Congress Chooses to Protect FDA Rules Over Rights of Terminally Ill Patients

A flag flies on Capitol Hill in Washington, Tuesday, Nov. 28, 2017, as President Donald Trump meets with Senate Republican leaders. (AP Photo/Susan Walsh)

Republicans introduced a bill that would allow terminally ill patients to try unapproved or experimental medications or treatments but the legislation was defeated in a 259 -140 vote.

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In a major setback for Republicans, the House rejected “right-to-try” legislation Tuesday evening that would have allowed seriously ill patients to bypass the Food and Drug Administration to get access to experimental treatments.

The vote came after a spirited debate in which GOP lawmakers portrayed the measure, which was strongly backed by President Trump and Vice President Pence, as a last chance at survival for desperately ill patients. Democrats said the bill would weaken critical FDA protections without addressing the fundamental obstacles to experimental drugs.

Republican backers brought up the measure under a suspension of the rules, which does not allow for amendments and requires approval from two-thirds of those present to pass. The legislation failed on a vote of 259 to 140.

Democrats seldom if ever support anything that would weaken any federal agency, program, or regulation. Washington knows best what is good for you.

Rep. Frank Pallone Jr., Jr. (D-NJ), the ranking member of the Energy and Commerce Committee who vehemently opposed the bill,  said in a statement that the vote meant the House had “protected patients and supported the FDA’s continued role in approving experimental treatments that may help save a patient’s life.”

It’s true that the FDA does allow some patients to receive unapproved or experimental drugs, but why should a terminally ill patient who wants to try an experimental treatment as a last ditch lifesaving effort be forced to get approval from Washington to do so?

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The FDA’s expanded-access program, which receives more than 1,000 requests a year for experimental drugs, already approves 99 percent of the appeals. But drug companies often balk at providing experimental drugs outside of clinical trials, and the federal right-to-try legislation did not compel pharmaceutical firms to provide sought-after therapies.

“This is a right-to-ask bill, not a right-to-try bill,” Holly Fernandez Lynch, assistant professor of medical ethics at the University of Pennsylvania Perelman School of Medicine, said of the House measure.

Obviously “right-to-try” implies that the treatments in question actually exist and are available. A right to try certain treatments does not obligate anyone to provide them. As many repeatedly pointed out during the botched implementation of Obamacare, no one has a right to anything that must be coerced out of another person. “Right-to-ask” might be a better way to describe the goal of this legislation but that does not mean it is undesirable.

The House bill broadened liability protections to manufacturers and others who are taking part either in the right-to-try pathway or in the expanded-access program.

Right-to-try advocates say the legislation — by simplifying and shortening the process for obtaining unapproved drugs and by expanding and clarifying the liability protection — would have encouraged more patients, doctors and pharmaceutical firms to participate.

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Opponents callously referred to the legislation as “false hope.”

Critics celebrated its demise. “We applaud the House members who voted against the seriously flawed False Hope legislation, which would have created a dangerous, uncharted pathway for accessing experimental medications that have not been shown to be safe or effective,” said Michael Carome, director of Public Citizen’s Health Research Group, said in a statement. “The bill would have exposed vulnerable patients to risks of serious harm, including dying earlier and more painfully than they otherwise would have, without appropriate safeguards.”

It just seems strange that in a society where support for assisted suicide seems to be growing and where abortion is religiously protected as a fundamental human right, there are left leaning groups opposing a terminal patient’s right to choose to accept risks in their quest to live longer.

 

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