Ted Cruz, Mike Lee push FDA to ‘automatically’ approve drugs used in ‘trusted countries’
Fox News
Senators Ted Cruz, R-Texas, and Mike Lee, R-Utah, are introducing legislation Tuesday that would allow the FDA to quickly approve drugs and medical devices for use in the U.S. if they have already received approval from “trusted countries.”
The bill, The RESULT Act, has a companion bill in the House of Representatives, introduced by Rep. Chip Roy, R-Texas, the lawmakers told Fox News Digital. The legislation would amend the Food, Drug and Cosmetic Act to allow the FDA to automatically approve any medicine, medical device, or therapy that has already been approved by at least one from a list of specified countries.
The list of “trusted countries” includes the U.K., EU member countries, Israel, Australia, Canada and Japan.
“Healthcare decisions should be made by patients and their doctors – not government bureaucrats,” Cruz said in a statement to Fox News. “We should allow patients to use life-saving drugs, devices, and medical therapies that other countries are successfully using. This is a common-sense advance in healthcare policy that would go a long way to moving America from a bureaucratic takeover of healthcare toward a patient-centered system.”
Receiving FDA approval for a new medical product is a cumbersome process that can take years before a new drug is allowed to reach the market.
While some drugs are allowed to take the FDA’s accelerated pathway allowing temporary approval based on early promising results, most must go through the full approval process.
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“The American people should not have to wait years and years for bureaucrats at the FDA to sign off on medicines that are already approved in other trusted countries,” Roy said in a statement. “This bill would cut through another wall of red tape that separates Americans from care, which means taking power away from the pencil pushing gatekeepers and putting it back where it belongs — the doctor-patient relationship.”
Cruz, Lee, and Roy have introduced versions of the RESULT Act multiple times in the past, most recently in 2021.