Stryker Biotech Indicted Over OP-1 Marketing
BY LAUREN UZDIENSKI, OCTOBER 28, 2009
Stryker Biotech is facing a federal indictment after a long investigation into its sales of OP-1 (BMP-7), which was approved by the FDA under an HDE. An HDE stipulates that a device will be used in less than 4,000 patients annually, and an FDA panel found OP-1 not approvable for larger populations back in April.
OP-1 is indicated for revision posterolateral lumbar spine fusion and for the treatment of long bone nonunion fractures, but the U.S. government alleges that the company encouraged off-label use of the device. Specific charges include wire fraud, conspiracy, misbranding and making false statements to the FDA. The named defendants are Stryker Biotech LLC, a former president of Stryker Biotech and three sales managers, all of whom face up to 20 years in prison and fines of $250,000 per count. Two other former sales managers pleaded guilty to charges associated with OP-1 misbranding earlier this year.
In response to the charges, Stryker said they were "disappointed" by the U.S. attorney's actions, noting that conviction could be costly for the company and limit the Biotech division's ability to participate in federal and state health care programs (like Medicare). Beyond that, the company said they would have no further comment.
