Court slams FDA decision on Ivax patent

Medical Marketing and Media, Jan 2002 by Dickinson, James G

WASHINGTON INSIDER

FDA lawyers were left reeling after the U.S. Court of Appeals for the District of Columbia ruled on November 6 that the agency's Office of Generic Drugs (OGD) erred when it approved a Baker Norton Pharmaceuticals' (an Ivax Corp. subsidiary) application 14 months earlier for a generic copy of Bristol-Myers Squibb's Taxol (paclitaxel).

While the court said it did not know what recourse is left for the FDA in taking steps to affect the marketing of generic versions of Taxol now on the market, one senior FDA official stated that, hypothetically, it could seek a withdrawal of all generic paclitaxel products. The appeals court, ruling in American Bioscience vs. Thompson, particularly took issue with, and harshly criticized, OGD Director Gary Buehler's rationale for approving Baker Norton's application.