Ed Silverman - The Number Of Drug Recalls Is Rising How Fast?

http://www.pharmalot.com/2011/11/the-number-of-drug-recalls-is-rising-how-fast/

By Ed Silverman // November 8th, 2011

During the third quarter of this year, the number of pharmaceutical recalls jumped to 150, compared with about 90 recalls during each of the first two quarters of 2011, according to FDA Enforcement Reports. Moreover, the recent tally dwarfs the roughly 65 recalls that were made during the last quarter of 2010 and nearly doubled the 80 recalls that were notched during the 2010 third quarter.

The simple reason for this spike is more aggressive activity by the FDA, according to Mike Rozembajgier of Stericycle, a medical waste management that examined the agency reports. “As the FDA increases its scrutiny of pharmaceutical and medical device supply chains, we can expect to see more recalls that affect consumers worldwide,” he tells us.

Indeed, the FDA has tried to get tough on safety and supply issues thanks, in part, to the twin shocks of the Vioxx recall in 2004 and the heparin scandal four years ago. The agency has been under pressure from Congress to tighten its oversight of the supply chain, in particular (see this). He notes the FDA is working on a deal with generic drugmakers that would require foreign manufacturing plants to be inspected at the same frequency as domestic plants.

For those wondering which type of drug was affected most by recalls in the recently ended third quarter, more than 60 percent were Class II drugs, and 30 percent were Class III. Less than 7 percent of the recalls were Class I drugs. [UPDATE: For those wondering, the firm relied on FDA definitions: a Class I recall involves a reasonable probability the product will cause serious adverse health consequences or death. Class II recall is a product that could cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. And Class III recall as a situation in which a drug product is not likely to cause adverse health consequences.]

Interestingly, the data showed that recalls in the third quarter of this year affected nearly 30 million units, down from about 35 million units in the second quarter and 87 million in the first quarter. Similarly, there were 180 million units affected by recalls in the fourth quarter of 2010 and more than 230 million units in the third quarter of 2010.