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Senate HELP Committee Approves Revised PDUFA Bill
By Martin Gidron
Drug Industry Daily
April 19, 2007
A Senate committee passed a revised version of a bill that would provide more user fees to the FDA to increase drug safety and transparency in the agency. However, opponents of the bill plan to continue their fight on the Senate floor.
S.1082, the "Food and Drug Administration Revitalization Act," would reauthorize the Prescription Drug User Fee Act, increasing more user fees by nearly $30 million to improve postapproval drug safety activities. The Senate Health, Education, Labor and Pensions (HELP) Committee passed the bill by a vote of 15-5.
The bill's opponents said they had not had enough time to review the bill and prepare their amendments. "Even though we asked to be involved, we weren't," Sen. Judd Gregg (R-N.H.), who proposed an amendment on the agency's clinical trial data collection process, said.
"My ideas weren't heard in meetings leading up to this," Sen. Tom Coburn (R-Okla.) added, saying his staff did not receive an updated version of the bill's text until very late at night.
However, a spokeswoman for HELP Committee ranking member Mike Enzi (R-Wyo.) said other senators were "never shut out of negotiations" and added the committee staff had held several meetings to discuss the bill since February.
The spokeswoman acknowledged that the proposed bill is very long, at 262 pages, and that staff members got the final version the night before the deadline for filing amendments. However, none of the bill's contents should have been a surprise because of all the meetings, she added.
Several proposed amendments dealt with the bill's risk evaluation and mitigation Strategies (REMS) process, where products would have risk plans that include 15-day, quarterly and annual adverse event reports. The products would also need a pharmacovigilance statement explaining and justifying whether standard adverse event reporting is adequate, or if more studies and clinical trials are necessary.
Gregg's amendment, which was defeated, would have required the FDA to send information suggesting a drug increased the risk of adverse events to an outside institution for review.
His amendment found support from other Republican senators, including Coburn, who said the REMS program in S.1082 would only make the FDA aware of problems after they happened, not before. Coburn added that the REMS program could allow the approval of another drug like Vioxx, which was pulled from the market after studies showed it increased the risk of heart attack and stroke.
Other lawmakers took issue with the bill's provisions on direct-to-consumer (DTC) advertising. The bill includes a proposal to provide more fees for a voluntary program where drug companies can submit advertisements to the FDA for review.
The bill would also allow the FDA to stop an advertisement's distribution if it advertisement contains false or misleading claims. Sen. Pat Roberts (R-Kan.) suggested that restriciton would violate companies' right to free speech. "These provisions fly right in the face of the Constitution," he said. Although his amendment to limit the FDA's authority was defeated, Roberts said he would continue to pursue the issue if the bill came to a full Senate vote.
The committee also had a working group to discuss adding legislation to include an approval pathway for follow-on biologics, but that issue did not make it onto the markup version of the bill. Sen. Hillary Rodham Clinton (D-N.Y.) said she was "disappointed" the bill did not include the legislation for follow-on biologics and called on the committee to add it.
Several groups, including Consumers Union, Public Citizen and the Generic Pharmaceutical Association also asked the committee to pass follow-on biologic pathway legislation. It is still possible that such legislation could be attached to the bill by the time it reaches the Senate floor, the spokeswoman for Enzi said.
Enzi called for the bill to be passed by the end of July. At a House subcommittee hearing April 17, the FDA requested the approval of PDUFA by late June or early July (DID, April 18).
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