Sec. 5. Public excessive drug price database
459 words·~2 min read·
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The Secretary shall establish and maintain a comprehensive, up-to-date database of brand name drugs and the excessive price determinations for such drugs under section 2. The database shall include, at a minimum, for each brand name drug, for the applicable calendar year— the name of the drug; the manufacturer; whether the drug was determined under section 2(b) to have an excessive price; the number of petitions the Secretary received under section 2(c) to make an excessive price determination for the drug, together with the information described in section 2(c)(3); the number of open, non-exclusive licenses the Secretary has granted under section 3(a)(2) for generic drug or biosimilar biological product versions of the drug; and the number of applications under subsection (b)(2) or
(j)of section 505 of the Federal Food, Drug, and Cosmetic Act or under section 351(k) of the Public Health Service Act submitted to the Secretary, pursuant to such a license granted under section 3(a)(2), and the number of such applications that have been approved. With respect to a determination made under section 2(b)(1), the Secretary shall publish on the database such determination in accordance with paragraph
(1)within 30 days of receiving domestic and international pricing information from manufacturers under section 6. Not later than 60 days after the first excessive price review under section 2 is complete, and annually thereafter, the Secretary shall submit to Congress a report describing the excessive drug price review for the preceding year. The report shall contain summary data regarding— the total number of drugs that were reviewed; the total number of drugs determined to be excessively priced under each of paragraphs
(1)and
(2)of section 2(b), and the name and manufacturer of each such drug; the total number of drugs determined to be excessively priced, listed by manufacturer; the extent to which the prices of the drugs identified under section 2 were higher than reasonable, on average; the total number of drugs for which an open-non-exclusive license has been granted under section 3(a)(2); the total number of generic drug or biosimilar biological product applications received and approved that reference a drug so licensed; the median approval time for generic drug or biosimilar biological product applications that reference a drug so licensed; the total number of petitions the Secretary received under section 2(c) to make excessive price determinations for drugs; a list of any manufacturers who failed to report information as required under section 6; and other appropriate information, as the Secretary determines or as Congress requests. The Secretary shall make the information in the database described in subsection
(a)and the report in subsection
(b)publicly available, including on the internet website of the Food and Drug Administration, in a manner that is easy to find and understand.