Two House committees announced they are investigating the regulatory and enforcement
decisions made by the Food and Drug Administration concerning a series of post-approval
inspections in late 2003 of Cordis Corp.s popular CYPHER drug-eluting stents.
The investigations by the Energy and Commerce Committee and its Oversight and
Investigations subcommittee are part of a broader look into the FDAs ability to protect
consumers from excessive risks associated with the medical products that it regulates,
according to federal lawmakers.
The committees said they want to know why Cordis, a Johnson & Johnson subsidiary,
continued to develop its coronary stent after the FDA in 2004 sent a warning letter that
laid out numerous systemic violations found in the manufacturing process.
In letters sent to FDA Commissioner Andrew von Eschenbach and J&J chief executive William
Weldon, committee leaders requested all communications sent both in-house and externally
between the two.
Cordis received FDA approval to market the CYPHER brand in 2003, according to a fact sheet
on the companys Web site, and three years later more than 1.5 million patients were
treated with it worldwide. -- by Matthew
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