According to the FDA, amending the expiration date of some prescription drugs may alleviate the shortages the United States is currently is facing.
Last week, US 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 US Food and Drug Administration (FDA) to extend the shelf life of prescription drugs in scarce supply.
Said Senator Collins:
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. 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.
Said Senator Cardin:
The US is the wealthiest nation in the world; no one in this country should fall victim to prescription drug shortages. 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 legislation 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 Committee and House Energy and Commerce Committee including information on labeling changes regarding product expiration dates that the Secretary requests of manufacturers.
Allergic individuals who must carry epinephrine auto-injectors often complain about the expense of having to replace them every year, this despite research published in a study from The Journal of Allergy and Clinical Immunology: In Practice that shows the majority of epinephrine auto-injectors retained over 90% concentration of epinephrine years after expiration dates, regardless of the manufacturer.
If enacted, this legislation could well safely extend the official expiration dates of epinephrine auto-injectors by months or even years.