Virus Interrupts FDA Foreign Drug Inspections

Delays due to continue through April

12.03.2020 -

Due to the increasing threat posed by the coronavirus COVID-19, the US Food and Drug Administration (FDA) has decided – after “careful consideration” – to postpone inspections of all foreign-made drugs to avoid exposing its staff to the virus.

The inspection stop declared on Mar.10 with immediate effect will apply through the end of April. It follows the halt put to inspection of drugs made in China implemented earlier at first knowledge of the corona outbreak.

Inspections outside the US that are deemed to be “mission-critical” will still be considered on a case-by-case basis, despite US travel advisories for government personal, the FDA said.

The health watchdog said it had based its decision on several factors, including the confidence it has in its ability to maintain oversight over international manufacturers and imported products using alternative tools and methods.

“When we are temporarily not able to physically inspect foreign produced FDA-regulated products or manufacturers, as an interim measure we employ additional tools to ensure the safety of products imported to the US, which have proved effective in the past, it noted.

The interim measures described by the agency include denying entry of unsafe products into the US, physical examinations and/or product sampling at the borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements and requesting records in advance of or in lieu of on-site drug inspections.

According to information provided before the delays, the FDA averages about 500 inspections a year in, or about 41 per month, mostly for devices and food and drugs

In its statement announcing the interruption in inspections, the agency said it is also aware that its actions may impact other FDA responsibilities, including product application reviews. On the regulatory front, it said it will continue working with US Customs and Border Protection to target imports that violate applicable legal requirements for regulated products.

Through its risk-based import screening tool (PREDICT), the health authority said it is able to focus its examinations and sample collections based on heightened concerns of specific products being entered into US commerce, adding that its  PREDICT screening continues to adjust risk scores as necessary throughout the COVID-19 outbreak.

While the FDA’s alternative solutions may help keep defective drugs from the US market, they will be a burden for drugmakers awaiting plant inspections to gain approval to launch new drugs for the US market, pharma industry observers commented.

The interruption in reviewing application is expected to affect in particular APIs, most of which are made outside the US. This could also lead to increases in drug products, some predict.