Saturday, 22 September, 2018

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

Marianne Goodland with Colorado Politics and Jesse Paul of the Denver Post Marianne Goodland with Colorado Politics and Jesse Paul of the Denver Post. Bente Birkeland Capitol Coverage
Anna Jefferson | 15 March, 2018, 00:45

The measure strikes a balance between safety and providing "hopeful news for patients desperately seeking the right way to try" experimental treatments, said Energy and Commerce Chairman Greg Walden of OR and Michael Burgess of Texas, another top panel Republican. GOP chair eyes opioid bill vote by Memorial Day Committee chairman aims for House vote on opioid bills by Memorial Day Dems push for hearing on funding gun violence research MORE (R-Ore.) had been clear that changes to the legislation - a revised bill which was unveiled in a press release early Saturday morning - were coming.

Almost 40 patient advocacy groups had argued that the measure would "likely do more harm than good" in a letter in early February. The NYU School of Medicine Working Group on Compassionate Use and Pre-Approval Access, for instance, has argued that because the FDA approves 99 percent of expanded access applications, there's no reason to cut the agency out of the process.

Under the bill, if a doctor and drug maker agree to let a patient with life-threatening ailments try an experimental treatment, the federal Food and Drug Administration would no longer need to consent.

"The vast majority of people" granted access to unproven treatments "are using a drug that doesn't work", he said.

As noted above, the House version of the law would require any drug used have gone through at least phase I of an FDA clinical trial.

Walden and Burgess announced on March 10 that they'd added several others layers of regulatory compliance atop the more loosely written Senate bill that passed last August. Manufacturers would still not be required to provide their pharmaceuticals. GOP leaders could revisit the measure, perhaps after changing it.

The former is the language FDA Commissioner Scott Gottlieb recommended in October testimony before the House Energy and Commerce Subcommittee on Health.

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New Jersey Rep. Frank Pallone, top Democrat on the House Energy and Commerce Committee, said the measure is risky, unneeded and "provides false hope to patients". Republicans say it would give hope to patients with fatal diseases and set up safeguards to protect them. The FDA would have to be notified of the decision and of any problems that occur.

Holly Fernandez Lynch, a bioethics expert at the University of Pennsylvania, said the FDA acts as clearinghouse for useful information across companies, so cutting them out of the request process could be harmful.

But Christopher Hansen, president of the American Cancer Society Cancer Action Network, counters that the legislation would raise the risk for patients.

"While this version of the legislation includes patient safety improvements compared to previous versions of the legislation, we reiterate our concern with creating a secondary pathway for accessing investigational therapies outside of clinical trials that would remove FDA approval and consultation, and would not increase access to promising therapies for our patients because it does not address the primary barriers to such access", the groups wrote.

Critics said the measure misleadingly suggests the FDA is the bottleneck to providing the experimental treatments.

"FDA provides helpful information about dosing, or safety monitoring, or something that should be disclosed", she said.

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