Washington Editor

WASHINGTON - Sens. Edward Kennedy (D-Mass.) and Mike Enzi (R-Wyo.) on Wednesday acknowledged worries that their drug safety legislation could limit the practice of medicine, indicating that they're working to find an appropriate middle ground between ensuring access and safety.

Their comments came at a hearing of the Senate Health, Education, Labor and Pensions Committee, which focused both on their bill and reauthorizing the Prescription Drug User Fee Act (PDUFA) for the third time. Kennedy, the panel's chairman, and Enzi, its ranking member, said they believe that giving the FDA new legislative authorities around drug safety goes hand in hand with PDUFA.

Considering those issues in tandem represents "an attempt to strike the right balance," Kennedy said, to provide the agency with appropriate financial support for reviewing and approving new drugs with proper regard for safety. "The need for swift review does not mean that drugs should be rushed to market," Kennedy said.

Their bill, the "Enhancing Drug Safety and Innovation Act," or S. 484, includes a risk-management component that troubles many in the drug industry: risk evaluation and mitigation strategies (REMS). REMS would require regular reports on adverse events associated with all drugs, and also could restrict advertising and limit product use or distribution to address an expected serious risk.

"While the PDUFA program is a system the public can always count on," Enzi said, "it can and should be improved."

However, critics said the addition of the safety proposals to the user fee renewal would add redundancies to the FDA's existing powers. Instead, they say a less prescriptive construct that lays out principles for the agency to develop and apply risk mitigation tools would provide flexibility and less severely hinder medical practices.

"I think you've got all the tools that are currently in this bill," Sen. Richard Burr (R-N.C.) told FDA Commissioner Andrew von Eschenbach, who testified at the hearing. Going a step further, Sen. Tom Coburn (R-Okla.) said he's "very worried" about restrictions that would come with the Kennedy-Enzi bill, referring to possible limits on off-label prescribing and restricting certain prescriptions to certain specialists. A physician himself, Coburn cautioned against taking "judgment out of the FDA."

Kennedy disagreed that the safety bill would curtail off-label prescriptions, and said the measure is written to provide the agency oversight authority that is "flexible enough to be tailored to the unique characteristics of each new drug."

Debate on the bipartisan legislation took center stage at the standing-room-only hearing, during which lawmakers spent less time directly discussing the FDA's industry-negotiated PDUFA proposal, details of which were released earlier this year. The recommended fourth version of the law includes increased fees to account in part for more post-approval safety oversight work, workload growth and escalating staff costs. A related fee-for-service item included in the request is aimed at collecting funds from companies requiring FDA review of direct-to-consumer advertising. (See BioWorld Today, Jan. 12, 2007.)

In his testimony, von Eschenbach said the package is "good for the American people," as well as for the FDA and the drug industry.

However, Enzi criticized him for failing to provide the committee with the agency's drug-review performance goals, which von Eschenbach said would be forthcoming within a few weeks. In addition, von Eschenbach said some of the funds generated through the enhanced user fees would boost the FDA's health insurance databases to mine for safety signals, a plan strongly supported during the hearing in testimony by former FDA commissioner Mark McClellan.

Of note, there was no talk of adding a proposal to allow follow-on biologics to the user fee and safety bills. Further PDUFA debate will continue through the spring, and a final version is expected to pass early this summer to give the FDA an appropriate cushion for calculating staff funding ahead of the next government fiscal year that begins Oct. 1.