Additional safety studies of medical devices like stents may help patients and consumer confidence, but such reviews could level a financial hit to makers of those products, such as North Chicago-based Abbott Laboratories.
The stepped-up scrutiny comes as the U.S. Food and Drug Administration has been under pressure from Congress and consumer groups over its perceived lax oversight of devices and drugs.
The drug industry has been shaken by some high-profile cases involving safety. The painkiller Vioxx, for example, was withdrawn in September 2004 after a study linked the drug to increased risk of heart attacks. In the last two years studies have linked drug-coated stents, tiny scaffoldlike metal devices used to keep arteries open, to potentially dangerous blood clots and have hurt their sales.
In May the FDA announced its “Sentinel Initiative,” which provides a national electronic monitoring system for medical product safety, allowing the agency to “query multiple existing data sources, such as electronic health record systems and medical claims databases, for information about medical products,” agency officials said at the time.
Stentmakers Abbott, Johnson & Johnson, Boston Scientific Corp. and others recently have launched products in the U.S. or have them in the pipeline. These firms could be particularly “vulnerable” considering the scrutiny of drug-coated stents and especially if the new monitoring uncovers a problem, Moody’s Investors Service said.
“The increased scrutiny could lead to greater volatility in sales and profitability for some medical device companies down the road,” Moody’s vice president and senior credit officer Diana Lee said in a report this month.
Abbott said Wednesday that second-quarter earnings exclusive of special items surged a stronger-than-expected 21.6 percent, thanks largely to a jump in prescription drug sales. Revenue climbed 14.8 percent, to $7.31 billion from last year’s $6.37 billion.
Abbott expects its vascular business to be a stronger contributor in the third quarter because of the U.S. launch of its next-generation drug-coated stent called Xience.
Many of the makers of drug-coated stents are now or will begin conducting “postmarket” studies of stents. The FDA is encouraging more studies of medical products after the products have reached the market. In the past, companies’ attentions were largely focused on studies to win U.S. approval just to get the product on the market.
Abbott last week said it started its postapproval study, with six hospital centers already recruiting and enrolling patients just one week after the FDA’s approval of Xience. Abbott, which would not disclose costs of the study, said its postmarket review will eventually study 5,000 patients for five years.
“Because device manufacturers must bear the expense of postmarket studies, we believe that these companies will need to focus on making [research and development] dollars go further,” Lee of Moody’s said.
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Hear Bruce Japsen on WGN-AM 720 Mondays at 12:49 p.m. and 11:15 p.m. and Sundays at 7:35 a.m.
bjapsen@tribune.com
