilly and Co and Daiichi Sankyo’s proposed blood thinner prasugrel.

Rep. Maurice Hinchey, a New York Democrat, sent a letter to the FDA asking it to explain why Dr. Sanjay Kaul was removed from the panel, which unanimously recommended approval of the drug earlier this month. Kaul had made critical comments about prasugrel before the panel meeting.

The drug, a new blood thinner that would compete with the world’s second-best-selling drug, is the most important product in Lilly’s pipeline. Company data has shown it prevents more heart complications than its rival, Bristol Myers Squibb Co and Sanofi-Aventis SA’s Plavix, but can also increase the risk of serious bleeding.

The FDA has acknowledged it removed Kaul because of his comments.

Earlier this week, Janet Woodcock, head of the agency’s Center for Drug Evaluation and Research, said a series of staff errors prevented the FDA from looking at Kaul’s “intellectual bias” until Eli Lilly contacted the agency about his work.

Lilly spokeswoman Tamara Hull said the company did contact the FDA about Kaul but that it was up to the agency to decide who served on its advisory panels.

“This situation does not instill policymakers with confidence that the FDA is capable of objectively overseeing the drug industry,” Hinchey wrote in his letter.

The FDA often looks to panels of outside experts for advice about experimental treatments before making approval decisions and usually follows their recommendations. It regularly bars those who have financial conflicts of interests, but critics have chided the agency for removing Kaul over his work.

A final decision on prasugrel is pending.

A representative for Daiichi could not be immediately reached for comment. Kaul also could not immediately be reached.

Reporting by Susan Heavey; Additional reporting by Lisa Richwine in Washington and Ransdell Pierson in New York; Editing by Gary Hill

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