Challenges for the FDA The Future of Drug Safety: Workshop Summary (2007) / Chapter Skim
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8 Enhancing Postmarket Regulation and Enforcement
8 Enhancing Postmarket Regulation and Enforcement
Pages 58-69
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From page 58... ...
Recommendation 5.2 The committee recommends that Congress provide oversight and enact any needed legislation to ensure compliance by both the Food and Drug Administration and drug sponsors with the provisions listed above. FDA needs increased enforcement authority and better enforcement tools directed at drug sponsors, which should include fines, injunctions, and withdrawal of drug approval.
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From page 59... ...
This variation in the application of the FDA's authority led to the call in the IOM report for clarifying and strengthening the agency's existing authority to regulate marketed drugs, and for giving the FDA sufficient enforcement tools to ensure that regulatory requirements imposed at or after approval are fulfilled (see the recommendations listed above)
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From page 60... ...
Preapproval trials frequently will not detect drug risks that are the result of drug interactions or variations in risk across the general population. The IOM report argued that enhanced postmarket authority would take some of the pressure off the preapproval process.
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From page 61... ...
Formal mechanisms include seizure, injunction, and criminal action, the latter representing one of only two statutes in U.S. history that imposes criminal liability on corporate officials regardless of whether they had knowledge of or intent to commit a crime.
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From page 62... ...
While this failure has been attributed to faster drug approvals, she argued that the Prescription Drug User Fee Act (PDUFA) did not accelerate review and approval as much as it redressed unwarranted delays.
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From page 63... ...
Hutt argued that the FDA does not need statutory authority to regulate Phase IV studies. Rather, he suggested that there be a mechanism for reviewing postmarket Phase IV commitments to ensure that studies are well designed and executable, either before or after approval, and that the FDA follow up with a later review in the event a company claims it cannot gain IRB approval or enroll enough patients.
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From page 64... ...
Mr. Hutt responded that while the new statute requires the FDA to act accordingly, the agency could have implemented this process without further statutory authority -- as is the case for many of the safety initiatives described during the symposium.
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From page 65... ...
ENHANCING POSTMARKET REGULATION AND ENFORCEMENT importance of realizing what implementation of some of the IOM report's recommendations addressing postmarket compliance will cost in terms of both resources and time. An example is the amount of effort required to address the current backlog of postmarket commitments.
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From page 66... ...
approval as overdue, including reports that may have been submitted on a modified reporting schedule in accordance with prior FDA agreement. Of the applications categorized as having overdue annual reports using this definition, annual reports were subsequently submitted in fiscal year 2006 for 133/133 (100%)
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From page 67... ...
Slater, the FDA has the will but not the funding to do the same. Advertising or marketing of a drug falls within the purview of drug labeling; therefore, the FDA's mandate does not include approving advertising and promotional materials beyond the labeling negotiations that occur prior to approval.
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From page 68... ...
Moreover, the responsibility for drug safety does not end at approval, but demands continuing assessment and improvement of the benefit–risk profile throughout a product's lifetime. Effective continuing assessment, in turn, requires partnerships across the health care spectrum.
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From page 69... ...
Haffner emphasized that this must be done with care and only under rare circumstances. The IOM report recommended that the FDA have increased authority to restrict drug distribution (Recommendation 5.1)
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