This weekly column offers opinions on the latest pharmaceutical industry news.
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.
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