Lawmakers Ask How J&J’s Heart Stent Was Handled by FDA

A U.S. House committee is investigating whether the Food and Drug Administration took proper action after finding that Johnson & Johnson’s Cordis unit violated laws in manufacturing its drug-coated heart stent. FDA inspectors found “numerous systemic violations” in certain practices involving the Cypher stent, according to statements today by Michigan Democrats John Dingell, chairman of the House Energy and Commerce Committee, and Bart Stupak, chairman of the Oversight and Investigations Subcommittee. The lawmakers said Cordis, based in Miami Lakes, Florida, was allowed to continue marketing the device, a wire-mesh tube coated with drugs to prop open diseased arteries, after the FDA found manufacturing errors during inspections in September, October and December 2003. “Despite these numerous violations, however, Cordis was allowed to continue marketing Cypher stents,” Dingell and Stupak wrote. They said the agency didn’t issue a warning letter until April 2004. Demand for the stents coated with medicine, used to prevent scar tissue from forming around the device, has shrunk in the past year after studies linked them to a higher rate of blood clots compared with older, bare-metal models. Research also showed that the devices weren’t better than drugs in treating heart disease. J&J, based in New Brunswick, New Jersey, and Boston Scientific Corp., dominate the $5.4 billion-a-year global market for stents coated with drugs, and they produce the only models sold in the U.S. FDA Correspondence Lawmakers are requesting that the FDA and J&J submit any correspondence they had from September 2003 to June 2007 that involved Cypher, according to the statement. They also asked for internal communications at J&J during the same period. J&J continued to sell Cypher in 2004 after the FDA cited manufacturing problems. The agency lifted its warning in June 2007 after J&J resolved issues, according to Christopher Allman, a Cordis spokesman, in an e-mailed statement. “Cordis will cooperate with the Committee in regard to its requests for information,” he said. Karen Riley, an FDA spokeswoman, didn’t immediately return a phone call seeking comment. SOURCE: Bloomberg