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Senators Prepare New Drug Safety Proposals

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The New York Times
June 21, 2006

WASHINGTON, June 20 — After more than a year of quiet negotiations, two influential senators are expected within weeks to introduce a legislative proposal that could drastically change how drugs are tested and approved in the United States.

The senators, Michael B. Enzi, Republican of Wyoming and chairman of the Health, Education, Labor and Pensions Committee, and Edward M. Kennedy of Massachusetts, the ranking Democrat on the committee, still refuse to speak about the proposal, representatives for both said.

But committee staff members have for weeks been showing legislative talking points to drug industry representatives, scientists and others on Capitol Hill to help tailor the proposed legislation and build support for it.

In broad terms, the bill would require that drug makers disclose the results of all large human tests of their drugs, known as Phase 3 and Phase 4 trials; create a detailed risk management plan to uncover and control any safety problems that arise after a drug is approved; and pay penalties if they fail to follow through with this plan, according to four experts who were briefed on the proposals.

The experts spoke on condition that their names not be used because they had told members of the senators' staffs that they would not talk publicly about the proposals.

A spokeswoman for the Food and Drug Administration, Susan Bro, said the agency had not yet reviewed the proposed legislation. She said the agency had already undertaken "a number of initiatives" to improve itself.

"We always welcome additional ideas on improving oversight of drug safety," Ms. Bro said.

The senators plan to introduce the bill before Congress recesses in August, those briefed on the proposal said.

Senator Charles E. Grassley, Republican of Iowa and chairman of the Senate Finance Committee, and Senator Christopher J. Dodd, Democrat of Connecticut, have offered legislation similar in some respects to the Enzi-Kennedy proposal. But Mr. Enzi presides over the committee that has direct oversight of the drug agency, and Mr. Kennedy has specialized in health legislation for decades. Their imprimatur carries great weight on bills dealing with the agency.

It is unlikely that Congress will act on the proposal before the November election, and any action may be delayed until 2007, when Congress must reauthorize the formula by which the F.D.A. receives tens of millions of dollars in fees from drug makers. The Enzi-Kennedy proposal calls for an increase in those fees to pay for greater oversight of drug safety by the agency, before and after a medicine is approved. How such an increase could be approved apart from next year's reauthorization is unclear.

Daniel E. Troy, a former general counsel of the drug agency who now represents drug companies, said it would be a mistake for Congress to combine the Enzi-Kennedy proposal with next year's negotiations over extending the fees.

"If what we hear is true," Mr. Troy said, "my concern is that these issues are too complex to get mixed up with the reauthorization of the Prescription Drug User Fee Act."

Dr. Sidney M. Wolfe, director of health research for the consumer advocacy group Public Citizen, said he was encouraged by some of the Enzi-Kennedy proposals, particularly one that would exact monetary penalties from drug makers who fail to follow through on their own drug safety promises.

"There really is a crisis at the F.D.A.," Dr. Wolfe said.

The proposals come after a series of drug withdrawals led agency critics and some on Capitol Hill to suggest that the agency was failing in its mission to protect the public from dangerous drugs. Since 2000, pharmaceutical companies have withdrawn 10 drugs after deaths and injuries demonstrated that the medicines were unsafe.

In addition, the agency has only recently learned that widely prescribed antidepressants can cause some children and teenagers to become suicidal; that hugely popular pain pills are likely to increase the risk of heart attacks; and that commonly used antipsychotic drugs and stimulants may be more dangerous than was previously known.

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