With drugmakers clamoring, FDA looks to restart facility inspections delayed by COVID-19

FDA
The FDA halted most on-site inspections of foreign and domestic drug manufacturers in early March. (Pixabay)

The FDA abruptly shut down its on-site facility inspections in March, hoping to keep its employees safe during the novel coronavirus pandemic. More than two months into that moratorium, drugmakers are calling for relief—and with some new guidance, the FDA shows it might be willing to accommodate.

The agency is working with the U.S. Centers for Disease Control and Prevention to develop a "phased approach" to restarting inspections of domestic and foreign drug manufacturing facilities, the administration said in a statement Monday. 

While the FDA was slim on details on how that rollout would work, experts told Cowen & Co. analysts the plan would likely continue the agency's focus on high-priority inspections taken on a "case-by-case" basis, the firm said in a Tuesday investor note.

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So far, the FDA has used volunteer teams to conduct inspections for facilities deemed "mission critical," according to Cowen. In lieu of widespread facility checks, the agency has ramped up alternative quality control methods, such as examining physical product at the border, reviewing facilities' compliance records and sharing inspection information with foreign governments.

The FDA's willingness to consider resuming on-site inspections could offer a respite for foreign manufacturers that have pleaded for an avenue to bringing their drugs and active pharmaceutical ingredients to the U.S. market.

RELATED: Indian pharmas call on FDA to perform 'virtual' facility checks during COVID-19 inspection lockdown

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 FiercePharma, 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."

RELATED: Eyeing COVID-19 shortages, FDA unleashes compounded drugs to treat hospital patients

The FDA's move to restart inspections could help drugmakers get their supply chains back in order after the U.S. has recognized shortages of critical drugs during the novel coronavirus pandemic.

In late April, the FDA said it would temporarily free hospitals to source hard-to-find drugs from compounding pharmacies to treat certain COVID-19 patients.

The FDA emphasized that its extraordinary step was designed to be temporary as the pharmaceutical supply chain faces "unprecedented disruptions" amid the pandemic to provide drugs used for patients placed on respirators.

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