Smokescreen? FDA Won’t Say How It Spends User Fees

Smokescreen? FDA Won’t Say How It Spends User Fees

  • March 6, 2024

Michael Chamberlain, RealClearHealth

The Food and Drug Administration (FDA) is funded by Congress, but it also collects “user fees” from regulated industries to fund testing and regulation of those industries’ products. By law, fees from the dairy industry must be used only to ensure dairy products are safe – they can’t go toward overseeing the safety of cold medications.

Of course, agencies can still spend the funds on a range of permissible activities related to the industry’s activities. While most agencies rely on at least a portion of their appropriations from Congress to operate, providing increased transparency and accountability into expenditures, the FDA’s Center for Tobacco Products (CTP) is unique in being entirely user-fee-funded. The Center’s statutory mandate is to regulate the tobacco industry, whose products are expressly authorized under law, in an efficient, lawful, and objective manner. But is this really how those user fees are being spent? The agency isn’t sending tobacco user fees to special interest organizations whose raison d’etre is to put the entire tobacco industry out of business, is it?

That should be a simple question, but it’s one the FDA won’t willingly answer. When the agency would not honor a FOIA request last summer for this basic information, Protect the Public’s Trust (PPT) was forced to take the FDA to court. Seven months later, our wait continues. Remarkably, it took roughly five months for the FDA to wrap their heads around our request. Two months later, we still await the first production of what FDA reports is 1,685 documents that respond to our search criteria.

Despite a judicial order to the agency in November to produce the documents and a subsequent December status report, FDA continues to drag its feet. Specifically, the agency said it had completed collection of the documents and would process them, which, it said, “typically takes around 2–4 weeks to complete.” Six weeks later, in a January 29 status update, the agency requested two additional weeks, or more, to process our records. FDA may just as well have waited the four days to officially line their filing up with Groundhog Day.

Access to user fee data may be the key to unlocking the agency’s true motivations – and whether prohibitionist special interests, such as those funded by billionaires like Michael Bloomberg, are in fact, the real decision-makers driving the agency’s policy agenda.

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