Drug Shortages Shelf Life Extension Act

Bill: 117-s-3493
Sponsor: full_name: Sen. Cardin, Benjamin L. [D-MD]
Introduced: 2022-01-12
Policy area: Health
Subjects: Congressional oversight

Drug safety, medical device, and laboratory regulation

Government information and archives

Health technology, devices, supplies

Manufacturing
Latest action: action_date: 2022-01-12
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S191-192)

Summaries:
action_date: 2022-01-12
action_desc: Introduced in Senate
text: <p><strong>Drug Shortages Shelf Life Extension Act</strong></p> <p>This bill requires the Food and Drug Administration (FDA) to issue or revise guidance to address issues relating to extending drug expiration dates.</p> <p>Specifically, the guidance must address recommendations to drug companies relating to (1) submitting stability testing data in applications for market approval for drugs or biological products; and (2) establishing on drug labels the longest feasible expiration date supported by such data, taking into consideration how extended expiration dates may help prevent or mitigate drug shortages. </p> <p>The FDA must also periodically report to Congress certain information about requests to change the expiration date on a drug label, including the number of such requests from the FDA to the manufacturer and the rationale for each request.</p>

tv_txt: II 117th CONGRESS 2d Session S. 3493 IN THE SENATE OF THE UNITED STATES January 12 (legislative day, January 10), 2022 Mr. Cardin (for himself and Ms. Collins ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To require guidance on extending expiration dates for certain drugs, and for other purposes.

1. Short title This Act may be cited as the Drug Shortages Shelf Life Extension Act . 2. Extending expiration dates for certain drugs (a) In general Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary ) shall issue draft guidance, or revise existing guidance, to address recommendations for sponsors of applications under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) regarding— (1) the submission of stability testing data in such applications; and (2) establishing in the labeling of drugs the longest feasible expiration date supported by such data, taking into consideration how extended expiration dates may help prevent or mitigate drug shortages. (b) Report Not later than 2 years after the date of enactment of this Act, and again 2 years thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes— (1) the number of drugs for which the Secretary has requested the manufacturer make a labeling change regarding the expiration date; and (2) for each drug for which the Secretary has requested a labeling change with respect to the expiration date, information regarding the circumstances of such request, including— (A) the name and dose of such drug; (B) the rationale for the request; (C) whether the drug, at the time of the request, was listed on the drug shortage list under section 506E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356e ), or was at risk of shortage; (D) whether the request was made during a public health emergency declared under section 319 of the Public Health Service Act ( 42 U.S.C. 247d ); and (E) whether the manufacturer made the requested change by the requested date, and for instances where the manufacturer does not make the requested change, the manufacturer’s justification for not making the change, if the manufacturer agrees to provide such justification for inclusion in the report.