Source: http://books.nap.edu/openbook.php?record_id=13219&page=228
Timestamp: 2015-07-30 14:18:26
Document Index: 129321885

Matched Legal Cases: ['§ 282', '§ 282', '§ 282', '§ 282', '§ 282', '§ 282', '§ 352', '§ 352', '§ 352', '§ 202']

Front Matter R1-R16 Abstract 1-2 Summary 3-28 1 Introduction 29-60 2 Incorporating Benefit and Risk Assessment and BenefitRisk Management into Food and Drug Administration Decision-Making 61-120 3 Evidence and Decision-Making 121-168 4 Selection and Oversight of Required Postmarketing Studies 169-212 5 Synthesis 213-226 Appendix A: Other Elements of the Food and Drug Administration Amendments Act 227-230 Appendix B: Committee's Letter Report 231-250 Appendix C: Open Session Agendas 251-254 Appendix D: Decision Conferencing and Multicriteria Decision Analysis 255-260 Appendix E: Benefit and Risk Assessment and Management Plan Document Template 261-268 Appendix F: Committee Biosketches 269-276 ClinicalTrials.gov; there was no enforcement capability to ensure that privately funded trials were included, and study results were not included in the database.3 FDAAA expanded the requirements for registration of clinical trials to include all trials beyond Phase 1 that are parts of new drug applications,4 required the reporting of results of those trials,5 and gave FDA the ability to enforce registration by allowing penalties if drug sponsors failed to comply with submission of information to ClinicalTrials.gov.6 The statute directs NIH to ensure that the information submitted is truthful and not misleading.7 Sponsors must submit any changes in the information to NIH. FDAAA also increased FDA’s regulatory responsibility for the form of and methods for reporting serious adverse events in ClinicalTrials.gov.8
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.
• Textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and font style that can be read easily; and there are no distractions—such as statements, text, images or sounds—that detract from the communication of the major statement.12
342 USC § 282(i) (2010).
442 USC § 282(j)(1)(A) (2010).
542 USC § 282(j)(3) (2010).
642 USC § 282(j)(5)(E) (2010).
742 USC § 282(j)(5)(D) (2010).
842 USC § 282(j)(3)(I) (2010).
921 USC § 352(n) (2010).
1021 USC § 352(q) (2010).
1121 USC § 352(r) (2010).
12Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner, 75 Fed. Reg. 15376-15387 (March 29, 2010) (amending 20 CFR § 202.1).
Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs, Institute of Medicine "Appendix A: Other Elements of the Food and Drug Administration Amendments Act."