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House Fails to Pass 'Right to Try' Bill Due to Democrat Obstruction

House Fails to Pass 'Right to Try' Bill Due to Democrat Obstruction

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.

A revised version of the "right to try" bill faces scrutiny from the top Democrat from the House Energy and Commerce Committee, according to The Hill. 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.

"The vast majority of people" granted access to unproven treatments "are using a drug that doesn't work", he said. It had passed the Senate past year with unanimous consent.

The defeat yesterday in the House of a "right-to-try" bill was a victory for patients across the country. "We will try again, pass legislation, and bring hope to those whose only desire is the right to try to live".

"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.

Rep Frank Pallone Jr (D-NJ), ranking member of the committee, said that the GOP bill may put patients at risk by removing FDA involvement in access to experimental drugs.

The House bill does include some changes from the Senate legislation that are created to assuage concerns raised by critics and by FDA Commissioner Scott Gottlieb. About 99% of requests for such drugs are approved by the FDA. Republicans say it would give hope to patients with fatal diseases and set up safeguards to protect them. The Senate version of the bill applies to patients with "life-threatening" illnesses, which the FDA argued was too broad a category.

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"The House will not let this be the end", said Majority Leader Kevin McCarthy, R-Calif.

Proponents of right to try, which include many libertarian organizations as well as many patient groups, say that even though the FDA's application process for compassionate use has been simplified in the last decade, it may still be arduous enough to deter terminally ill patients and their doctors from applying.

So, if there's a program in place similar to "right-to-try" and most requests are granted, why the need for national legislation at all?

The "right-to-try" movement isn't being driven by concern for patients at all, but rather to protect drug companies.

But Christopher Hansen, president of the American Cancer Society Cancer Action Network, counters that the legislation would raise the risk for patients. "The legislation would also remove FDA's consultation on dosing, route of administration, dosing schedule, and other important safety measures available under FDA's current expanded access program".

These changes were meant to address several of the criticisms levied against right-to-try legislation by certain patient groups and medical ethicists, who have insisted throughout the debate that the FDA's "expanded access" program adequately serves terminally ill patients who have exhausted their options and want to try an experimental treatment.


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