Postmarketing study commitments:

  • Review the entire backlog of postmarketing commitments to determine which commitments require revision or should be eliminated and report to Congress on these determinations. Of commitments that remain, those without start dates should have start dates associated with them to prevent perpetual “pending” status (12 months from PDUFA IV initiation) (also see Chapter 5 for a discussion of postmarketing, or Phase IV, commitments).

  • Report completion rates (by company) for (i) postmarketing studies requested prior to approval and (ii) postmarketing studies requested when a drug is already on the market and the number of delinquent studies (past the original projected completion date) in each category.

  • Report on enforcement actions taken to ensure timely completion of postmarketing study commitments (for commitments that are currently required, such as those associated with accelerated approval, and for other commitments FDA will be able to require and enforce after implementation of recommendations made in Chapter 5).

  • Review and propose action, if warranted, on completed postmarketing studies (within 60 days from submission of the study for actions deemed urgent, 120 days for less urgent actions).

Postmarketing risk communication activities and risk management:

  • In the annual PDUFA performance report to Congress, include the timeliness of implementing regulatory actions10 (from the date of the agency’s initial proposed action to the date of the actual labeling change) and the number of such changes.

  • In the annual PDUFA performance report to Congress, include the number of patient information sheets developed for new drugs and the proportion of new drugs approved in that year for which patient information sheets are developed. (The committee recognizes that DrugWatch and other activities of the Drug Safety Oversight Board are still under development. The final outcome could affect the relevance and usefulness of this suggestion.)

  • Review an applicant’s implementation of risk management plans and make the report available on the agency’s Web site.

  • Review and act on drug advertisements and promotional materials submitted to the agency (within 90 days in year 1, 60 days in year 2, 30 days in year 3 and beyond).

10

Including labeling changes, black boxes, and measures leading to drug withdrawal (see Chapter 5 for discussion and recommendations on strengthening FDA’s authority).



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