Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group
Note: Tuesday night, President Donald Trump gave his joint address to the nation. In it, he suggested that the U.S. Food and Drug Administration (FDA) prevents a host of new medications and medical devices from hitting the market.
President Trump’s claims that the U.S. Food and Drug Administration’s approval process for medical products is “slow and burdensome” and “keeps too many advances … from reaching those in need,” reflect complete ignorance about the FDA’s current regulatory schemes for ensuring that medications and medical devices are safe and effective.
For example, over the past three decades Congress has created, and the FDA has routinely used, several pathways for expediting the review and approval of promising new medications for treating serious or rare diseases. Indeed, since 2000, the FDA has reviewed applications for novel medications more quickly, on average, than its counterparts in Canada and Europe, and the vast majority of these new products were approved first in the U.S.
And most high- and moderate-risk medical devices are quickly cleared by the FDA for marketing in the U.S. without undergoing testing in well-designed human clinical trials.
The regulatory pendulum for the FDA’s review of medical products already has swung too far toward promoting speed over the rigor of evidence demonstrating safety and effectiveness. Trump’s reckless proposal to slash FDA regulations in an effort to further speed FDA’s review of medical products would dangerously undermine FDA’s approval processes and lead to countless preventable injuries, deaths and illnesses across the U.S.