US senator questions new drug safety effort

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At least one key member of the U.S. Senate is not yet satisfied with efforts by the Food and Drug Administration to improve drug safety by creating a new Drug Safety Oversight Board.

“If that is going to work, you’re going to have to take ownership of it,” Senate Finance Committee Chairman Charles Grassley warned Health and Human Services Secretary Mike Leavitt at a hearing Wednesday.

"It’s going to have to be outside the FDA, not inside the FDA,” said Grassley, a Republican senator from Iowa.

As explained Tuesday by Leavitt and acting FDA Commissioner Lester Crawford, the new board would in fact reside within the FDA and report to the commissioner, although members would come from both the FDA and other federal health agencies.

Grassley also said he is working on legislation to better separate FDA’s existing Office of Drug Safety from the office that approves drugs for market.

Drug safety officials “can’t be under the thumb of the Office of New Drugs,” he said, which was essentially what FDA drug safety officer Dr. David Graham told the committee last year. Graham said he was prevented from publicizing data he had compiled showing the dangers of the arthritis drug Vioxx, which its maker pulled from the market last fall.

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