US pharmaceutical and life sciences manufacturers may be inspected by FDA once again

Erin McCallister Senior Manager, Health Research Institute, PwC US July 16, 2020

After a four-month hiatus, the FDA outlined its path to restarting domestic inspections of pharmaceutical and life sciences manufacturers as early as July 20. For a change of pace, companies will get a heads-up.

 

The FDA suspended on-site foreign and domestic surveillance inspections in March because of the COVID-19 pandemic. Since then, the agency has conducted “mission critical inspections and other activities” of US facilities to “ensure FDA-regulated industries are meeting applicable FDA requirements,” Commissioner Stephen Hahn said in a July 10 statement. The agency has been using a risk-based approach that includes remote assessments and import alerts as well as other compliance requirements.

 

But now, the FDA is set to resume inspections of some facilities next week. It will use a rating system that relies on three metrics to determine “where it is safest to conduct prioritized domestic inspections,” Hahn said. The metrics include the phase the state is in, according to the White House reopening guidelines; statistics measured at the county level to gauge the current trend; and the severity of outbreaks. The FDA did not define which benchmarks it will use to decide whether to carry out each inspection.

 

Perhaps the biggest departure from the agency’s previous approach is that the domestic inspections will be announced in advance for the foreseeable future. “This will help assure the safety of the investigator and the firm’s employees, providing the safest possible environment to accomplish our regulatory activities, while also ensuring the appropriate staff are on-site to assist FDA staff with inspection activities,” Hahn said.

 

The agency has set a goal of resuming domestic inspections during the week of July 20 but acknowledged that the situation would also depend upon rules and guidelines established by state and local governments where the inspection may be taking place.

HRI impact analysis

While the agency aims to resume domestic inspections, outbreaks are growing in many states, and those conditions could narrow the range of sites the FDA ultimately is able to inspect, at least in the short term.

 

An analysis by state of COVID-19 cases tracked by Johns Hopkins University shows that more than 30 states were experiencing upward trends in new confirmed cases as of Tuesday. When compared with the states with the most pharmaceutical manufacturing facilities, this analysis suggests that the agency could face challenges in executing its inspections, especially as some states reinstitute business closures and stay-at-home orders.

 

For example, California is home to the largest number of pharmaceutical manufacturing facilities in the US, with more than 140. On Monday, in response to growing numbers of confirmed cases, hospitalizations and deaths, the governor reinstated some closures, including that of offices in “non-critical sectors,” in a few counties.

 

At the same time, the FDA’s inspection hiatus has yet to result in significant delays for new drug approvals. An analysis by BioCentury found that despite the pandemic, the agency’s Center for Drug Evaluation and Research has approved more new molecular entities (NMEs) in the first half of 2020 than in the same period in each of the previous five years.

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Ingrid Stiver

Senior Manager, Health Research Institute, PwC US

Erin McCallister

Senior Manager, Health Research Institute, PwC US

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