Consent decrees in the drug industry require that a third party be appointed to participate, oversee and review changes made to bring the facility back into GMP compliance. Genzyme has already hired Quantic Group for the Allston Landing overhaul, and the consultancy is now "integrated with every step of the process," Ron Branning, senior VP for global product quality, said during an investor call.
Quantic has 30 experts situated at Allston Landing and other Genzyme sites. Branning noted the FDA has looked favorably in the past on Quantic as a third-party overseer in consent decree actions, and he hopes the regulator may be so inclined in this case.
Branning maintains that Genzyme is "on track" with facility and process improvements that address the noncompliance matters observed by FDA inspectors in a recent visit. Most are related to fill/finish operations.
Pamela Williamson, senior VP and head of regulatory affairs and corporate quality compliance, echoed the on-track assessment. She revealed that the FDA acknowledged in a recent meeting that Genzyme has "met all of its commitments regarding Form 483 resolutions," which to date is about half of those cited. "We have solicited and sought FDA's advice on what we could do. There is nothing they have suggested that we should do differently to raise GMP compliance."
- see the Genzyme announcement