A $1.8 billion market for metal tubes used to clear blocked arteries outside the heart may be upended by a U.S. probe into marketing practices by Johnson & Johnson, Boston Scientific Corp. and Abbott Laboratories.
The Food and Drug Administration says the device makers have already curtailed what the government views as improper sales practices since the Justice Department notified them of the inquiry earlier this summer. The companies are seeking new studies to justify implanting similar stents in veins and arteries, and face a slowdown in sales that have reached $900 million with the unauthorized uses.
While the FDA approved the stents only for clearing bile ducts in liver cancer patients, unsanctioned uses for keeping veins and arteries unclogged increased revenues tenfold, according to research published in the American Journal of Therapeutics. At that rate, J&J in June estimated a $1.8 billion market for the stents by 2012, which now seems unlikely, said Frost & Sullivan Inc. analyst Venkat Rajan.
"If they want to expand this market beyond what it has been, then it's now going to involve new trials," Rajan, based in San Antonio, said in an Aug. 21 telephone interview.
The FDA warned device makers about promoting biliary stents for uses other than treating cancer during a March 2007 meeting, said Ann Simoneau, an FDA attorney.
The FDA has identified safety risks with unapproved use of biliary stents, agency spokeswoman Karen Riley said Thursday.
More than 90 percent of biliary stent injuries or malfunctions reported to the FDA from 2001 to 2006 involved off-label use, according to an agency study in the July issue of the Journal of Vascular and Interventional Radiology. The number of annual injuries or malfunctions more than tripled during this time frame, to 339 in 2006. Fourteen deaths from off-label use were reported to the FDA in the six-year period.
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