January 12, 2022

Cardin, Collins Lead Bill to Address Prescription Drug Shortages

Senators call on FDA to lengthen expiration dates, where possible, to help mitigate drug shortages

WASHINGTON U.S. Senators Ben Cardin (D-Md.) and Susan Collins (R-Maine) today introduced the bipartisan Drug Shortages Shelf Life Extension Act, which would have the U.S. Food and Drug Administration (FDA) extend the shelf life of prescription drugs in scarce supply. According to the FDA, amending the expiration date of some prescription drugs may alleviate the shortages that the United States currently is facing.

“The U.S. is the wealthiest nation in the world; no one in this country should fall victim to prescription drug shortages,” said Senator Cardin. “The federal government must work to ensure that patients who rely on life-sustaining medications for the treatment of infections, cancer, autoimmune conditions, and for basic medical procedure necessities, like saline or epinephrine, will always have an adequate supply of the prescription drugs they need. No one should have to go without essential prescriptions drugs when usable supplies are available despite the date stamped on their box or bottle.”

“At a time when our health care system is overburdened by the COVID-19 pandemic, the last thing doctors, nurses, and patients should have to worry about is whether there will be an adequate supply of the medications they need,” said Senator Collins. “To help ensure all patients have access to lifesaving medications, our bipartisan legislation would update FDA guidance in order to safely extend the shelf life of essential drugs.”

As FDA noted in their 2019 Drug Shortages Task Force Report, shortages of essential drugs may be, “… exacerbated if drugs must be discarded because they exceed a labeled shelf-life based on unnecessarily short expiration dates.” The regulations that govern prescription drug shelf life testing have not been amended since 1981. Therefore, in order to ensure the accuracy of shelf life data, it is imperative that regulations governing shelf life stability testing are up-to-date.

The Drug Shortages Shelf Life Extension Act would:

  • Update FDA guidance regarding stability testing tied to shelf life expiration dates.
  • Require the FDA to submit a report to the U.S. Committee on Health, Education, Labor and Pensions (HELP) Committee and House Energy and Commerce Committee including information on requests from the Secretary for manufacturers to make labeling changes regarding the expiration dates.

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