Senators Prepare to Unveil New Drug Safety Proposals

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Senators Prepare to Unveil New Drug Safety Proposals

By GARDINER HARRIS

Published: June 21, 2006

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, B. Enzi, Republican of Wyoming and chairman of

the Health, Education, Labor and Pensions Committee, and 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, 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 E. Grassley, Republican of Iowa and chairman of the

Senate Finance Committee, and Senator 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.

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.