Dr Sanjay Kaul was removed from panel reviewing prasugrel

*Prasugrel blood thinner made by Eli Lilly, Daiichi Sankyo

*House subcommittee to send letters to Lilly, FDA

*Eli Lilly says it contacted FDA about scientist

*Prasugrel the most important drug in Lilly pipeline (Recasts with House investigation, adds details, byline)

By Susan Heavey

WASHINGTON, Feb 26 (Reuters) - Congressional investigators are probing the U.S. Food and Drug Administration's decision to remove a scientist from an advisory panel that reviewed Eli Lilly and Co <LLY.N> and Daiichi Sankyo's <4568.T> proposed blood thinner prasugrel, a spokesman told Reuters on Thursday.

The FDA pulled prominent cardiologist Dr. Sanjay Kaul from the panel after Eli Lilly contacted the agency about his publications and media interviews, which cite concerns about the drug's safety.

Lawmakers are concerned the FDA may have been swayed by the drugmaker and acted in the companies' interests rather than for the public good.

The U.S. House Representatives Energy and Commerce Subcommittee on Oversight and Investigations plans to send letters of inquiry to both the FDA and Eli Lilly within days, the subcommittee's spokesman Nick Choate said.

Led by Democrat Rep. Bart Stupak, the subcommittee "is also investigating the issue and will be requesting further information from the FDA and Eli Lilly," he said.

The move comes after another House Democrat, Rep. Maurice Hinchey, in a separate letter earlier on Thursday asked the FDA why it removed Kaul from the panel, which unanimously recommended approval of the drug earlier this month.

Prasugrel, 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 <BMY.N> and Sanofi-Aventis SA's <SASY.PA> <SNY.N> Plavix, but can also increase the risk of serious bleeding.

Both drugs prevent dangerous blood clots in heart patients.

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.

Representatives for Lilly and Daiichi said the companies 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 to the FDA.

Kaul, who works at Cedars Sinai Medical Center in Los Angeles, could not be reached for comment.

It was not immediately clear if the letters would lead to hearings or other congressional action.

Analysts have said that even if Congress investigates, it would only lead to a small delay in the drug's approval. A final FDA decision is pending for prasugrel, which won European approval on Monday under the brand name Efient.

The FDA often looks to its panels of outside experts for advice about experimental therapies 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 comments.

Last week, advocacy group Public Citizen Health Research Group called on the FDA to clarify its policy on bias. "The case of Dr. Kaul creates the appearance of a lack of such a policy, or the flawed execution of one if it exists," it said in a letter to the agency.

The group also urged a boxed warning for the drug if it gets approved as well as further studies.

On Feb. 3, the FDA's advisory panel voted 9-0 in favor of approving prasugrel, saying it could offer an alternative for some patients and that its benefits justified the additional bleeding risk in certain cases.

Woodcock, talking to reporters on Monday, blamed low-level officials for not properly screening Kaul's paperwork or talking to their superiors before allowing him on the panel in the first place.

"At every step of the way some error was made," she said, adding the agency has put new procedures in place.

"We feel we had nine extremely competent individuals who were able to give us advice," she said. "Dr. Kaul was not included among the advisers at this meeting but we don't believe that invalidates the results of the panel."

But another FDA official said Kaul should have been included, despite his comments.

"In my own personal opinion, I didn't see anything in those writings or in those statements that would preclude him from serving as a member of the committee ... I think he would have been a very valuable member of the committee," John Jenkins, head of the FDA's office of new drugs, said. (Additional reporting by Lisa Richwine in Washington and Ransdell Pierson in New York; Editing by Gary Hill)

AlertNet news is provided by