May 6 (UPI) — The U.S. Food and Drug Administration said Tuesday it will expand its use of unannounced inspections at foreign manufacturing facilities.
“For too long, foreign companies have enjoyed a double standard — given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning,” FDA Commissioner Martin A. Makary wrote in a release.
The FDA says its intent will be to expand the surprise inspections at non-U.S. manufacturers that produce items such as food products or essential “medical products.” Unannounced inspections, according to the FDA, will help expose bad actors and those who falsify records or conceal violations, putting American lives at risk.
Makary, a Johns Hopkins surgeon who was nominated by U.S. President Donald Trump and reports to U.S. Health and Human Services Secretary Robert F. Kennedy Jr., was confirmed at the end of March as FDA commissioner.
On Tuesday, he called the recently announced move a “key step” for the FDA as part of a “broader strategy” in order to “get foreign inspections back on track” after the COVID-19 pandemic for its over 12,000 domestic and 3,000 yearly foreign probes in more than 90 nations.
FDA officials pointed out that the change will build on a pilot program tested in China and India by the agency’s Office of Inspection and Investigations which aimed to look and see if foreign companies would get the same level of scrutiny and regulatory oversight as a U.S.-based firm.
“The FDA’s rigorous, science-based global inspections of manufacturing facilities ensure that the food and drug products that enter the U.S. marketplace, and the homes of American consumers, are safe, trusted and accessible,” stated Michael Rogers, the FDA’s assistant commissioner for inspections and investigations.
Federal officials added that continuous evaluation of policy and practices will ideally ensure the U.S. Food and Drug Administration as a “gold standard” for regulatory oversight, which also will seek to clarify existing policies for FDA investigators in ethical areas.
“While U.S. manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process,” the FDA continued.
It said despite foreign entity’s even getting an advanced notice, FDA inspectors still find “serious deficiencies” more than twice as often than during U.S. inspections.
Meanwhile, more than 70% of active pharmaceutical ingredients and more than half the finished medications consumed in the United States are produced overseas, Janet Woodcock, then-director of the FDA’s Center for Drug Evaluation and Research, said in 2020.
In 2019, the FDA’s 200 inspectors conducted some 966,000 international site visits with only 9% reported safety violations. India was the biggest offender, with violations at 17% of its inspected plants.
By March 2020, the FDA suspended inspections at thousands of international plants that supplied U.S. citizens with critical drugs and other medical supplies, which raised alarms amid the worsening COVID-19 pandemic.
Rogers, the FDA’s current number two for investigations and inspections, says its inspections provide “real-time evidence and insights that are essential for making fact-based regulatory decisions to protect public health.”
The FDA, which has limited regulatory powers, indicated that its new policy shift would “further ensure” that products destined to American shores are “safe, legitimate” and made “honestly.”
