A new study published in the Archives of Internal Medicine reveals that while drug recalls are an almost-monthly occurrence in the U.S., the system used by the Food and Drug Administration (FDA) to inform health care providers about these recalls is inadequate. In fact, the study shows that the FDA only issued official public notices for about half of even the most serious (Class I) recalls.
The study, led by Joshua Gagne of Brigham and Women's Hospital in Boston, analyzed eight years of FDA Enforcement Reports, as well as archives from the two systems the agency uses to report drug recalls—the Recall Alert System and MedWatch Safety Alert. What they found was astonishing: of 1734 drug recalls between 2004 and 2011, 91 were deemed Class I, meaning they had the greatest potential to cause serious harm or death; of those 91, the FDA only issued 55 official recall notices on the Recall Alert System. Eighteen of the remaining 36 Class I alerts were publicized on MedWatch, but the other 18 were never announced on either system.
On the other hand, the Recall Alert System was used to announce far less serious recalls, including those related to veterinary medicines. Gagne says, "It's very possible that these important recalls are being lost in the less important ones."
In response to Gagne's findings, FDA spokeswoman Sarah Clark-Lynn said, "The recall system depends on full and open disclosure by manufacturers, trust and the industry's acceptance of its responsibilities to protect the public from violative products." She also asserted that the FDA uses many different methods to communicate information about drug recalls, including social media posts, email list serves, news releases and text messages.
If the FDA has discovered that a certain drug could cause life threatening complications, not communicating this fact is unacceptable. If you or a loved one has been injured by a dangerous or recalled drug, you may be entitled to compensation. Contact a pharmaceutical attorney from Arnold & Itkin today for a free and confidential consultation.