FDA Enforcement Heating Up

Law360, New York (November 20, 2009, 12:48 PM EST) -- Recent statements by U.S. Food and Drug Administration and Department of Justice officials, including FDA Commissioner Margaret Hamburg, promised an increase in enforcement. Recent events on several fronts demonstrate that this is no idle threat.

On Oct. 28, 2009, the government announced a criminal indictment against Stryker Biotech and four current or past executives.

The indictment, filed in federal court in Massachusetts, alleges that the company and the named executives promoted an unapproved combination of two orthopedic products used as bone fillers.

Each product had been...
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