Senate Approves ‘Right to Try’ Legislation Barring Federal Intervention in State Laws

Senate Approves ‘Right to Try’ Legislation Barring Federal Intervention in State Laws
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The Senate on Thursday easily passed legislation that aims to help terminally ill patients access experimental treatments under so-called “right to try” laws.

The legislation, from Sen. Ron Johnson (R-Wis.), would keep the federal government, including the Food and Drug Administration, from interfering when a terminally ill patient seeks access to experimental treatments that haven’t yet received FDA approval, subject to several specific conditions. It is an updated version of a January bill Johnson reintroduced after making the issue a priority on the campaign trail last year.

It essentially prevents the government from interfering with the dozens of so-called “right to try” laws that have already passed in more than two dozen states. It wouldn’t require drug makers to provide the drugs or ask insurance companies to cover the treatments.

The new version, which was cleared via a voice vote procedure usually reserved for noncontroversial policies, included key updates designed to assuage concerns from the pharmaceutical industry, Johnson said. Drug makers had worried that they might be liable for any problems a patient faced from taking a drug — or that such problems would threaten ongoing clinical trials.

“We’re trying to address people’s concerns in a reasonable way but making sure that we didn’t do anything that would prevent companies from actually participating and offering these types of — I hate to call them experimental treatments, but that’s what they are,” he told reporters Wednesday night.

That should help speed approval in the House, which has not yet taken up the issue.

The Pharmaceutical Research and Manufacturers of America, the industry’s main trade group, “may not endorse it, but they’ve been very cooperative in terms of coming up with language that everybody can support, and they will encourage passage in the House,” he said, adding that he’d also gotten “assurance” from House leaders about their support. “There shouldn’t be any snags,” he said.

The new version emphasizes that drug companies wouldn’t be held liable for problems patients face using the drugs and that results from those patients couldn’t be used to undermine other clinical trials. It does, however, explicitly require the companies to report any problems to FDA — and adds exemptions that would let the agency use the results if it saw a public health risk or if the companies themselves request the consideration. The new version also makes it much more explicit that the bill doesn’t create any new “entitlements” for terminally ill patients, and that companies don’t have to provide the drugs.

Johnson convinced Senate leadership to bring up his bill as part of a deal to speed approval of a separate package that will help fund the FDA. The so-called “user fee agreements” spell out how much drug and device makers will pay to support the oversight and approval process. Existing agreements expire at the end of September.

Sens. Lamar Alexander and Patty Murray, the Tennessee Republican and Washington Democrat who helm the Senate health committee, worked with Senate leadership to hammer out a deal on the package on Wednesday.

They intend to bring up the legislation on the issue that the House passed last month either later Wednesday or early Thursday, according to lawmakers, lobbyists and congressional staffers. Murray said she wasn’t expecting any amendments from Democrats.

Just hours before the right-to-try legislation passed, Johnson shared an emotional and celebratory call with Frank Mongiello, a right-to-try advocate with amyotrophic lateral sclerosis, one of the individuals for whom the legislation is named, he said.

More than 30 states have enacted legislation to eliminate legal obstacles blocking terminally ill patients from treatments that aren’t yet approved by the FDA. Proponents say these patients deserve the right to every possible treatment. Critics of the legislation argue that the laws put patients at unnecessary further risk, exposing them to potentially dangerous drugs and medical fraud.

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