FDA Inadequately Informs the Public of Drug Recalls

The U.S. Food and Drug Administration (FDA) recalls a significant number drugs on a monthly basis; unfortunately, the news of these recalls is not effectively delivered to the doctors and patients. The FDA, according to a recent study, has failed to send notifications of one in five of the most serious recalls through its implemented electronic systems. This lack of communication creates detrimental effects as doctors may continue prescribe recalled medication to patients, not having received the notifications from the FDA.

The U.S. Food and Drug Administration (FDA) recalls a significant number drugs on a monthly basis; unfortunately, the news of these recalls is not effectively delivered to the doctors and patients. The FDA, according to a recent study, has failed to send notifications of one in five of the most serious recalls through its implemented electronic systems. This lack of communication creates detrimental effects as doctors may continue prescribe recalled medication to patients, not having received the notifications from the FDA.

Examples of FDA Drug Recalls

FDA has three types of recalls: Class I, Class II and Class III. Of the three, Class I recalls are issued to drugs that, according to the FDA, potentially cause "serious adverse health consequences or death." Class II recalls are labeled to drugs that may cause temporary or medically-reversible negative health effects upon consumptions or mere exposure. Lastly, Class III recalls are only made in instances where a drug is not likely to cause negative health effects, but has broken FDA regulations.

The FDA attempts to notify all three types of recalls to the public through two electronic systems: Recall Alert System and MedWatch. The Recall Alert System is the primary electronic system that is used to send recall notifications to the public, and MedWatch is used only in cases where the Recall Alert System has not sufficiently carried out the notifications. Research has shown that these systems frequently fail to effectively notify the public of the recalls that have been made. For example, a study showed that over 1,700 drug recalls were listed in the FDA's enforcement reports from 2004 to 2011. Of these recalls, 91 were serious Class I recalls, but notifications on only 55 of them were delivered through the Recall Alert System. MedWatch only sent out 18 out of the remaining 36 recalls-the rest were never informed to the public. An FDA representative reported to Reuters Health that she was not able to state why the remaining 18 Class I recall notifications were not publicized effectively.

Growing Need For Efficient, Active Tracking

There's no way to "know if the lack of notification were linked to any patient harm," says Joshua Gagne from Brigham and Women's Hospital in Boston. However, it is clear that the lack of notifications hinder the communication between the FDA and the public sphere of doctors and patients, which could consequently put patients in medical risk. Gagne added that the FDA has this issue "on their radar" and are "starting initiatives to address it."

One solution is to use both of the electronic systems to ensure that "everyone [knows] about Class I drug recalls," says Dr. Lisa Schwartz, co-director of the Center of Medicine & Media at the Dartmouth Institute. Another way, according to Gagne, is to require drug companies to send letters to doctors directly, informing them of the recall.

Regardless of the method, the FDA does indeed need to implement a specific system that sufficiently delivers the news of Class I recalls, if not those of all classes.

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