Washington Editor

WASHINGTON - With Senate passage last week of a bill to authorize new safety powers at the FDA and renew the Prescription Drug User Fee Act, all eyes have shifted to the House of Representatives, which is expected to produce its own such legislation at a much slower clip.

Many details of that measure still are being worked out, said a staffer for Rep. John Dingell (D-Mich.), noting that he's focused on completing House action "in a timely" manner.

"We don't want to see PDUFA get bogged down," she told BioWorld Today, "but we don't know exactly what the legislation is going to look like."

Closed-door negotiations are continuing, and in addition to user-fee provisions, the bill also could include FDA safety authorities as well as language to establish an approval pathway for follow-on biologics. A safety-related bill that's been introduced in the House potentially is more restrictive for the drug industry than the language passed by the Senate, and at least two follow-on biologics bills are generating dialogue.

"Those things are still on the table; they're still part of the discussion," Dingell's staffer said.

The House Energy and Commerce Committee, which Dingell chairs, will hold "a couple more" PDUFA hearings this month to build on prior hearings, she said, with plans to advance marked up language out of committee "ideally" before the July 4 recess. That would set a time frame for a floor vote in the House sometime that month.

FDA officials have said they'd prefer that renewed user fees be signed into law no later than mid-July to avoid personnel disruptions at the agency, which would have to begin issuing reduction-in-force notices on July 31 because PDUFA sunsets Sept. 30.

Industry observers believe that the final legislative language to emerge from both chambers will represent the most significant change in FDA powers in a decade.

Lawmakers in the Senate on Wednesday reached a resolution on the "Food and Drug Administration Revitalization Act," or S. 1082, after days of debate, months of negotiations and, frankly, years of hearings on the FDA's functions. They passed the bill 93-1.

At its core are new safety regulations called "risk evaluation mitigation strategies" (REMS), guided largely by last fall's recommendations from the Institute of Medicine. Hailed as a flexible but effective safety program by S. 1082's primary sponsor, Sen. Edward Kennedy (D-Mass.), the system gives FDA the authority to impose REMS requirements when it deems necessary.

Those could include post-approval studies, special labeling and patient monitoring for certain drugs, among other things. And to give the agency some teeth in enforcing such a mandate, the lawmakers included an amendment to the bill to increase to $2 million the maximum monetary penalty that could be levied on drug companies for violating the terms of a REMS. In addition, active surveillance for every newly approved drug would make use of data from federal and private health databases.

S. 1082 also reauthorizes drug user fees for another five years, to about $393 million annually beginning next year, with a larger share of them to be dedicated to safety than ever before. Additional provisions give the FDA more power to make quicker label changes; create a public database of all clinical trials and their results; limit drug advertising to some degree; put a three-month cap on exclusivity for blockbuster products studied in children as part of renewing two pediatric drug laws scheduled to sunset this year; renew medical device user fees; and tighten conflict-of-interest disclosure rules for FDA advisory committee members.

A rejected amendment would have much more strictly limited such panel participation, and another rejected amendment would have separated the FDA's safety office from its drug-review division.

An amendment that was accepted, to add prescription drug importation language to S. 1082, effectively was neutered when lawmakers also agreed to a second-degree amendment to require the Department of Health and Human Services to certify that imported drugs pose no additional safety risks and result in significant savings.

Kennedy, chairman of the Health, Education, Labor and Pensions Committee from which FDA-related bills such as S. 1082 arise, has said that follow-on language would be entered in a conference to merge the bill with the House's version.

Of course, because Dingell's staffer said the House is "doing it in a different way" by separately addressing the laws scheduled to sunset this year, it remains a bit unclear as to how the conference would proceed.