Right-to-Try Bill Moves Forward

The Right-to-Try bill recently passed in the United States House of Representatives.
BY Kristie L. Kahl
PUBLISHED March 22, 2018
The House of Representatives has passed a controversial right-to-try bill that would give critically ill patients quick access to experimental drugs.

On March 21, the House voted 267 to 149 along party lines on the Republican-backed measure. The next step will be for the Senate — which supports the concept and passed its own version of the legislation over the summer — to consider the bill.

“We … believe that patients with terminal conditions, terminal illness, should have access to experimental treatment immediately that could potentially save their lives,” President Donald Trump said during his Jan. 30 State of the Union address. “People who are terminally ill should not have to go from country to country to seek a cure. I want to give them a chance right here at home. It’s time for Congress to give these wonderful, incredible Americans the right to try.’”

Right-to-try legislation allows patients who are terminally ill to take experimental drugs that have met the goals set for them in phase 1 testing within the Food and Drug Administration’s (FDA) review process. That’s an early phase of testing, and these drugs are considered experimental. The legislation is designed to expand access to these potentially life-saving drugs years before they become commercially available — if they ever do.

Right-to-try legislation is already a law in 38 states, and under consideration in 12 more. Supporters of the bill say it is needed to quell patient fears that the federal government could decide to reverse these state regulations.

Those who oppose the bill, however, say that the use of unapproved drugs would bypass the authority of the FDA and undermine the drug development process, as well as patient safety. They also argue that the bill would not guarantee patient access to experimental drugs, because it would not require pharmaceutical companies to provide them.

Finally, bill opponents note that patients already have a route for gaining access to experimental drugs: the FDA’s compassionate-use program.

“Removing the FDA from this process is not likely to facilitate increased access to investigational therapies, because the FDA currently approves 99.7 percent of all expanded access requests submitted by physicians and companies for patients with immediately life-threatening illnesses who cannot participate in clinical trials,” said Keysha Brooks-Coley, vice president of federal affairs for the American Cancer Society Cancer Action Network, the society’s lobbying arm.

Brooks-Coley added that, when pharmaceutical companies deny requests under the compassionate-use program, it is usually for rational reasons. For example, requests might be denied if the benefits to a patient do not outweigh the risks associated with a drug, if there is not enough of the product to offer outside of clinical trials, if it is too costly for the company or if compassionate use could detract from clinical trial enrollment.

“It is important to remember that the current regulatory system for medical products and research in the United States was created as a result of serious patient harm and exploitation that occurred early in the 20th century,” said Brooks-Coley. “Clinical research protections are in place when experimental products are being tested to ensure the safe and ethical treatment of research participants. Patients seeking expanded access to unapproved therapies outside of clinical trials must be afforded the same ethical standards and protections as patients taking part in clinical trials.”

On March 12, ACS CAN and 75-plus other organizations representing millions of patients sent a letter to House leaders expressing concerns about the legislation. The groups acknowledged that patient safeguards had been added to the bill, but called for more, which mainly would have involved additional FDA oversight.

The groups included the American Lung Association, the American Society of Clinical Oncology, CancerCare, Facing Our Risk of Cancer Empowered, the Leukemia & Lymphoma Society and the National Comprehensive Cancer Network.

“We welcome the opportunity to continue constructive dialogue on ways to improve the ability of patients to genuinely and safely access both approved and unapproved lifesaving therapies,” the organizations wrote.
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