The workshop concluded with a discussion of possible next steps. Several suggestions were put forth:

  • Develop an eight- to ten-page bulleted summary of facts and assumptions about pharmaceutical risk and benefit that the IOM or the Forum could use to educate legislators and others. This could also be posted on the web for physicians and patients.

  • Design one or more pilot studies with the FDA to address some of the suggestions and considerations voiced at this meeting—for example, a study on utility-based analysis of benefit–risk for either an existing drug or a drug that is under FDA consideration. A second pilot could test the utility of one or more new patient–physician communication tools such as the Prescription Drug Facts Box. Adopting an experimental attitude would be a way to move forward several of the specific initiatives suggested by meeting participants.

  • Plan follow-up meetings that focus on specific problems. For example, one meeting could address novel approaches to postmarketing surveillance and the limits of AERS, another might compare different quantitative tools for evaluating drug benefit–risk, and a third might address risk management plans and whether and how they should be submitted at the time of a new drug application.

  • Encourage patient and physician involvement in future discussions.

  • Incorporate pharmaceutical pricing in the discussion of benefit– risk analysis because, at least for legislators, cost is a critical element of the discussion.

  • Avoid assigning blame among the various stakeholders involved in benefit–risk assessment because it damages public trust.

  • Consider instituting citizen councils, as the United Kingdom’s National Institute for Clinical Excellence did when faced with a similar crisis in public trust. Decisions to be made by the FDA regarding benefit– risk assessment could be laid out for the councils, who would then be asked how they value the options. Not only would this tactic add legitimacy to the decisions being made, council members could become champions for those decisions—and “the state of the science”—in the larger community.

Several participants suggested that there is a need for urgency in addressing these steps because of the imminent reauthorization of the Prescription Drug User Fee Act (PDUFA) and the possible enactment other potential drug safety bills.



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