Sec. 404. Increasing generic drug competition
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Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.) is amended by inserting after section 506E the following: The Commissioner shall— not later than 9 months after the date of enactment of the Improving Access To Affordable Prescription Drugs Act , publish a complete, up-to-date list on the Internet website of the Food and Drug Administration of all generic drugs (including drug trade name, active pharmaceutical ingredient manufacturer, active finished dosage form manufacturer, any contract manufacturing organization, the date the authorized generic drug entered the market, and marketing status); designate each drug on the list that is a sole-source drug; and maintain a confidential list of the identity and address of each manufacturer and labeler associated with a drug reported under this section, and publicly report on the website only the city and State or country of each such manufacturer and labeler.
The Commissioner may choose not to make information collected under subsection
(a)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 subsection
(a)that the information has been published and will be updated regularly. In this section: The term manufacturer means a person engaged in the manufacture of an active pharmaceutical ingredient or finished dosage form, as defined in section 744A. The term sole-source means— A drug for which there is only one approved manufacturer listed in the active section of the Approved Drug Products With Therapeutic Equivalence Evaluations (commonly known as the FDA Orange Book ); and for which there are no blocking patents or exclusivities that may receive expedited review, except where the drug was approved pursuant to a suitability petition under section 505(j)(2)(C). . Section 510(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(j) ) is amended by adding at the end the following: Each person who registers with the Secretary under this section shall report to the Secretary any contract with a contract manufacturing organization with respect to any drug such person manufacturers, distributes, or compounds, including the start date and end date of such contract. . Section 506C(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c(a) ) is amended by striking of a drug— and all that follows through the end of paragraph
(2)and inserting of a drug . Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.) is amended by inserting after section 506C–1 the following: If the Secretary determines that the number of manufacturers of a drug approved under section 505 or a biological product licensed under section 351 is less than 2, the Secretary may— with respect to a manufacturer with fewer than 500 employees, including employees of affiliates of the manufacturer, waive the prescription drug application fees under sections 736(a), 744B(a), or 744H(a); expedite the review of applications for the drug under section 505(j) or section 351(k) of the Public Health Service Act until the number of manufacturers of the drug is at least 4; and after consultation with the Federal Trade Commission to ensure that the manufacturer has not engaged in anticompetitive tactics to remove other manufacturers from the market in order to incentivize such a contract, establish and prioritize purchase contracts with manufacturers who are holders of applications approved under section 505(j) or section 351(k) of the Public Health Service Act for the drug but who are not currently manufacturing such drug. The Secretary shall promulgate regulations to establish guidelines for the drugs with respect to which the Secretary may establish purchase contracts in accordance with subsection (a)(3). Such guidelines shall provide that any such purchase contract may be only with respect to a drug that is listed as an essential medicine by the World Health Organization, or another external entity, as the Secretary may specify, that meets evidence-based standards as the Secretary may require. If a manufacturer enters into purchase contract in accordance with subsection (a)(3), the Secretary, in cooperation with the Office of the Inspector General, shall establish a limit on the retail price at which the drug may be made available to consumers in the United States. .
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