Looking for hard evidence that the FDA is tightening approval standards? Here it is. The agency today proposed tougher clinical trial guidelines for drug-coated stents. Rather than letting new versions of the artery-decloggers onto the market after nine months of study, the new rules would require data collected two years after the procedure. Then, after the stent is approved, companies would continue monitoring the product for complications, preferably for five years.
The new guidelines closely follow standards the agency used to assess new stents from Medtronic and Abbott Laboratories. The more stringent analysis of those products came after studies raised concerns about blood clotting in the stents long after they were implanted. For about a year, warring research muddied the safety waters around coated stents, but consensus has settled around a "perhaps" for clots years after the procedure and a "probably not" for increased deaths or blood clots overall. The FDA's new rules seek to minimize the "years later" risk, and according to analysts, aren't a big surprise. They "conform to the way the industry has already been thinking about product design," one told the Wall Street Journal. We'll see how the companies themselves respond.
- see the WSJ story
- check out the article in the Chicago Tribune