Barred OTC drugmaker calls FDA oversight 'absurd'

A Canadian over-the-counter drugmaker isn't happy with U.S. regulators. The FDA barred Pax-All Manufacturing products from the country after inspectors found numerous problems at an Ontario plant. Pax-All is working with the FDA to resolve those issues, but the company is riled because inspectors showed up in the first place.

As The Globe and Mail reports, Pax-All VP Mario Merino says "it's absurd" that the agency has targeted his company. He blames selective inspections. Pax-All has suffered "hassles and inspections" that rivals in Asia haven't, he says. "It's because we're close to them," Merino told The Globe and Mail. "It's easy for them to inspect us. They don't go (to Thailand and China)."

The FDA, of course, takes issue with Merino's characterization. Spokeswoman Shelly Burgess told the newspaper that the agency doesn't "just target one company and not others." Rather, the FDA takes "a risk-based approach depending on the level of risk involved and how severe the potential violation would be to the consumer," Burgess said. "Someone who has received a warning letter will of course try to deflect the attention away from them."

Pax-All's warning letter cited a host of shortfalls. FDA inspectors said the company hadn't cleaned or maintained equipment often enough to prevent contamination. The company failed to test products adequately and didn't assess storage conditions properly, the letter said. Inspectors also came across a fixer-upper commonly used around the house: Duct tape. Pax-All used it and cardboard to repair filling lines, the Globe and Mail reports. "These materials are not suitable ... or easily cleanable, and are not adequate for the manufacture of drug products," the letter said.

It isn't the first time the FDA has drawn fire for its foreign-inspection rate. In the wake of the heparin safety scandal a few years ago, lawmakers took the agency to task for its limited oversight overseas. Since then, the FDA has added staff and resources to inspect more foreign facilities more often--and opened its own office in China--but is limited by politics and funding, and often has to rely on local regulators' assessments.

- read The Globe and Mail piece