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www.fdanews.com/articles/63469-enzi-may-hold-hearings-before-markup-of-drug-safety-bill

ENZI MAY HOLD HEARINGS BEFORE MARKUP OF DRUG SAFETY BILL

October 24, 2006

Health, Education, Labor and Pensions (HELP) Committee Chairman Sen. Mike Enzi (R-Wyo.) is readying to make another push for his drug safety bill when Congress returns after the November elections, a staffer on the majority HELP staff said.

Enzi is even willing to hold a hearing on drug safety issues to help move the bill out of committee and to the full Senate, as long as there is enough time in the lame duck session, the source said. The hearing would address a recent National Academies' Institute of Medicine (IOM) report on drug safety.

Democrats on the HELP committee had requested that Enzi delay a markup of his bill, S. 3807, the "Enhancing Drug Safety and Innovation Act," until the committee had a chance to review the report. The IOM report recommended that Congress give the FDA the authority to require whatever postmarketing risk assessment and risk management programs are needed to monitor and ensure the safe use of drug products.

While the senator does not believe there is time enough to pass his bill during the lame duck session, he wants to get a "head start" on passing the legislation next session, the source said. The staffer was skeptical of Democrats' motives, however, saying that sometimes a call for hearings is "just a delay tactic."

While there is a chance that Democrats might take the Senate in the midterm elections, that will not affect the bill's prospects, the source added. The bill has bipartisan support and was co-sponsored by the committee's ranking member, Sen. Edward Kennedy (D-Mass.), who would likely chair the committee in a Democrat-controlled Senate. Both senators "have the swing votes together" to ensure that the bill makes it out of committee, the source said.

(http://www.fdanews.com/did/5_208/)