• 08
  • June
    2012

If you were taking a prescription drug that had been recalled, wouldn't you want to know about it right away? Most people would assume the Food and Drug Administration always alerts the public about recalls of dangerous and defective drugs, but this is not necessarily true.

In fact, the FDA sometimes fails to notify doctors and patients about Class I recalls, which is the classification for drugs that have the greatest likelihood of causing serious injury or death.

This startling lapse in communication is explored in recent study published in the Archives of Internal Medicine. The results suggest that the system for managing prescription drug recalls in the U.S. is piecemeal at best, and American patients could be in serious danger until or unless improvements are made.

The study's researchers examined data on drug recalls issued between 2004 and 2011. Of the thousands of drugs recalled over that 8-year period, 91 were labeled as Class I recalls.

The FDA has two systems for reporting recalls: the MedWatch Safety Alert and the Recall Alert System. Yet even with two systems, 18 of these 91 recalls were never communicated publicly.

Critics of the FDA's reporting systems point out that the Recall Alert System also broadcasts notices which are less urgent, like recalls of veterinary drugs. Therefore, one of the study's authors notes, "It's very possible that these important recalls are being lost in the less important ones."

Another major problem, according to researchers, is that the FDA cannot legally force companies to issue recalls. Therefore, even if the FDA's recall reporting was drastically improved, it may not be enough to alert consumers about every dangerous or defective drug on the market.

The systemic flaws revealed in this report cannot be fixed solely by the FDA or major drug companies. Rather, it will likely take the combined efforts of legislators, drug manufacturers, the FDA and consumer-safety advocates to bring about widespread and effective changes.

Source: ABC News, "U.S. Has Drug Recall Problem, Study Says," Carrie Gann, June 4, 2012