Just as it had suspected, Gilead Sciences got a warning letter from the FDA for manufacturing problems at its San Dimas, California, site. Gilead had given investors a heads-up about the potential warning after FDA inspectors didn't like what they saw during a plant visit.
Indeed, FDA isn't just worried about the individual infractions inspectors turned up, Gilead states in a regulatory filing. In its letter, the agency "expresses a generalized concern over the effectiveness of the San Dimas quality unit in carrying out its responsibilities," the company says.
The FDA particularly cited shortfalls in manufacturing procedures for AmBisome, a treatment for fungal infections; unless and until the problems are resolved, Gilead may not be allowed to export AmBisome to certain countries. Supplies of other aseptically packaged products made at San Dimas--Cayston for cystic fibrosis and eye drug Macugen--could be disrupted as well. But, as Pharmalot reports, analysts aren't too fussed about the problems, saying that they appear "manageable."
Gilead says it's already addressed some of the FDA's concerns and it's dealing with the rest now. "We are working diligently to resolve any outstanding FDA concerns listed in the warning letter," Nathan Kaiser, a Gilead spokesman, tells Bloomberg.
It's not much consolation for Gilead--or for industry watchers in general--but the drugmaker is in good company. The FDA has been turning up manufacturing infractions at drug plant after drug plant, including the much publicized problems at Genzyme and Johnson & Johnson's McNeil Consumer Healthcare unit. What's going on? Well, in an interview with InPharm, an FDA official says it's not that companies are more lax these days. It's that FDA is more on the ball.