Rx DRUGS: Is Expiration Date for Marketing or Safety?

      Some prescription drugs may be safe and effective long after their expiration date, the Wall Street Journal reports. In 1985, faced with having to destroy and replace a $1 billion stockpile of drugs, the U.S. military "began a testing program to see if it could extend the life of its inventory." The FDA studied more than 100 drugs, finding that 90% were safe and effective after their original expiration date, and at least one was safe for 15 years after its expiration. Since the Shelf Life Extension Program started, the FDA has endorsed Bayer's Cipro, the tranquilizer Thorazine, Valium, Tagamet, Dilantin and antibiotics tetracycline and penicillin for expiration extensions. In the first year of the program, the Air Force paid the FDA $78,000 for testing and saved 59 times that sum because it did not need to replace drugs.

For Marketing Purposes?
      Francis Flaherty, a former director of the testing program, said that "expiration dates put on by manufacturers typically have no bearing on whether a drug is usable for longer," adding that manufacturers put expiration dates on for marketing purposes. The FDA only requires drug makers to prove that a drug is still good on the expiration date the company chooses. Although the FDA cautions that there is not enough evidence from the testing program to conclude that most drugs are potent beyond the expiration date, Joel Davis, former FDA expiration compliance chief, said that except for nitroglycerin, insulin and some liquid antibiotics, most drugs in consumers' medicine cabinets "are probably as durable as those the agency has tested for the military." He added, "In all likelihood, you can take a product you have at home and keep it for many years, especially if it's in the refrigerator."

A Matter of Public Safety
      While the drug industry does not dispute the FDA's findings, it notes that public safety, not marketing tactics, play a key role in setting expiration dates. If older drugs are discarded within a couple of years, drug officials maintain that new, more beneficial drugs can be brought on the market more easily. Also, label redesigns are more effective if consumers don't have earlier versions that could lead to confusion. Drug company officials argue that "any liability or safety risk is diminished by limiting the period during which a consumer might misuse or improperly store a drug." Frank Holcombe, associate director of the FDA's office of generic drugs, said that drug makers could extend expirations, but doing so they "would have to keep doing stability studies and keep more in storage than [they] would like" (Cohen, 3/28).