Who's the drug watchdog's watchdog? Congress, of course--and it's barking at the FDA and Johnson & Johnson. Late yesterday, the House Committee on Energy and Commerce asked for more information about contamination problems the drug agency found in 2004 at J&J's Cordis unit, which makes a drug-coated stent called Cypher. The FDA sent a letter to Cordis at the time, notifying the company of "systemic violations" that caused the stents to be adulterated during the manufacturing process.
Now, the committee wants to know why J&J was allowed to continue selling the Cypher stents--and it plans to dig through emails, notes, reports, and the like, plus interview people at the FDA and J&J.
- read the report from The Wall Street Journal (sub. req.)
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