121 STAT. 944 Deadline. Reports.
PUBLIC LAW 110–85—SEPT. 27, 2007
SEC. 904. BENEFIT-RISK ASSESSMENTS.
Not later than 1 year after the date of the enactment of this Act, the Commissioner of Food and Drugs shall submit to the Congress a report on how best to communicate to the public the risks and benefits of new drugs and the role of the risk evaluation and mitigation strategy in assessing such risks and benefits. As part of such study, the Commissioner may consider the possibility of including in the labeling and any direct-to-consumer advertisements of a newly approved drug or indication a unique symbol indicating the newly approved status of the drug or indication for a period after approval. SEC. 905. ACTIVE POSTMARKET RISK IDENTIFICATION AND ANALYSIS.
dkrause on GSDDPC44 with PUBLAW
VerDate Aug 31 2005
13:52 Jan 23, 2009
(a) IN GENERAL.—Subsection (k) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following: ‘‘(3) ACTIVE POSTMARKET RISK IDENTIFICATION.— ‘‘(A) DEFINITION.—In this paragraph, the term ‘data’ refers to information with respect to a drug approved under this section or under section 351 of the Public Health Service Act, including claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, and any other data deemed appropriate by the Secretary. ‘‘(B) DEVELOPMENT OF POSTMARKET RISK IDENTIFICATION AND ANALYSIS METHODS.—The Secretary shall, not later than 2 years after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, in collaboration with public, academic, and private entities— ‘‘(i) develop methods to obtain access to disparate data sources including the data sources specified in subparagraph (C); ‘‘(ii) develop validated methods for the establishment of a postmarket risk identification and analysis system to link and analyze safety data from multiple sources, with the goals of including, in aggregate— ‘‘(I) at least 25,000,000 patients by July 1, 2010; and ‘‘(II) at least 100,000,000 patients by July 1, 2012; and ‘‘(iii) convene a committee of experts, including individuals who are recognized in the field of protecting data privacy and security, to make recommendations to the Secretary on the development of tools and methods for the ethical and scientific uses for, and communication of, postmarketing data specified under subparagraph (C), including recommendations on the development of effective research methods for the study of drug safety questions. ‘‘(C) ESTABLISHMENT OF THE POSTMARKET RISK IDENTIFICATION AND ANALYSIS SYSTEM.— ‘‘(i) IN GENERAL.—The Secretary shall, not later than 1 year after the development of the risk identification and analysis methods under subparagraph (B), establish and maintain procedures—