Will 2014 Be The Biggest Year For Drug Recalls?

New data released from the U.S. Food and Drug Administration (FDA) last month showed that 2014 could very well be the biggest year for drug recalls in the past decade.

In fact, in 2013 and thus far in 2014, there have been almost as many recalls (2061) as the previous nine years combined (2217).

Recalls can be made either by the manufacturer or the FDA and are done for a number of different reasons including packaging defects, product contamination, improper testing, or other safety issues that could compromise patient safety. However, it is up to the FDA to classify the recalls. Here is how the agency breaks them down:

• Class I recalls are when there is “reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
• Class II recalls occur when a product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
• Class III recalls would be situations “in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”

Why the recent recall surge?

The FDA’s data showed that Class I and Class III recalls have remained consistent or within the normal range.

However the interesting trend is that Class II recalls are not only becoming the norm, but they actually constitute the “overwhelming majority” of all recalls made within a given year, according to the Regulatory Affairs Professional Society (RAPS). In 2012, 2013, and 2014, Class II recalls made up 76 percent, 84 percent, and 77 percent of all recalls, respectively.

Why the rise in Class II recalls recently?  It’s tough to say for certain, however in 2012 the FDA began its crackdown on compounding pharmacies after a deadly outbreak of fungal meningitis killed more than 60 people. Analysis in Regulatory Focus found that “a sizeable number of pharmacies had products which had possible — but unconfirmed —microbial contamination.”

The publication also mentioned that other Class II recalls were due to current good manufacturing practice (cGMP) deficiencies, which can often impact dozens of products at one time.