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Ethical and Scientific Issues in Studying the Safety of Approved Drugs (2012) / Chapter Skim
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Appendix A: Other Elements of the Food and Drug Administration Amendments Act
Pages 227-230

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From page 227...
... ability to take a lifecycle approach to drug oversight: the authority to require postmarketing studies; the authority to require risk evaluation and mitigation strategies; and the requirement to develop a large-scale active surveillance system. This appendix discusses additional sections of FDAAA that improve FDA's ability to oversee drugs in the postmarketing setting: increased authority to enforce submission of clinical-trial registry and database information; increased authority over the contents of direct-to-consumer advertising; increased authority to order labeling and warning changes in a timely manner; increased resources directed toward identifying and mitigating drug risks both premarketing and postmarketing; and increased requirements for agency transparency and risk communication.
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From page 228...
... FDAAA also increased FDA's regulatory responsibility for the form of and methods for reporting serious adverse events in ClinicalTrials.gov.8 CONTENTS OF DIRECT-TO-CONSUMER ADVERTISING FDAAA provides FDA with the authority to require that direct-to-consumer radio and television advertisements include a "major statement relating to side effects and contraindications" of the drug and that the "major statement" be "presented in a clear, conspicuous, and neutral manner".9 FDAAA stipulates that in the absence of such a statement, FDA can determine that the advertisement is "false or misleading",10 and establishes civil penalties for dissemination of such advertisements.11 On March 29, 2010, FDA published in the Federal Register the following proposed standards for evaluating a "major statement": • Information is presented in language that is readily understandable by consumers. • Audio information is understandable in terms of the volume, articulation, and pacing used.
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From page 229...
... Those changes can include "boxed warnings, contraindications, warnings, precautions, or adverse reactions".14 INCREASED RESOURCES FOR DRUG SAFETY In addition to increasing FDA's postmarketing responsibility and authority, FDAAA specifies that user fees will be "dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarketing drug safety activities".15 Much of the funding comes from a specific authorization of $225 million over 5 years for "drug safety".16 The funds are being used by the Center for Drug Evaluation and Review (CDER) and others in FDA to increase the number of staff dedicated to the safety evaluation of marketed medications and to administer CDER's new safety-related authority under FDAAA, including the implementation of REMSs, postmarketing require ments (PMRs)
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From page 230...
... now includes information on new package inserts and labels, recent safety informa tion and alerts, quarterly reports on potential safety issues identified by using the Adverse Event Reporting System database, and links to other FDA-approved safety information. FDA has recently taken advantage of new technology by making electronic subscriptions available to MedWatch via e-newsletters, safety alerts, and Twitter (FDA, 2012)
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  • postmarketing studies
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  • require risk

  • proposed standards
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