When it comes to making a manufacturing comeback from the GMP violations cited in an FDA warning letter, the name of the game is confidence. The FDA needs to be made confident that the manufacturer understands both the operations issues that need to be addressed and the importance of those issues. The manufacturer needs to exude confidence to the regulator concerning its ability to make the fixes and to make them its priority.
If the violations have resulted in a plant shutdown or consent decree, the confidence factor rises in importance. In such cases, like Genzyme's, executive presence is required. Not because of any regulatory requirement, but because that's what it takes to give the FDA confidence that the manufacturer will follow through.
"In almost all cases, the most senior executive needs to get in front of the FDA," says Jim Prutow, a partner in PRTM's healthcare practice, in an interview with FiercePharmaManufacturing. "Even just at the warning letter stage, most companies would want to get senior executives to FDA to meet and to ensure understanding, showing a commitment to provide the necessary resources. That's how to get through the process as expeditiously as possible."
PRTM is a consultancy that works with top 20 pharma companies, including those finding themselves with FDA-related issues. Prutow, an expert on quality and regulatory matters, has hands-on experience working with clients to address FDA warning letters. He says that manufacturers in violation of GMPs need to be proactive in communicating. "You don't want the FDA guessing about what you're doing or how serious you are."
Even more so with Congress, in unfortunate cases like J&J's where the violation impact is so great that legislators take the ball from the FDA. CEO Bill Weldon, sending a substitute in response to his first invitation to speak with the House Committee on Oversight and Government Reform, has missed a chance at confidence-building. He's lucky to have been extended a second invitation, a second chance to build confidence in his ability and sincerity to get McNeil and Tylenol back on track. It's now a more difficult task given the missed opportunity and the Committee's perception that the company has been uncooperative.
No matter how bad the problems, how poor the reasons, it's time for J&J to step up. Company financials notwithstanding, and in spite of whatever PR capacity the company has to weather this storm among consumers and shareholders, extended plant closure, consent decree, fines, inventory seizure and even executive prosecution are all on the FDA discretionary table. - George Miller