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 [1] from The Wall Street Journal (sub. req.)
Related Articles:
Medical device makers to fund stent safety study. Report [2]
Stent study surprises. Report [3]
Decline in drug-coated stent use at cardiac centers. Report [4]
Insurers may cut stent payouts. Report [5]
Links:
[1] http://blogs.wsj.com/health/2007/08/13/congress-investigates-fda-and-jj-on-drug-coated-stents/
[2] http://www.fiercebiotech.com/story/medical-device-makers-to-fund-stent-safety-study/2006-10-25
[3] http://www.fiercehealthcare.com/story/stent-study-surprises/2005-05-04
[4] http://www.fiercehealthcare.com/story/decline-in-drug-coated-stent-use-at-top-cardiac-centers/2006-06-22
[5] http://www.fiercehealthcare.com/story/insurers-may-cut-stent-payouts/2007-04-03