COVID-19: Drugmaker reviews could slow as FDA foreign inspections put on ice

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Erin McCallister Senior Manager, Health Research Institute, PwC US March 11, 2020

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The FDA has postponed most foreign inspections through April. While the agency will use other tools to monitor the safety of imported foreign manufactured medical products, the hiatus could delay the review of new drug applications for products manufactured outside the US.

According to the March 10 statement from FDA Commissioner Dr. Stephen Hahn, the agency based its decision to postpone the inspections on multiple factors, including State Department Level 4 travel advisories, the CDC’s travel recommendations and access restrictions being imposed on foreign visitors by certain countries. Hahn said he also had taken into account the health and safety of the FDA’s own employees.

“We are aware of how this action may impact other FDA responsibilities, including product application reviews,” Hahn said.

The FDA will physically examine and sample products at US borders to help ensure safety, review companies’ previous compliance histories and share information with other governments as part of mutual recognition and confidentiality agreements.

Hahn said that the FDA has been using some of these tools since February when it postponed inspections in China as the SARS-CoV-2 virus outbreak was underway in the country.

HRI impact analysis

The COVID-19 crisis has highlighted the reliance of the US medical supply chain on foreign manufacturing facilities, including the first drug shortage related to the viral outbreak.

For all FDA-regulated drugs, 28% of manufacturing facilities that produce active pharmaceutical ingredients (APIs) are located in the US, according to 2019 testimony by the FDA CDER director Janet Woodcock. The EU provides 26% of APIs while India provides 18% and China 13%.

Among finished dosage products, 47% of these are completed in the US while 18% are done in the EU, followed by 11% from India and 7% from China.

In fiscal year 2019, the FDA conducted 966 foreign inspections compared to 698 domestic inspections.

As of 2017, the FDA has a mutual recognition agreement (MRA) in place with the EU. The MRA allows drug inspectors to rely on information from inspections conducted within each other’s borders. However, the MRA is focused for now just on routine surveillance and not new drugs under review.

According to an FAQ accompanying the EU MRA, “because these inspections are based upon the application submitted to a specific human drug regulatory authority, additional coordination and assessments are required.”

The FDA has a similar MRA with the UK; it does not have an MRA with China or India.

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Contact us

Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

Erin McCallister

Senior Manager, Health Research Institute, PwC US

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