FDA won't say how it spends user fees

[Editor's note: This story originally was published by Real Clear Wire.]

By Michael Chamberlain
Real Clear Wire

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.

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For such a simple but important request asking to whom the agency is writing checks, the perpetual delay and baseless obstruction is astounding. Perhaps one reason is that transparency might bring unwanted scrutiny to an agency that, according to multiple federal courts, has failed to perform some of its most fundamental tasks. For example, one federal court recently found FDA has sent the tobacco industry on a wild goose chase and moved the goal posts for years, failing to process lawful applications that, by some accounts, has opened the door for a black market to take off.

Unsurprisingly, documented patterns of both inaction and overreach appear to advance a prohibitionist agenda. In August, the U.S. District Court in Washington, D.C. vacated the FDA’s “deeming rule,” and ruled it was “arbitrary and capricious” for the agency to regulate premium (generally expensive, hand rolled cigars requiring storage in a humidor). The FDA is appealing, but the ruling made it clear the agency doesn’t have carte blanch to regulate everything it “deems” to be hazardous.

Other signs are also present that not all is right with the public health agency’s tobacco research and regulation.

In April 2023, PPT filed a complaint with the FDA’s parent, Department of Health and Human Services, based on what appeared to be violations of scientific integrity in its decision-making around e-cigarettes, to the detriment of public health. Public records indicated that the FDA knowingly disseminated scientifically unfounded statements about the vaping industry that were contrary to the FDA’s own research, and that agency officials overruled their own scientists’ recommendations to authorize menthol-vapes. In this and other instances, the agency’s own data appears to contradict the FDA’s public stance on vaping products, leaving the public to wonder if political interference or major special interests are taking precedence over scientific research at the FDA. If so, the loser will be both the public’s health as well as its already deteriorating trust in the government’s public health apparatus.

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.

Michael Chamberlain is Director of Protect the Public’s Trust

This article was originally published by RealClearHealth and made available via RealClearWire.

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