Should Drugs Be Used After Expiration Dates to Manage Cost of Healthcare?
[Posted on: Thursday, July 20, 2017] Using a drug beyond its expiry date is a scary thought. Each year prescription and OTC drugs worth hundreds of millions of dollars are trashed once they reach their published expiration dates. A given drug, when properly stored, may not lose much potency and be still safe and effective beyond its stated expiration date but most consumers do not know that. And it is not true for all drugs. About one-third of drugs tested beyond their expiration dates were found to have significantly lost their stated potency and likely contained harmful degradation products. But the rest two-thirds of the products were fine much after their expiry dates. By safely using drugs beyond their expiration dates, the consumers could save hundreds of millions of dollars each year based on research by a few non-profit public interest groups. For more than 30 years, federal agencies that stockpile drugs — including the military, the CDC and the Department of Veterans Affairs — have used technically expired drugs under the Shelf-Life Extension Program (SLEP) in collaboration with FDA. The SLEP program applies to drugs, not biologics, which forms the Strategic National Stockpile (SNS). Just the Department of Defense saves about $3.1 billion per year using SLEP by not having to replace expired drugs in its stockpile. So, in principle consumers can similarly use expired drugs and save money. The expiration date for a given drug is based on the stability program conducted by the manufacturer which typically runs for about 2-4 years. FDA does not require more than 3 years of stability data for most drugs for market approval. Longer stability programs are hence rarely conducted. There is little incentive for the manufacturers to increase the shelf life of their products except in events of drug shortage or health emergencies. And there is potentially huge liability if someone gets hurt by consuming an expired drug. However, in principle, FDA could leverage its experience from SLEP to expand the list of drugs that can be used beyond their expiration dates. It boils down to the regulatory processes and the parties with the most at stake. The consumer and healthcare providers are probably the biggest beneficiaries of extended shelf-life of medical products. From the regulatory point of view, the data needed to support expiration date extension could come from testing by national labs or independent research. May be this is good use of the Real World Evidence provisions of the 21st Century Cures Act, where evidence from diverse sources can be used to support new uses of previously approved drugs. Information regarding the extended shelf-life of a drug could be technically considered to support label revisions. There exist precedence for FDA and the affected party extending the shelf-life of a drug without involvement of the manufacturers, such as that used by federal agencies. The affected parties in this case could be the FDA along with public interest groups, consumer protection groups, healthcare providers such as hospital and pharmacy groups, who can use independent testing data to support extending the expiration date of stored drugs. The measure can be implemented quickly for drugs for which information is already available and extended to additional products as more independent research data becomes available. These are times when drug price control is at the forefront of all discussions healthcare and FDA has taken an active role in support; measures that could lead to significant cost reduction deserve to be discussed.
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