Hospitals and pharmacies are required to toss expired drugs, no matter how expensive or vital. The idea that drugs expire on specified dates goes back at least a half-century, when the FDA began requiring manufacturers to add this information to the label. Meanwhile the FDA has long known that many remain safe and potent for years longer.
Federal and state laws prohibit pharmacists from dispensing expired drugs and The Joint Commission, which accredits thousands of health care organizations, requires facilities to remove expired medication from their supply. Outdated drugs are shunted to shelves in the back of the pharmacy and marked with a sign that says: “Do Not Dispense.” The piles grow for weeks until they are hauled away by a third-party company that has them destroyed. And then the bins fill again.
Though the government requires pharmacies to throw away expired drugs, it doesn’t always follow these instructions itself. Instead, for more than 30 years, it has pulled some medicines and tested their quality. The story on ProPublica claims that the federal government has stockpiled massive stashes of medication for decades, antidotes and vaccines in secure locations throughout the country. The drugs are worth tens of billions of dollars and would provide a first line of defense in case of a large-scale emergency.
The federal agencies that stockpile drugs – including the military, the Centers for Disease Control and Prevention and the Department of Veterans Affairs – have long realized the savings in revisiting expiration dates.
In 1986, the Air Force, hoping to save on replacement costs, asked the FDA if certain drugs’ expiration dates could be extended. In response, the FDA and Defense Department created the Shelf Life Extension Program. The program authorizes governmental stockpiling and use of expired drugs.
FDA’s Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. The FDA Center for Drug Evaluation and Research (CDER) Division of Product Quality Research analyzes the data and makes decisions regarding shelf life extensions.
Each year, drugs from the stockpiles are selected based on their value and pending expiration and analyzed in batches to determine whether their end dates could be safely extended. For several decades, the program has found that the actual shelf life of many drugs is well beyond the original expiration dates.
A 2006 study of 122 drugs tested by the program showed that two-thirds of the expired medications were stable every time a lot was tested. Each of them had their expiration dates extended, on average, by more than four years, according to research published in the Journal of Pharmaceutical Sciences.
The billion dollar question asks why it is this research has not extended to the private sector? Pharmacists and researchers say there is no economic “win” for drug companies to investigate further. They ring up more sales when medications are tossed as “expired” by hospitals, retail pharmacies and consumers despite retaining their safety and effectiveness.
Some medical providers have pushed for a changed approach to drug expiration dates – with no success. In 2000, the American Medical Association, foretelling the current prescription drug crisis, adopted a resolution urging action. The shelf life of many drugs, it wrote, seems to be “considerably longer” than their expiration dates, leading to “unnecessary waste, higher pharmaceutical costs, and possibly reduced access to necessary drugs for some patients.”
No one remembers the details of the AMA resolution – just that the effort fell flat. “Nothing happened, but we tried,” says rheumatologist Roy Altman, now 80, who helped write the AMA report. Experts estimate such squandering eats up about $765 billion a year – as much as a quarter of all the country’s health care spending.