The US FDA also is concerned about practices in the over-the-counter medicines space, which is seeing the arrival of several new entrants.

Cavazzoni said that the new entrants tend to be cosmetic firms stepping into the drug space, adding that even more concerning is the entry of industrial manufacturers into the drug-making business.

Many foreign OTC firms are failing rudimentary cGMP requirements by not conducting raw material, finished product and stability testing, she said.

“When we see these new manufacturers coming on board and register their facilities, it's very clear that many of these overseas manufacturers are not aware of the US requirements for testing of drugs,” Cavazzoni said at the summit.

The agency tends to play a “whack-a-mole” with product quality violations in the segment, particularly because there’s a “bit of a gap” in the FDA’s authority to inspect facilities that make OTC or monograph drugs before they enter the US.

“We have that authority for all other products, but not for monograph drugs and we have asked Congress to fill that gap,” she said.

In fiscal year 2023, the FDA issued 94 warning letters to drug manufacturing sites related to quality issues. Of those, 80% manufactured OTC monograph products, even though the sites accounted for less than 20% of inspections that fiscal year. More than half made hand sanitizer or products that could be contaminated with diethylene glycol and ethylene glycol, according to details in CDER’s FY 2023 Report on the State of Pharmaceutical Quality.

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