Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Cruz versus FDA: Deconstructing the RESULT Act

Cruz versus FDA: Deconstructing the RESULT Act | Pharmaguy's Insights Into Drug Industry News | Scoop.it

US Senator Ted Cruz wants to change the way the Food and Drug Administration approves drugs. Indeed, the introduction of his “Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act” has sparked hot debate, says Dr Nicola Davies in her monthly FDA Blog for The Pharma Letter.

In this draft legislation, Sen Cruz proposes that Congress should be allowed to overrule the FDA if a potentially life-saving drug is rejected, and also that drugs already approved in certain developed countries, such as Japan, Canada, Australia and Israel, should be approved on a reciprocal basis.


Sen Cruz wants the FDA to be given thirty days to evaluate evidence in favor of a drug approved elsewhere in the world. Should it decide against reciprocal approval, then Congress will have the power to overturn this decision by a majority vote.


What implications will this legislation, if approved, have for the FDA’s ability to ensure that medications are safe and effective?

Pharma Guy's insight:

Related: ""Why Ted Cruz’s Ideas for 'Fixing' the FDA are Insane"; http://sco.lt/5A5tsf

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Pharma Guy's curator insight, March 28, 2016 8:06 AM

Related: ""Why Ted Cruz’s Ideas for 'Fixing' the FDA are Insane"; http://sco.lt/5A5tsf

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Why Ted Cruz’s Ideas for "Fixing" the FDA are Insane

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.

Pharma Guy's insight:

Why this idea is insane: (1) Anyone remember thalidomide? (http://sco.It/5dFcif). (2) FDA act within 30 days? Never happens. (3) Congress make decisions regarding which drugs should be approved for sale in U.S.? I don't think I need to explain why that's an insane idea.

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