12:00 AM
Apr 23, 2007
 |  BioCentury  |  Politics, Policy & Law

Great unknowns

PDUFA reauthorization passed a major milestone last week when the U.S. Senate's expert committee voted 15-5 in favor of a bill that extends drug and device user fees for five years and revamps drug safety oversight. But the final shape and impact of the legislation is still not clear.

PDUFA IV and associated legislation will certainly move the U.S. into an era of total lifecycle regulation for prescription drugs, and newly inserted provisions promise to increase the transparency of FDA deliberations.

The most important unknowns in the PDUFA IV equation are the balance Congress will strike between precautionary and data-driven safety regulation, and whether the myriad statutory changes will work as intended or if they will end up unnecessarily delaying the development and review of new drugs.

At this point, both FDA and industry believe that without substantial revisions, the Food and Drug Administration Revitalization Act (S. 1082) would gum up the regulatory machinery, creating counterproductive hurdles to developing new drugs.

S. 1082 "is overly onerous in terms of process and structural changes and could actually have the unintended effect of slowing down drug approvals - while doing little to address the core issues of drug safety," according to a letter from HHS Secretary Michael Leavitt to Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Sen. Edward Kennedy (D-Mass.).

Marking the differences

Leavitt's April 17 letter was delivered a day before the HELP Committee held a "markup" session on S. 1082 and voted to send the bill to the full Senate.

During the session, Kennedy noted S. 1082 had been modified in response to comments from stakeholders and that staff will continue to refine it prior to a full Senate vote. Still, the bill's drug safety approach remains the same, formalizing the process of identifying risks prior to approval and giving FDA new authority to manage them.

In a concession to patient groups, Kennedy and the bill's co-author, Sen. Michael Enzi (R-Wyo.), dropped the requirement that...

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