Sec. 404. Increasing drug competition and preventing drug shortages
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Section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(7) ) is amended by adding at the end the following: The Commissioner shall— not later than 9 months after the date of enactment of the Affordable Medications Act , publish a complete, up-to-date list on the internet website of the Food and Drug Administration of all drugs, including authorized generics, together with, with respect to the drug, as applicable— the drug trade name; the established name; each active pharmaceutical ingredient facility (as defined in section 744B(a)(4)(a)(ii)); each generic drug facility; each contract manufacturing organization facility (as defined in section 744A(5)); the date any authorized generic drug entered the market; the marketing status; and any other information the Secretary may require to mitigate or prevent drug shortages; designate each drug on the list that is a sole-source generic drug; designate each drug on the list that is an essential medicine, as identified by the World Health Organization, or another entity designated by the Secretary that meets evidence-based standards as required by the Secretary; and maintain a confidential list of the identity and address of each facility described in subclause (I), and publicly report on the website only the city and State or country of each such facility.
The Commissioner may choose not to make information collected under clause
(i)publicly available if the Secretary determines that disclosure of such information would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of drug products to patients). 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 under clause
(i)that the information has been published and will be updated regularly. In this subparagraph, the term sole-source means, with respect to a drug, there is not more than one approved drug on the list of drugs under subparagraph (A), not including drugs on the discontinued section of such list. .
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Sec. 404
Increasing drug competition and preventing drug shortages
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