Drugs Frequently Potent Past Expiration
The Wall Street Journal March 29, 2000
Do drugs really stop working after the date stamped on the bottle? Fifteen years ago, the U.S. military decided to find out.
Sitting on a one billion dollar stockpile of drugs and facing the daunting process of destroying and replacing its supply every two to three years, the military began a testing program to see if it could extend the life of its inventory. The testing, conducted by the U.S. Food and Drug Administration, ultimately covered more than 100 drugs, prescription and over-the-counter.
The results, never before reported, show that about 90 percent of them were safe and effective far past their original expiration date, at least one for 15 years past it.
In light of these results, a former director of the testing program, Francis Flaherty, says he has concluded that expiration dates put on by manufacturers typically have no bearing on whether a drug is usable for longer. Mr. Flaherty notes that a drug maker is required to prove only that a drug is still good on whatever expiration date the company chooses to set.
The expiration date doesn't mean, or even suggest, that the drug will stop being effective after that, nor that it will become harmful.
"Manufacturers put expiration dates on for marketing, rather than scientific, reasons," says Mr. Flaherty, a pharmacist at the FDA until his retirement last year. "It's not profitable for them to have products on a shelf for 10 years. They want turnover."
Drug-industry officials don't dispute the results of the FDA's testing, within what is called the Shelf Life Extension Program. And they acknowledge that expiration dates have a commercial dimension.