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Ethical and Scientific Issues in Studying the Safety of Approved Drugs (2012) / Chapter Skim
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Appendix E: Benefit and Risk Assessment and Management Plan Document Template
Pages 261-268

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From page 261...
... By contrast, a key aspect of the recommendation for a BRAMP document is that it will be a single, easy to read, living document that is updated at periodic intervals, includ ing whenever the benefit–risk profile of a drug is questioned or evaluated in the postmarketing setting, and therefore that will serve as a comprehensive source of information about a drug. This BRAMP template is for a fictitious Drug X, approved by Food and Drug Administration (FDA)
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From page 262...
... At the time of approval for marketing, the public health question is whether the benefits of Drug X outweigh its risks and, therefore, whether the drug should be approved for marketing. This section also should include a discussion of the context in which the public health question is asked.
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From page 263...
... 3. Regulatory Actions and Rationale This section should have a clear statement of the regulatory decision, and the rationale for that decision, including not only the final output of the benefit–risk assessment process but a description of any other factors that affected the deci sion, such as ethical issues, timeframe issues, the lack of an available treatment for a disease, or the risk posed by a drug in a specific population.
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From page 264...
... It should outline the public health question that prompted the label change, summarize the benefit and risk assessment that supported the change, and outline the regulatory change.
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From page 265...
... SECTION 3 REQUIREMENT OF A REMS 05/21/2009 This section of the document should contain a discussion of the decision to require a REMS for Drug X It should outline the public health question that prompted consideration of the REMS requirement, summarize the benefit and risk assessment that supported the requirement, and outline the regulatory requirement.
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From page 266...
... It should outline the public health question that prompted consideration of removal of the REMS require ment, summarize the benefit and risk assessment that supported the change, and outline the regulatory change.
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From page 267...
... b. Rationale This section should discuss the rationale for the regulatory decision, includ ing a description of any factors other than the benefit and risk assessment that might have affected the decision, such as ethical issues, patient perspectives, timeframe issues, the lack of an available treatment for a disease, and the risk posed by the drug in a specific population.
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