Senators Consider Safety Reform at FDA

After weeks of neutrality, a key Republican lawmaker said Thursday that recent internal reforms by the Food and Drug Administration did not do enough to protect patients from drugs with potentially deadly side effects.

Sen. Michael B. Enzi (R-Wyo.), chairman of the Health, Education, Labor and Pensions Committee that has jurisdiction over the beleaguered agency, said he would explore options for bipartisan legislation with Massachusetts Sen. Edward M. Kennedy, the ranking Democrat on the committee.

“Doing nothing to address the current controversies is not an option,” said Enzi, whose committee would handle any FDA reform bill.

Speaking at the close of two days of drug safety hearings, Enzi said he was seeking a “comprehensive response” to the need for congressional action that was acceptable to “both sides of the aisle.”

He said he recently met with the FDA’s leading congressional critic, Sen. Charles E. Grassley (R-Iowa), to discuss possible legislation.

FDA Deputy Commissioner Janet Woodcock, testifying before Enzi’s committee, said the agency had learned its lesson from the recall of Vioxx, an arthritis painkiller withdrawn from the market after a study confirmed long-standing concerns among some experts that it raised the risk of heart attacks and strokes.

“We plan to put information out to the public directly about emerging safety issues,” Woodcock said.

“We will be getting information out to people who need it in a timely manner.”

The FDA also is pursuing other internal reforms, including: creating a drug safety board, setting up a process to fully consider dissenting opinions from its own experts and bringing in an outside group from the federal Institute of Medicine, part of the National Academy of Sciences, to evaluate its safety program.

Woodcock said the agency was more focused on safety than at any time in its history, and that changes were underway that should prevent recurring problems.

But Enzi said he was considering several suggestions for further changes.

Kennedy favors granting the FDA authority to require safety monitoring by companies after a drug has been approved. He called on Congress to increase funding for the FDA’s safety program.

The FDA should have explicit authority, which it does not now have, to order labeling changes for a drug when safety concerns arise, Kennedy said. Currently, the agency must negotiate wording changes with drug makers, a process that can take months.

A key question in any legislation would be the future of the FDA’s drug safety office, now a unit of the division that decides whether a drug should be approved. Woodcock acknowledged there was a potential for drug reviewers to form an “intellectual bias” in favor of a medication they had cleared.

Grassley has said the safety office should be separate from the division that reviews drugs. Many medical experts concur, and some believe the safety office should be an independent agency, modeled on the National Transportation Safety Board. Enzi and FDA management oppose creation of a safety office outside the agency.

Beyond questions of how the FDA should be reorganized, some lawmakers want to consider restrictions on advertising prescription drugs directly to consumers, and curbs on high-pressure industry sales campaigns aimed at doctors.

Two outside experts who testified before Enzi’s committee urged lawmakers to consider sweeping changes.

Dr. Raymond Woosley of the University of Arizona said the drug approval process “fails to detect serious adverse effects of products until they are on the market, often for years, and millions of Americans have been exposed to potential harm.”

That is true in part because pre-approval trials involve relatively small numbers of patients and problems may not appear until larger numbers have been exposed to the drug.

Woosley urged that new drugs be introduced gradually. After initial approval, they would be available only to limited populations of patients, and would have to be used to treat the particular condition for which they were approved.

After a time, the drug could be used more broadly.

Woosley also urged the creation of a computerized registry to track the experience of patients using new drugs, and compare the results with those of patients using older drugs.

Dr. Bruce Psaty of the University of Washington in Seattle said the approval process should give greater weight to resolving potential safety problems. In the case of Vioxx, a theoretical possibility of heart risks was acknowledged, but not fully investigated, before the drug was approved.

“If manufacturers do not address the potential risks and benefits with equal scientific rigor, the FDA must insist they do so, both before and after approval,” Psaty said.

He called for a new Center for Drug Safety, within the FDA, with the authority to order studies or conduct its own, to impose labeling changes, restrict advertising and suspend or withdraw drugs from the market.