Good manufacturing pathway needed for FDA to consider new drug approvals

SAN FRANCISCO — Six ophthalmic new drug applications were stalled by the FDA in 2016 for issues with chemistry, manufacturing and controls. Without commenting specifically on drugs not approved, one member of the FDA did relate a trend that could potentially be a contributor to holding up the approval process: New drug applications are being submitted with limited pathways through good manufacturing procedures.

Wiley Chambers, MD, speaking as an FDA panelist at the Glaucoma 360 New Horizons Forum, said, “We used to see applications be submitted with several proposed drug source manufacturers, several sterilization facilities, several drug product facilities, and it was not uncommon — is still not uncommon — for individual facilities, when they get inspected, to have … deficiencies noted and potentially be deemed to not be in compliance with good manufacturing.

Wiley Chambers

“So what used to happen is we would look at the kind of approval. Is there a pathway? Is there at least one drug substance manufacturer? Is there at least one sterilization facility? Is there at least one drug product manufacturer? As long as there was a pathway with at least one facility all the way down, we could approve the product. On the other hand, what is happening more recently is, companies are submitting new drug applications with a single drug substance manufacturer, a single sterilization facility, a single drug product. So if any one of those three fail, you no longer have a pathway. And if you don’t have a pathway to manufacturing a drug product under good manufacturing procedures, we can’t approve the product.” – by Patricia Nale, ELS

Reference:

Getting to new horizons. Presented at: Glaucoma 360 New Horizons Forum; Feb. 3, 2017; San Francisco.

Disclosure: Chambers reports he is supervisor medical officer, Division of Transplant and Ophthalmology Products, Center for Drug Evaluation and Research, FDA.