Genentech, INIS demonstrate art of FDA response

Genentech and International Isotopes ($INIS) appear to be setting casebook examples of how to respond to the FDA over GMP concerns. Both companies filed responses to the agency within the allotted 15 working days, signaling their intention of making the requisite fixes a priority.

In Genentech's case, the Roche unit was responding to inspection observations recorded on an FDA Form 483 report following an inspection of the California plant where it makes Avastin. For International Isotopes, it's a warning letter [see related story].

"We believe that our responses are timely, thorough and complete and confirm that our operations continue to comply with cGMP standards," Genentech spokesperson Charlotte Arnold says in an emailed statement. "We are confident in the safety, sterility and purity of Avastin."

The statement continues: "We are in the process of addressing the noted observations, and have requested a meeting with FDA to discuss the responses."

The on-time response and proactive outreach to the agency are tactical actions that regulatory experts advise the recipients of FDA warning letters to take. Genentech has received no warning letter in connection with the 483 report. But the same tactics apply in 483 responses.

Not all inspection reports result in warnings; prompt, proactive, priority attention to the observations lets the FDA know that you are serious about correcting them and confident in your ability to do so.

"As noted in the Form 483, the observations do not represent a final agency determination regarding compliance," the Genentech statement says. In contrast to warning letters, which the agency considers a serious step up from 483 reports and which state violations of GMP practices, the 483 describes what inspectors saw and includes no determination of violation or compliance.

As we've reported, the name of the game is confidence when responding to the FDA regarding plant inspection findings. The manufacturer needs to exude confidence to the regulator that it's able to make the fixes and that the fixes are its priority. Genentech's meeting request to the FDA shows the company taking advantage of an opportunity to assure the regulator of its commitment. Likewise at International Isotopes. CEO Steve Laflin told us in an email that the company is "taking this opportunity to improve our manufacturing processes in complete accordance with current Good Manufacturing Practices." - George Miller (email)