Saturday, September 22, 2018
Politics

Big patient groups urge House to defeat ‘right to try’ bill allowing greater use of experimental drugs

WASHINGTON - Dozens of patient groups urged the House to reject "right to try" legislation - scheduled for a vote Tuesday - designed to allow seriously ill patients to largely bypass the Food and Drug Administration to get access to experimental treatments.

More than 75 organizations, including the American Cancer Society Cancer Action Network, the American Lung Association and the Cystic Fibrosis Association, sent a letter to House leaders saying the bill "would not increase access to promising therapies" because it doesn’t address the main barriers to experimental drugs.

And by skirting the FDA, the letter added, the proposed right-to-try pathway would be "less safe" for patients than the agency’s existing program, called expanded access, for overseeing the use of unapproved therapies outside of clinical trials.

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The groups’ plea came as the conservative Goldwater Institute and other supporters of the bill touted it as a critical lifeline for desperate patients ineligible for clinical trials. Thirty-eight states have passed right-to-try laws, and a federal law would block the government from preventing patients from taking advantage of them.

"Right to Try provides a new path for people who are out of options," said a letter circulated by Goldwater and signed by 20 groups, including the Abigail Alliance for Better Access to Developmental Drugs, Fire Fighters with Parkinson’s Disease and Cures Within Reach. Under the legislation, strongly backed by President Donald Trump and Vice President Mike Pence, patients must first exhaust all other treatments, and the experimental drugs used must have already undergone preliminary safety testing.

The House bill, which was released Saturday by House Energy and Commerce Committee Chairman Greg Walden, R-Ore., and Health Subcommittee Chairman Michael C. Burgess, R-Texas, is similar to legislation passed by the Senate in August.

The intense, emotional debate surrounding the bills masks a fundamental question: Would a federal right-to-try law have much impact on patients?

The FDA’s expanded-access program, which receives about 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. The right-to-try legislation does not compel pharmaceutical firms to provide sought-after therapies.

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

Energy and Commerce Committee ranking member Frank Pallone Jr., D-N.J., announced his opposition to the House bill Monday, saying it gives patients "false hope" and puts them at risk by removing the FDA from overseeing use of experimental treatments.

The House bill does include some changes from the Senate legislation that are designed to assuage concerns raised by critics and by FDA Commissioner Scott Gottlieb. In congressional testimony in October, Gottlieb suggested that lawmakers limit the scope of the legislation to avoid undercutting the FDA’s drug-review process.

Under the Senate bill, for example, patients are eligible for right to try if they have a "life-threatening disease or condition." Gottlieb suggested that the category be narrowed to the "terminally ill." The House bill, taking a step in that direction, says patients would be eligible if they are likely to die in a "matter of months" or have a disease that would result in "significant irreversible morbidity that is likely to lead to severely premature death."

Republican committee aides said that the House legislation also includes more robust informed consent requirements than the Senate bill and requires that doctors immediately notify the FDA about adverse events, something the Senate legislation does not include. Both chambers’ bills would permit the FDA to consider adverse events as part of a drug-approval review, but only if such complications are "critical to determining the safety" of the drug.

The House bill broadens 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 encourage more patients, doctors and pharmaceutical firms to participate.

But Christopher Hansen, president of the American Cancer Society Cancer Action Network, counters that the legislation would raise the risk for patients. The FDA sometimes requires changes in dosing schedules and safety monitoring for patients taking part in its expanded-access program, a protection that would not be available under right to try, he noted.

In a statement, FDA spokeswoman Jennifer Rodriguez said the agency has a "strong desire to help patients facing terminal illnesses access promising experimental treatments in their fight." It has been working closely with lawmakers, she added, "to provide technical assistance as Congress works on this important issue to help ensure patients are also protected."

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