PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 961
did not refer the drug to an advisory committee prior to approval.’’. SEC. 919. RESPONSE TO THE INSTITUTE OF MEDICINE.
(a) IN GENERAL.—Not later than 1 year after the date of the enactment of this title, the Secretary shall issue a report responding to the 2006 report of the Institute of Medicine entitled ‘‘The Future of Drug Safety—Promoting and Protecting the Health of the Public’’. (b) CONTENT OF REPORT.—The report issued by the Secretary under subsection (a) shall include— (1) an update on the implementation by the Food and Drug Administration of its plan to respond to the Institute of Medicine report described under such subsection; and (2) an assessment of how the Food and Drug Administration has implemented— (A) the recommendations described in such Institute of Medicine report; and (B) the requirement under section 505–1(c)(2) of the Federal Food, Drug, and Cosmetic Act (as added by this title), that the appropriate office responsible for reviewing a drug and the office responsible for postapproval safety with respect to the drug work together to assess, implement, and ensure compliance with the requirements of such section 505–1.
SEC. 920. DATABASE FOR AUTHORIZED GENERIC DRUGS.
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Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by section 918, is further amended by adding at the end the following: ‘‘(t) DATABASE FOR AUTHORIZED GENERIC DRUGS.— ‘‘(1) IN GENERAL.— ‘‘(A) PUBLICATION.—The Commissioner shall— ‘‘(i) not later than 9 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, publish a complete list on the Internet Web site of the Food and Drug Administration of all authorized generic drugs (including drug trade name, brand company manufacturer, and the date the authorized generic drug entered the market); and ‘‘(ii) update the list quarterly to include each authorized generic drug included in an annual report submitted to the Secretary by the sponsor of a listed drug during the preceding 3-month period. ‘‘(B) NOTIFICATION.—The Commissioner shall notify relevant Federal agencies, including the Centers for Medicare & Medicaid Services and the Federal Trade Commission, when the Commissioner first publishes the information described in subparagraph (A) that the information has been published and that the information will be updated quarterly. ‘‘(2) INCLUSION.—The Commissioner shall include in the list described in paragraph (1) each authorized generic drug included in an annual report submitted to the Secretary by the sponsor of a listed drug after January 1, 1999. ‘‘(3) AUTHORIZED GENERIC DRUG.—In this section, the term ‘authorized generic drug’ means a listed drug (as that term is used in subsection (j)) that—
VerDate Aug 31 2005
13:52 Jan 23, 2009