Drugs

FDA’s Lighter Enforcement May be Ending: Attorney

Attorney Douglas Farquhar (Hyman, Phelps & McNamara) says the current situation in which a larger than usual percentage of OAI (official action indicated) drug company inspections results in the exercise of FDA enforcement discretion may not continue. Writing in his firm’s FDA Law Blog, Farquhar reports on a presentation by CDER Office of Quality Surveillance director Jennifer Maguire at a recent GMP (good manufacturing practice) conference with data from 163 agency inspections from the beginning of 10/2022 to the end of 3/2023 conducted at drug manufacturing facilities (excluding compounders) that were classified as OAI.

Maguire reported that 26% of the OAI inspections resulted in Warning Letters, 19% led to Import Alerts, 24% resulted in regulatory meetings with FDA, and 29% resulted in agency enforcement discretion, a decision not to take enforcement action.

“The large percentage of OAI inspections resulting in the exercise of regulatory discretion is unusually high,” Farquhar writes. “Lest we grow too optimistic though, industry should be aware that this larger-than-historical number of what is a favorable disposition may not be a trend that will continue. It is believed that many of the inspections conducted during this period were of facilities producing essential medicines, such as Covid-related medications, for which FDA did not want to create or exacerbate product shortages.”

The post says Maguire also gave FDA figures on how many essential medicines were totally or partially manufactured in countries other than the U.S. She reported that only 11% of the finished drug products were manufactured overseas, although 92% of the active pharmaceutical ingredients for those drugs were either totally or partially manufactured in foreign countries.

Of facilities manufacturing essential medicines deemed to be the product of complex manufacturing processes, Maguire said, 68% were located in the U.S., the EU, or the UK. For facilities manufacturing essential medicines deemed to be non-complex, 60% were located in those countries, she said.

“These figures confirm that although the vast percentage of active ingredients of important pharmaceuticals comes from overseas,” Farquhar concludes, “the actual manufacturing of finished dosage form drugs occurs in the United States or Europe (broadly defined to include the UK).”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome