Coronavirus Relief Act Gives Drug Makers New Sway Over FDA
By David S. Hilzenrath, Project on Government Oversight:
Last year, based on growing concerns about the safety of certain sunscreens, the Food and Drug Administration (FDA) published a plan of action.
It proposed concluding that, for two sunscreen ingredients, the risks outweigh the benefits, and it proposed declaring that there was insufficient data to support the safety of a dozen others—for example, one that has shown up in blood plasma, amniotic fluid, urine, and breast milk.
It proposed restricting properties of spray sunscreens to reduce the risk of inhaling them and suffering lung disease, and it proposed requiring that many sunscreens meet a stricter standard for protection against ultraviolet radiation.
It said it wanted to eliminate “potential confusion permitted by the current labeling regime,” under which a product labeled with a higher sun protection factor or SPF can provide “inferior protection” than one with a lower SPF because it filters a narrower spectrum of ultraviolet radiation.
The FDA’s proposal was apparently derailed by the coronavirus.
More specifically, by part of Congress’s response to the pandemic: the economic relief legislation known as the CARES Act, passed in late March.
While Americans were focused on a deadly plague and its devastating fallout, Congress fundamentally altered FDA oversight of thousands of drugstore items.
Little-noticed provisions of the CARES Act gave manufacturers new sway over the consumer protection agency and streamlined the process by which the FDA makes decisions about so-called over-the-counter or OTC drugs—products marketed for personal health and sold without a prescription.
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“User Fees”
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While the CARES Act requires the FDA to negotiate with industry, it requires the agency to “consult” with others, such as “representatives of patient and consumer advocacy groups.” In the realm of prescription drugs, the so-called patient advocacy groups the FDA consulted the last time user fees came up for renewal generally had ties to the pharmaceutical industry, POGO’s 2016 “Drug Money” investigation found.
The FDA and manufacturers have for years been laying the groundwork for adoption of user fees for over-the-counter products. In 2016 and 2017, they held a series of meetings on the subject. Industry participants included Procter & Gamble, Bayer, Sanofi, Johnson & Johnson, and a trade association, the Consumer Healthcare Products Association.
The plan the FDA and industry developed set out “performance goals” for the agency to meet under an anticipated user fee regime, including what the document describes as “substantially shortened timeframes” for the FDA to act on requests from manufacturers of over-the-counter drugs.
“This goals document represents the product of FDA’s discussions with the regulated Industry, and consideration of input by public stakeholders,” the document, called a “commitment letter,” says.
The performance goals “are important for facilitating timely access to safe and effective medicines,” the document says.
The plan the FDA and industry developed was contingent on action by Congress. Now that Congress has acted, the FDA plans to follow the performance goals in that document, FDA spokesman Charlie Kohler said in an email to POGO.
Diana Zuckerman, president of the National Center for Health Research, said the commitment letter “does not seem appropriate.”
“Performance goals should include at least as much attention regarding evidence of safety or effectiveness as it does to the issues that industry cares the most about,” Zuckerman said by email.
Historically, industries have embraced user fees as a means of reducing regulatory delays. For Congress, getting companies to pay for regulators’ salaries has been an easier pill to swallow than spending taxpayer dollars or adding to federal budget deficits.
The new user fees will enable the FDA to increase its budget and staffing for overseeing nonprescription drugs.
In the 2016 slide presentation, the FDA said it was spending just $8.2 million a year and had the equivalent of only about 30 full-time employees to oversee “hundreds of thousands of products consumed – in many cases, on a daily basis – by millions of Americans.”
The FDA compared the $8.2 million to what it said was the $8 million cost of producing “the ‘Blackwater’ episode of the hit TV series Game of Thrones.”
According to the industry’s Consumer Healthcare Products Association, over a five-year period, the user fee program will generate more than $130 million in fee revenue for the FDA.
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