Bristol-Myers Squibb officials promise that they're scrambling to fix "significant" problems at a Puerto Rico plant. During yesterday's earnings call, CEO Lamberto Andreotti discussed an FDA warning letter about the factory, saying he's well aware that the agency may not approve new drugs slated to be made there.
That would be Belatacept, an experimental transplant drug. As a BMS spokeswoman told the Associated Press, the biologic drug is made in Syracuse, New York, but packaged at the Manati plant. Other drugs made there include the antipsychotic drug Abilify and anti-inflammatory treatment Orencia, both injectables, and the Coumadin anti-clotting remedy.
According to the FDA letter, inspections in March of this year found "significant violations" of good manufacturing practice, including problems that the agency had tagged before. That's why the agency put BMS on notice about blocking new approvals there. The company now hopes to have the plant reinspected by year's end, aiming for approval of Belatacept during the second quarter of 2011.