FDA Enforcement Actions Drop Under Trump Administration

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The Food and Drug Administration (FDA) is responsible for monitoring and ensuring the safety of medicines and vaccines, blood transfusions, medical devices (such as joint replacements and surgical instruments) as well as food products and nutritional supplements.  It functions as one of the most important consumer watchdogs, and its mission is vital to the safety and health of all Americans.

A disturbing report recently published in the journal Science has found that FDA enforcement actions across all categories of products and devices have fallen precipitously under the Trump administration.  FDA issues “warning letters” to manufacturers to keep dangerous, ineffective or unsafe products off the market. Under the current administration, issuance of these letters has fallen by a third compared with a similar time frame under President Obama. 

“Warnings from the FDA Center for Devices and Radiological Health, which helps ensure the safety and quality of medical devices, and from some of the agency’s district offices—including Philadelphia, Florida, and New York—have dropped even more steeply, by more than two-thirds. Two district offices have not issued a warning in more than 2 years. The numbers don’t just reflect a new administration’s slow start. FDA sent significantly fewer warning letters in the second year of Trump’s presidency than in his first.”

FDA watchers have been unable to determine what is driving the decline. “Those who think the Trump administration has not succeeded in its deregulatory efforts ought to look at these data,” says Peter Lurie, an FDA executive under Obama and Trump and now executive director of the Center for Science in the Public Interest, a Washington, D.C., advocacy group. “Industry may well take the message from this that the cop is not on the beat as often.”

Especially troubling is that electronic cigarette enforcement has also declined, especially in relation to the unknown health effects related to teen vaping.  Data has shown that vaping among high school students rose 78% from 2017 to 2018. Vaping among middle school students rose 48% over the same period. Last year FDA did issue some guidance concerning restriction of some sweet vaping flavors and begin to enforce nicotine warnings and improper marketing practices.  Critics claim this is too little, too late. Tobacco-control advocates said the policy fell short. “This will fail to solve the e-cigarette epidemic,” said Erika Sward, a spokeswoman for the American Lung Association. “The FDA is continuing to kick the can down the road rather than doing what it will ultimately take to end this epidemic — removing all flavored tobacco products from the market.” Matthew Myers, president of the Campaign for Tobacco Free Kids, said Gottlieb deserves credit for focusing attention on the epidemic of e-cigarette use by children. But the “FDA’s proposed actions don’t match his strong words,” he said. “A public health crisis of this magnitude demands faster and more forceful action than the steps announced by the FDA.”

The Science article goes on to note:  

“Deregulatory pressure from the White House has had profound effects on several federal agencies, but whether and how it might explain the drop in some elements of FDA enforcement is unclear. But for some actions, including injunctions, FDA requires Department of Justice (DOJ) cooperation. Two people with personal knowledge of FDA enforcement, who decline to be named for fear of reprisals, say that under Trump, DOJ has blocked numerous strong injunction requests from FDA. One source says it became much harder to bring new injunction cases after Trump took office.”

Our government agencies tasked with protecting the public health and welfare must receive all the support they need to function properly.  The present administration’s science denial policies, industry deregulation and failure to enforce existing laws and regulations designed to protect our health mandates citizen action.  Write to your legislators and government representatives and express your dissatisfaction and concern. The health of you and your family depends on it.

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