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Suggested Citation:"6 Next Steps." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
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6
Next Steps

Over the course of the workshop, participants generally agreed on several themes or points that are important to consider in improving our understanding of benefits and risks of pharmaceuticals:

  • It is important in pharmaceutical benefit–risk analysis to provide patients and physicians with the best possible information for making informed decisions about the use of pharmaceuticals.

  • It is important to employ quantitative and standardized approaches when trying to evaluate pharmaceutical benefit–risk. These approaches should augment rather than replace current regulatory approaches to pharmaceutical approval and labeling. More work needs to be done to develop and validate such tools.

  • It is important to educate patients and physicians about the concepts of pharmaceutical benefit–risk and how these are assessed throughout the life cycle of a drug.

  • It is important to develop and validate improved tools for communicating pharmaceutical benefit–risk information to patients and physicians.

  • It is important to involve patients and physicians in the development of new tools for evaluating and communicating data concerning pharmaceutical benefit–risk.

  • It is important to improve the current system for collecting post-marketing safety and efficacy data on marketed pharmaceuticals.

Suggested Citation:"6 Next Steps." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
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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.

Suggested Citation:"6 Next Steps." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
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Page 59
Suggested Citation:"6 Next Steps." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
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Page 60
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All pharmaceutical products have inherent risks, and their use involves trade-offs between their therapeutic benefits and their risks. However, the public has a limited understanding of the benefits and risks of drugs, and many individuals believe that drugs approved by the U.S. Food and Drug Administration (FDA) carry no risks. The FDA is responsible for evaluating and balancing the potential risks of drugs with their potential benefits. Assessing, managing, and communicating the benefit-risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge. Once the assessment is made, the FDA is then responsible for managing how to communicate these risks and make healthcare decisions based on them.

To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system used to evaluate benefit and risk, and to identify opportunities for improvement. This workshop was held in Washington, D.C., on May 30-31, 2006. The benefit-risk profiles of pharmaceuticals are constantly evolving as new data are collected throughout the life cycle of a drug. Discussions during the workshop focused on the following: (1) premarket assessment, during which clinical trial data are used to assess benefit and risk; (2) communication of that information to prescribing physicians and their patients; (3) healthcare decisions made by prescribing physicians and their patients; and (4) the accumulation of benefit-risk information from postmarketing experience, which feeds back into the other phases. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary explains in detail the discussions during this workshop.

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