The FDA's usual facility inspections have been on hold for months because of COVID-19—and pharma isn't happy. Now, after hearing calls from all levels of the drug industry, the agency says it will kick off inspections again. But it's far from a full-scale restart.
The FDA will resume "prioritized" domestic manufacturing inspections the week of July 20 after a four-month moratorium on most on-site walkthroughs, FDA Commissioner Stephen Hahn, M.D., said in a release Friday.
However, a troubling uptick in new COVID-19 cases and deaths means the agency will weigh local virus activity when deciding which sites to inspect, and that fact had analysts questioning the FDA's announcement.
In a sign of "chaotic federal messaging," Cowen analysts said in a Friday note, the FDA will draft its own risk criteria, based on local and state infection data, to pick and choose those facilities. And Hahn warned the agency would need to see a major shift in new COVID-19 cases before resuming operations fully.
"Resuming prioritized domestic inspections will depend on the data about the virus’ trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments," Hahn said. "In order to move to the next phase, we must see downward trends in new cases of COVID-19 and hospitalizations in a given area."
Meanwhile, as a safety measure for employees, Hahn said investigators would pre-announce their visits rather than making unplanned inspections. The only exception to that rule will be on retail tobacco sites "as they are undercover operations where the retailer is unaware an inspection is taking place," Hahn said.
The FDA's partial green light on inspections comes months after the administration telegraphed that it was working on a "phased approach to jumpstart site walkthroughs. Previously, investigators were only running inspections on facilities determined as 'mission-critical,'" Hahn said.
The agency's interim plan might give foreign drug manufacturers hope that things will get back to normal.
During a Senate Finance Committee hearing in early June, CEO David Light of independent testing lab Valisure warned that a slowdown in on-site inspections strained regulators' ability to ensure the quality of U.S. medicines.
"Manufacturing problems that arise from the escalated production of drugs [tied to COVID-19] and a lack of FDA inspectors on the ground at foreign plants could produce a domino effect for years to come," Light said. "The lifecycle of a drug in the supply chain is many years, and it could be many more before significant and serious issues are found, let alone addressed."
Meanwhile, foreign manufacturers have previously asked the FDA to consider alternative measures to inspect their facilities, arguing that a ban on most inspections hindered their ability to distribute key drugs.
In mid-April, major Indian pharmaceutical companies pleaded with the FDA to conduct "desk reviews" or virtual facility inspections during the pandemic in order to "ensure the continuous supply of much-needed drugs in the United States."
In a letter obtained by Fierce Pharma, the Indian Pharmaceutical Alliance asked for virtual reviews of facilities that are new, are slated to produce a new class of drugs or have completed a corrective action plan following a previous inspection failure. Among the alliance's members are India's largest drug manufacturers, including Cipla, Cadila, Dr. Reddy's Laboratories and Abbott India.
The group also requested the FDA consider recognizing inspections by foreign regulators and temporarily waiving on-site inspections "based on past inspection history and the critical nature of products, such as drug shortages or products that do not currently have generic alternatives."
The FDA at the time said it had not conducted any virtual inspections but indicated "these alternative approaches to on-site inspection have provided FDA with useful information."