Recalls expert: Keep a close eye on regulators

Drug recalls have hit a 5-quarter high, and you can expect more through end of year. So says Mike Rozembajgier, VP for recalls at Stericycle ($SRCL) ExpertRECALL, a recall service provider. Manufacturers and distributors need to keep a close eye on their regulatory agencies, as well as industry critics and consumer safety advocates, because their persistence can influence government oversight, sometimes leading to recalls.

Stericycle compiles recall lists from data issued by the FDA and the Consumer Product Safety Commission.

The FDA counted 97 pharma recalls during the second quarter of the year, involving more than 35 million units. Although the number of recalls increased, the total of items recalled was fewer than half that of the previous quarter, according to a recent ExpertRECALL study.

Following are some recall insights Rozembajgier shared with us by way of email exchanges.

What's driving the recall rise?

Rozembajgier: Regulatory agencies have been under intense scrutiny for their oversight of product safety. We expect them to keep a close eye on the companies and products they regulate. The persistence of industry critics and consumer safety advocates has often influenced government oversight.

[Ed. note: ExpertRECALL researchers look only at high-level industry data and not the nitty-gritty of individual companies. So they're unlikely to pick up on anomalies, like J&J/McNeil's truckloads of recalls, which vastly inflate the figures for that period in pharma's recall counts. The same holds true for Merck on the jobs-cut front, when its anomalous announcement of nearly 13,000 layoffs propelled pharma to the top of the Challenger, Gray & Christmas job-cuts study.]

What's the likely impact on drug recalls if Congress gets its way and drastically cuts the FDA budget?

Rozembajgier: It's hard to say.

While the implementation of new product safety initiatives by the regulator is likely to take longer with reduced budgets, the recall process remains the same. In fact, many recalls are triggered by adverse event reports by manufacturers. And manufacturers will still be required to inform the FDA about complaints, serious injuries or deaths associated with their products.

What other pharma statistics did you find?

Rozembajgier:  Recalls documented by enforcement reports increased 1% compared with the previous quarter, the largest number in the past 5 quarters. And pharma recalls increased more than 25% compared with the same quarter last year.

Of pharma's 97 recalls, 83 affected only domestic consumers. Thirteen affected consumers in both the U.S. and a territory, or the U.S. and another country. Just one recall affected only consumers outside the U.S.

In addition, four recalls involved more than a million units, compared with 15 during the first quarter.

How do you think drugmakers will react to your findings?

Rozembajgier:  Drugmakers need to be aware of what industry critics, consumer advocacy groups and product liability lawyers are doing. Manufacturers and distributors need to keep a close eye on their regulatory agencies.

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