goals that drive CDER’s work, whether or not associated with PDUFA funding. Introducing new safety goals would be consistent with the lifecycle approach to regulation.

The committee offers a series of suggested goals to assist CDER in thinking about ways to couple accountability for timeliness and safety. Such goals will ideally be quantifiable. Whether or not PDUFA is reauthorized the committee believes it is important to measure and report on achieving safety goals.

3.5: To restore appropriate balance between the FDA’s dual goals of speeding access to innovative drugs and ensuring drug safety over the product’s lifecycle, the committee recommends that Congress should introduce specific safety-related performance goals in the Prescription Drug User Fee Act IV in 2007.

Those goals, independent of funding source, could include the following (organized topically):

Expertise in preapproval evaluation:

  • Target participation rate for ODS/OSE staff involvement in drug review teams: for priority original NDA and biologic license application submissions 60 percent year 1, 70 percent year 2, 80 percent year 3, 90 percent year 4, and 100 percent year 5; for standard original NDA and BLA submissions 40 percent year 1, 50 percent year 2, 60 percent year 3, 70 percent year 4, and 80 percent year 5.

  • Report annually to Congress on the number of new molecular entities (NMEs) for which data were evaluated by external advisory committees, and the proportion of all NME NDAs that that number represents.

Monitoring of adverse drug reactions and Adverse Event Reporting System (AERS):

  • Prepare a summary analysis of the adverse drug reaction reports received for a newly approved drug, which identifies any new risks not previously identified, potential new risks, or known risks reported in unusual number not previously identified within 18 months of drug launch or after exposure of 10,000 persons, whichever is later. Reports should be publicly available and posted on the agency’s Web site.

  • Conduct regular (biweekly) screening of the AERS database, especially 15-day reports, to identify new safety signals.

  • Ensure that public access to AERS reports is updated every 6 months.

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