FDAnews Drug Daily Bulletin

Senate Begins Discussions of PDUFA Reauthorization Bill

May 2, 2007

The Senate this week began debating the bill to reauthorize the Prescription Drug User Fee Act (PDUFA), a bill that has already undergone several changes since it was first introduced.

S.1082, introduced by Sen. Edward Kennedy (D-Mass.), establishes an overall amount of user fees of nearly $393 million for 2008, $30 million of which will be used to improve postapproval drug safety activities. A summary released by Kennedy’s office showed it has been amended since it was approved last week by the Senate Health, Education, Labor and Pensions (HELP) Committee. Sen. Mike Enzi (R-Wyo.) called the bill “a work in progress” and said decisions could be made up to the “last possible moment.” No votes on the bill were scheduled for Monday’s session of the Senate.

The most recent version of the bill reduces the minimum elements of a Risk Evaluation and Mitigation Strategies program, removing the requirement of 15-day, quarterly and annual reports of adverse events and routine active safety monitoring. In addition, the bill would include annual user fee increases for drug safety surveillance, including $25 million for routine surveillance. The bill’s previous version increased user fee revenue by $70 million for safety activities. 

The bill currently before the Senate also appears to address the controversy of what new authority to give the FDA over direct-to-consumer (DTC) ads. The original version of the bill had included a proposal to provide more user fees for a voluntary program where drug companies could submit DTC advertisements to the agency for review. In addition, the FDA could have stopped an advertisement’s distribution if it contained false or misleading claims.

During the committee deliberations last week, Sen. Pat Roberts (R-Kan.) said the DTC provision would violate companies’ right to free speech and that he would pursue the issue when the bill arrived on the Senate floor. PhRMA CEO Billy Tauzin also asked the Senate to reconsider the DTC legislation, because it would prevent patients from getting important information on treatment options.

The latest version of the bill would allow the FDA to ban DTC advertisements “in rare circumstances.” Kennedy said he would evaluate whether requiring expanded safety information in DTC advertisements and adding fines for misleading advertisements would achieve the goal of the ads providing accurate information.