The U.S. Food and Drug Administration (FDA) announced they would block pharmaceutical sales if drug makers resist agency requests to interview employees or examine internal records during inspections, experts say.
Regulators will enforce a provision in the FDA Safety and Innovation Act of 2012 that says pharmaceuticals can be deemed adulterated as a result of “circumstances that constitute delaying, denying, limiting or refusing a drug inspection.”
On July 9, 2012, President Obama signed into law the “Food and Drug Administration Safety and Innovation Act” (FDASIA), which includes enhanced penalties for trafficking counterfeit drugs. Congress recently passed the “User Fee Act.” These supply chain requirements will help protect the American consumer by strengthening the protections in the pharmaceutical supply chain.
To the extent that the FDA expects answers, it puts drug maker employees in an awkward position of wanting to cooperate without being improperly forced to provide statements that could be used against the company.
Also in Tuesday’s guidance, the FDA said it understood that manufacturers sometimes needed extra time to produce requested records, “especially if the records are maintained at a different site” than the site being inspected.
That’s notable because the FDCA merely says that when visiting a manufacturing site, “the inspection shall extend to all things therein” that have reluctance to the inspection. Some attorneys feel that the FDA is looking to stretch that language so it can obtain any records at any location, as long as they’re deemed relevant to an inspection.
FDASIA’s provision on inhibiting inspections has been read to apply to traditional drug products, but it’s looking like the FDA will apply it more broadly. The final guidance said inspection rules would also cover so-called ‘outsourcing’ facilities – compounding pharmacies that register with the FDA in accordance with the Drug Quality and Security Act, which Congress passed last year after the draft of this guidance was issued.
The guidance further said it would cover “facilities subject to inspection under any of the authorities in [FDCA] Section 704,” which governs inspections of not just pharmaceutical plants but also facilities that produce or process medical devices, food, tobacco and cosmetics. This suggests the FDA wants its new inspection powers to apply universally.
The most obvious difference between the draft and final versions was the introduction of numerous examples of what the FDA would deem “reasonable explanations” for inhibiting inspections.
The guidance also made clear that although it’s possible that various exceptions might be accepted, there’s no guarantee. That means inspectors will carefully consider on a case-by-case basis whether explanations are accepted.
One of the guidance sections sparked attention among lawyers stating that it’s sometimes acceptable if “appropriate personnel are not immediately available to accurately answer the FDA investigator’s questions” during a surprise inspection.
That’s important because the Federal Food, Drug and Cosmetic Act doesn’t specifically obligate manufacturers to answer verbal questions during inspections, according to experts who say the FDA seems to sort of imply that such an obligation exists.
The purpose of the FDA is to protect American consumers. If the pharmaceutical companies know that the agency can inspect their records at any given moment, hopefully it will benefit us all.
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