Has the FDA Enforcement Apparatus Gone on Hiatus Under Trump?

Jul 3, 2019 | 483 Warning Letters, FDA, Inspection, Trump Administration

483 Warning Letter

By several measures, Food and Drug Administration (FDA) enforcement activities have plummeted since President Trump took office.

From monitoring clinical trials and approving medicines and vaccines to ensuring the safety of blood transfusions, medical devices, groceries and more, the FDA is one of the nation’s most vital watchdogs. In fact, some have said the agency regulates up to 25% of the U.S. economy. However, Science Magazine has found the FDA’s enforcement actions are on a steep decline.

For example, issuance of warning letters, a key tool for keeping dangerous or ineffective drugs and devices and tainted foods off the market—have fallen by 33% reports Science Magazine. Likewise, 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 by more than 66%.

Follow the link to learn more from the source.  TrialSite News will initiate a monitoring of this situation to determine how accurate this news is. President Trump likes to often classify news as “fake,” but if this is in fact real than there is a reason to be concerned.


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