FDA officials are not consultants to OEMs. Which is not to say that FDA doesn't want to help, Barbara Cassens, director of the agency's San Francisco District Office, told those at the RAPS Horizons conference in late March. But its job is enforcement, and there simply isn't enough time to spend more than an hour with companies that are seeking resolution on FDA-483 observations or warning letters.
Cassens and Ron Johnson, an FDA consultant, presented a demonstration highlighting common mistakes OEMs can make when at FDA meetings. These include not being prepared, not asking FDA who will be attending the meeting, making poor use of time, making rash committments, and leaving the table without a clear plan of action.
The speakers also discussed how difficult it can be to understand FDA's position in the process, because as stated above, the agency is an enforcer, not a consultant. "You have to respect FDA's role," Cassens said, "but also realize that we are people too."