Collins, Cardin Introduce Bill to Address Prescription Drug Shortages

Legislation would direct FDA to lengthen expiration dates, where safely possible, to help mitigate drug shortages

Washington, D.C.- U.S. Senators Susan Collins (R-ME) and Ben Cardin (D-MD) introduced the Drug Shortages Shelf Life Extension Act, a bipartisan bill that would direct the U.S. Food and Drug Administration (FDA) to 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.

"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."

"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."

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 labeling changes regarding product expiration dates that the Secretary requests of manufacturers

The bill text can be read here.

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Senator Collins has been a longstanding champion of strengthening our nation's medical supply chain. In 2020, Components of the Mitigating Emergency Drug Shortages (MEDS) Act, legislation Senator Collins co-authored, was signed into law. The law expedites the review of drug marketing applications and inspections in the event of a shortage as well as increases manufacturing reporting requirements.

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