The Future of Drug Safety Promoting and Protecting the Health of the Public (2007) / Chapter Skim
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at the FDA must weigh the information available about a drug's risk and benefit, make decisions in the context of scientific uncertainty, and integrate emerging information bearing on a drug's risk-benefit profile throughout the lifecycle of a drug, from drug discovery to the end of its useful life. These processes may have life-or-death consequences for individual patients, and for drugs that are widely used, they may also affect entire segments of the population.
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Thus, the understanding of a drug's risk-benefit profile necessarily evolves over the drug's lifecycle. CDER staff who review regulatory submissions, such as new drug applications, must strike a delicate balance in judging the drug's risks and benefits, and whether the need for more study to increase certainty before approval warrants delaying the release of the drug into the marketplace and into the hands of health care providers and their patients.
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As part of its work, the IOM committee will: • examine the FDA's current role and the role of other actors (e.g., health professionals, hospitals, patients, other public agencies) in ensuring drug safety as part of the US health care delivery system; • examine the current efforts for the ongoing safety evaluation of marketed drug products at the FDA and by the pharmaceutical industry, the medical community, and public health authorities; • evaluate the analytical and methodological tools employed by FDA to identify and manage drug safety problems and make recommendations for enhancement; • evaluate FDA's internal organizational structure and operations around drug safety (including continuing postmarket assessment of risk vs.
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Third, the committee found that the drug safety system is impaired by the following factors: serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety; an organizational culture in CDER that is not optimally functional; and unclear and insufficient regulatory authorities particularly with respect to enforcement. Fourth, the committee found that FDA, contrary to its public health mission, and the pharmaceutical industry, contrary to its responsibility to the users of its products (and its shareholders)
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For the health care delivery system, a lifecycle approach to risk and benefit implies the need to heed and follow FDA communication about drug safety matters and to exercise appropriate caution in drug-related decision making (from formularies to prescribing) in recognition of the limited information available at the time of drug approval.
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, has not had a formal role in drug regulation -- neither formal opportunities to learn from and participate in relevant aspects of the review process nor the authority to take action regarding postmarketing safety. 3.4: The committee recommends that CDER appoint an OSE staff member to each New Drug Application review team and assign joint authority to OND and OSE for postapproval regulatory ac tions related to safety.
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increase their intramural and extramural programs that access and study data from large automated healthcare databases and (b) include in these programs studies on drug utilization patterns and background incidence rates for adverse events of interest, and (c)
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With this expanded expertise and resources CDER can be a more effective steward of postmarketing safety and a more credible scientific partner with industry and academia by actively participating in defining important research questions and designing appropriate studies. 4.6: The committee recommends that CDER build internal epide miologic and informatics capacity in order to improve the postmar ket assessment of drugs.
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4.8: The committee recommends that FDA have its advisory com mittees review all NMEs either prior to approval or soon after ap proval to advise in the process of ensuring drug safety and efficacy or managing drug risks. 4.9: The committee recommends that all FDA drug product ad visory committees, and any other peer-review effort such as men tioned above for CDER-reviewed product safety, include a pharma coepidemiologist or an individual with comparable public health expertise in studying the safety of medical products.
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4:13: The committee recommends that the CDER review teams regularly and systematically analyze all postmarket study results and make public their assessment of the significance of the results with regard to the integration of risk and benefit information. Regulation FDA lacks the clear, unambiguous authority needed to enforce sponsor compliance with regulatory requirements and instead relies on the prospect of productive negotiations with industry.
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5.1: The committee recommends that Congress ensure that the Food and Drug Administration has the ability to require such postmarketing risk assessment and risk management programs as are needed to monitor and ensure safe use of drug products. These conditions may be imposed both before and after approval of a new drug, new indication, or new dosage, as well as after identifi cation of new contraindications or patterns of adverse events.
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Sponsors will submit a report of accumulated data relevant to drug safety and efficacy, including any additional data published in a peer-reviewed journal, and will report on the status of any applicable conditions imposed on the distribution of the drug called for at or after the time of approval. Communication The public would benefit from more information about how drugs are studied before FDA approval, how drugs' risks and benefits are assessed, and what FDA review entails.
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This preference is based on the expectation that CDER will continue to review and approve drugs in a timely manner and that increasing attention to drug safety will not occur at the expense of efficacy reviews but rather it will complement efficacy review for a lifecycle approach to drugs. Congressional appropriations from general tax revenues are a mechanism by which the public can directly, fairly, and effectively invest in the FDA's postmarket drug safety activities.
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2005. NEWS -- IOM Panel Urged to Immediately Recommend that Con gress Toughen Drug Safety Laws to Sae Lies: Consumers Union Testifies Today That Obious Safety Problems Need Action Now.
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