Saturday, August 24, 2019

Saturday, August 24, 2019

Republican senators introduce innovation-driven drug-treatment bill; brace for resistance from FDA


Michael F. Cannon, director of health policy studies at the Cato Institute  

Two Republican senators recently introduced a bill they claim would combat U.S. drug shortages and drive down the prices of drugs and medical devices by allowing patients to select treatments approved in other countries.

The bill, sponsored by Sen. Ted Cruz (R-TX) and Sen. Mike Lee (R-UT), is called the Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act, or the RESULT Act. Michael F. Cannon, director of health policy studies at the Cato Institute, a libertarian think tank headquartered in Washington, D.C., said he likes the bill but he does not anticipate the FDA's support.

‘’The biggest problem with the FDA is that it denies Americans their choice of medical treatments,’’ Cannon told the FDA Reporter. ‘’Allowing patients to choose treatments approved by other countries can restore Americans’ right to choose their course of treatment. We can expect the FDA to do whatever it can to block approval of drugs approved by foreign regulatory bodies precisely because the FDA does not want competition. But foreign competition has been good for consumers in all other areas of the economy. It will be good for consumers to force the FDA to compete."

The RESULT Act would give the FDA 30 days to approve or deny an application. Cannon predicts the government body will base its argument on safety concerns, to which he presented another viewpoint.


U.S. Sen. Ted Cruz (R-TX)  

‘’Critics of this proposal take a narrow view of safety," Cannon said. "They will complain that speedier drug approvals will expose patients to greater risk. But the greatest risks patients now face are from the FDA delaying and discouraging beneficial new therapies. This proposal will reduce harm to patients by striking a better balance between both types of risk. This is a welcome proposal, but it is only a small step toward restoring the right of patients to choose their medical treatments. Government has no legitimate authority to block patients from taking drugs they want to take, any more than it would have the authority to force patients to take a drug they do not want.’’

Cruz echoed the same sentiment as he introduced the bill.

“We need to tear down the barriers blocking a new era of medical innovation, and the primary inhibitor is the government itself," the senator was quoted in a press release. "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. For this reason, I have introduced this legislation to reform the FDA and champion innovation. Our legislation will unleash life-saving drugs and devices in the United States, help mitigate critical drug shortages in the U.S., and put downward pressure on the prices of medical devices and drugs as well.’’

“Much broader reform of the FDA is needed, but this common-sense legislation would at least help some of the most vulnerable among us get the life-saving treatments they need that are already helping people in other countries,” Lee added in the press release.

Organizations in this Story

Cato Institute

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FDA Reporter