Challenges for the FDA The Future of Drug Safety: Workshop Summary (2007) / Chapter Skim
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9 Looking to the Future
9 Looking to the Future
Pages 70-77
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From page 70... ...
In her presentation, for example, Myrl Weinberg, President, National Health Council, stressed the urgent need for Congress to reauthorize PDUFA and increase appropriations to ensure that the FDA is adequately resourced to monitor drug safety. It is also important for Congress to support the FDA's Critical Path 0
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From page 71... ...
For example, with respect to using potential biomarkers to define risks and benefits in databases, it should be possible to collaborate with large health care organizations that routinely capture at least some of this information. According to Dr.
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From page 72... ...
Patients and the public need to understand that generally, detection of safety problems in premarket studies is limited to common adverse events occurring after a relatively short-term exposure and brief period of follow-up. These studies are not adequately powered to detect rare adverse events; therefore, postmarket surveillance is necessary to identify additional safety issues.
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From page 73... ...
She asserted that the system needs to do a better job of putting the patient's needs first. There must be a balance between access to drugs that help individuals lead independent, productive lives and attention to safety concerns, with the risks and benefits of prescription drugs being carefully weighed "in full public view." THE FUTURE OF DRUG SAFETY REGULATION Dr.
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From page 74... ...
Second is the idea that profiling and managing the risks and benefits of a drug should be a continuous learning process, one that employs a systematic life-cycle approach in which potential areas of concern requiring postmarket evaluation are identified during the premarket process. The view was widely expressed that there are at least two necessary next steps for achieving these goals: • Provide the FDA with additional resources to support its Critical Path Initiative and related efforts aimed at improving drug safety.
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From page 75... ...
A better infrastructure for understanding risks and safety signals and other aspects of drug utilization would enable more effective targeting of costly followup clinical studies. Several steps must be taken to develop a populationbased approach, some of which the FDA has announced and others of which will require additional resources: • FDA initiatives that have already been announced include enhanced tracking and follow-up of postmarket issues, planned improvements in AERS, and pilots of new postmarket drug-monitoring strategies.
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From page 76... ...
strategy on a pilot basis and does not anticipate that implementing this strategy would require additional authority beyond the usual monitoring performed by the agency. • Congress is in the midst of a legislative debate on this topic, and further legislative action is likely that will provide the FDA with more powerful tools encompassing additional enforcement responses.
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From page 77... ...
• There are a number of other opportunities for such public–private collaboration to achieve consensus on how to move forward. These include improving safety science; developing better postmarket evidence on the risks and the actual use of drugs; developing more individualized and effective benefit–risk communications; assessing the development and use of new regulatory tools; and ultimately, continuing to improve the regulatory system while avoiding unnecessary costs and delays in access, creating a health care system that delivers the best possible treatment to each patient.
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