The FDA has decided that the risk of inspectors crossing paths with COVID-19 is greater than the risk to consumers of drugmakers failing to meet FDA standards and putting poor quality drugs on the market. The agency has decided to halt inspections of all foreign drug manufacturers after earlier putting inspections in China on hold.
The FDA Tuesday said it will consider “mission critical” inspections on a case-by-case basis but otherwise is postponing foreign inspections in April. Instead, it will rely on help from regulators in other countries, testing products at the border for safety and wielding authority to deny entry to drugs considered defective or unsafe.
Already this year, the agency has banned drugs from manufacturers in Bulgaria, China, Denmark, Germany, India, Mexico and Venezuela. Just this week it banned drugs and products from a Chinese company called Hangzhou Linkeweier Daily Chemicals Co. that included faulty antibacterial wipes. But bans generally stem from plant inspections.
While the measures may provide some help in keeping defective drugs from the U.S., the FDA acknowledged it does nothing for drugmakers who are awaiting plant inspections to gain approval to launch new drugs for the U.S.
“We are aware of how this action may impact other FDA responsibilities, including product application reviews,” the agency said in a statement. “We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government. We stand ready to resume foreign inspections as soon as feasible.”
Given the situation, the decision to halt inspection does not surprise lawyer Chad Landmon, chair of the FDA practice in Connecticut office of law firm Axinn. Assuming it is short-lived, he said in an email, there should not be a big concern over compliance and safety issues.
"That being said, FDA’s decision will likely delay approval of drug applications, particularly for generic pharmaceutical products," given that many APIs and finished dosage forms are made overseas. And those delays "may have a negative impact on the overall cost of drugs given the important role that generic drug products play in reducing the overall costs of drugs," he said.
The agency did not say how many inspections were on the books for the month, whether routine, new product or high-risk. When it announced last month that it was halting inspections in China, it said it averaged about 500 inspections a year in the country, an average of 41 a month, mostly for devices and food and drugs.
The FDA said it will get back at it just as soon as it is “feasible.”
“As this remains a dynamic situation, we will continue to assess and calibrate our approach as needed to help advance federal response efforts in the fight against this outbreak,” its statement said.