Why Ted Cruz’s Ideas for "Fixing" the FDA are Insane | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Ted Cruz thinks the Food and Drug Administration is broken and he has a curious plan to fix it.

The presidential aspirant from Texas, along with fellow Republican Senator Mike Lee of Utah, recently introduced a bill called the RESULT Act that would drastically overhaul the process for approving drugs and medical devices.

Under the proposed law, the FDA would have to approve “life-saving” products for which is there an unmet medical need if those drugs or devices have already been endorsed in “trusted, developed countries,” including European Union member states, Canada, Israel, Australia, and Japan. The agency would have only 30 days to make a decision. And Congress could override an FDA rejection with a majority vote.

“We need to tear down the barriers blocking a new era of medical innovation, and the primary inhibitor is the government itself,” Cruz said earlier this month upon introducing the RESULT act, short for Reciprocity Ensures Streamlined Use of Lifesaving Treatments. “It’s past time to unleash a supply-side medical revolution, so that instead of simply caring for people with debilitating diseases, we cure them.”

“It’s a bad idea all around,” said Dr. Walid Gellad, codirector of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “The risks greatly outweigh any benefits.”

Why this idea is insane... see Pharmaguy's Insights below.