The US Food & Drug Administration (FDA) is now intending to increase the use of unannounced inspections at foreign manufacturing facilities.
This regulatory change covers sites producing everything from essential medicines, medical products and foods that are manufacturing items made for the American market.
The uptick in inspections follows the agency's Office of Inspection and Investigations Foreign Unannounced Inspection Pilot programme, which will be conducted in India and China.
The FDA is introducing this scheme to ensure that foreign companies receive the same level of regulatory oversight and scrutiny as domestic companies.
According to the FDA's Commissioner, Martin Makary, "foreign companies have enjoyed a double standard," as they are "given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning."
The scheme, which Makary calls "a key step for the FDA," is part of a broader strategies to get foeign inspections "back on track."
Currently, the FDA conducts around 12,000 domestic inspections and 3,000 foreign inspections each year — with foreign firms getting weeks to prepare as opposed to US manufacturers, who undergo frequent, unannounced inspections.
According to the regulator, foreign inspections find more than twice the amount of deficiencies than domestic inspections do.
With this regulatory shift, the FDA hopes to ensure the safety, quality and legitimacy of pharmaceutical products entering the US and expose bad actors who are "falsifying records or concealing violations."
“The FDA’s rigorous, science-based global inspections of manufacturing facilities ensure that the food and drug products that enter the US marketplace, and the homes of American consumers, are safe, trusted, and accessible,” said FDA Assistant Commissioner for Inspections and Investigations Michael Rogers.
“These inspections provide real-time evidence and insights that are essential for making fact-based regulatory decisions to protect public health.”