ENZI'S DRUG SAFETY STRATEGY TO FOCUS ON STAFF NEGOTIATIONS

Sen. Mike Enzi (R-Wyo.), chairman of the committee with jurisdiction over the FDA, will focus more on staff-level negotiations instead of public hearings to pass prescription drug safety legislation during the second session of the 109th Congress.

While Enzi, the chairman of the Senate Health Education, Labor and Pensions (HELP) Committee, did not mention drug safety in his 2006 committee agenda, he will continue to push the issue, albeit through behind-the-scenes negotiations, said HELP spokesman Craig Orfield. Drug safety was mentioned prominently in Enzi's previous agenda, followed by three hearings to discuss the issue.

The legislative priorities listed in Enzi's HELP agenda -- such as bioterrorism and increased health insurance options for small businesses -- still require public hearings to get the support necessary to pass legislation, said Orfield. However, congressional discussions on drug safety are farther along and need no additional hearings, he told FDAnews.

Instead, staff members for both Enzi and Sen. Edward Kennedy (D-Mass.), the ranking Democrat on the committee, are now negotiating the content of a drug safety bill. "You will ultimately see a bill offered," said Orfield, who declined to say when it would be introduced. The chairman is focusing on a bill that ensures drug safety while preventing unnecessary delays in approving new drugs, he added.

Enzi and Kennedy hope to strike a balance between these twin goals. They "don't want to tip the scales one way or another," said Orfield. The chairman will soon introduce a bill that "re-establishes a balance between sound science and safety that can provide safe products to consumers as efficiently as possible," he said.

Lawmakers on both sides of the aisle have been clamoring for stronger drug safety laws following the recent discoveries of adverse cardiovascular events related to the use of Cox-2 inhibitors and links between antidepressant use and suicidal behavior in children.