The House of Representatives has passed a bill giving patients the ability to try experimental drugs and treatments that have not been approved by the FDA, this week. The so-called right-to-try bill gives very ill and terminally ill patients the right to try medicine that has passed Phase 1 of the FDA approval process for basic safety but remains in the clinical trial stage.
Righttotry.org, a cause-advocacy group, says only 3% of the millions of patients who are terminally ill – about 1,200 people – gain access to experimental drugs through the FDA’s compassionate use exception. Right to try legislation, the organization says, expands access to the other 97%.
Critics say that right-to-try legislation is little more than false hope for ill patients. They say it fails to address the real barrier to experimental treatment – drug companies.
“The fact is when a patient is denied access to an experiential treatment, it is because a company has said no, not the FDA,” said Rep. Frank Pallone (D-NJ), ranking member on the House Energy and Commerce Committee. “So let’s be clear about what this legislation is. It’s an attempt to undermine the authority of the expert public health agencies charged with reviewing drugs to ensure their safety and efficacy.”
Democrats, who are mostly against this bill, say that right-to-try legislation is not about expanding patient access, but rather an effort by conservative political action groups to undermine the FDA, and then other federal agencies after that.
Pallone’s argument seems to have been corroborated by four former heads of the FDA who issued a statement challenging the assertion that right to try legislation expands access. “There is no evidence that either bill would meaningfully improve access for patients, but both would remove the FDA from the process and create a dangerous precedent that would erode protections for vulnerable patients,” the statement read.
The statement was signed by Robert Califf and Margaret Hamburg, who served in the Obama administration, and Mark McClellan and Andrew von Eschenbach, who served under George W. Bush. The desire of the four former commissioners is to try and slow progress of the legislation down on Capitol Hill.
The House bill passed on Wednesday by a vote of 267-149. Thirty-Five Democrats voted for the measure and two Republicans voted against. A slightly different version of the House bill passed in the Senate last summer. Some type of right-to-try legislation is almost assured of becoming law.
President Trump focused on the issue during his State of the Union Address in January. “We also believe that patients with terminal conditions should have access to experimental treatments that could potentially save their lives,” he said. “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 is time for the Congress to give these wonderful Americans the ‘right to try.’”
“It is hope. It’s incredible. They’ve been talking about this for years and years and years. We’re going to get it approved. So important,” the President also said during a speech last Monday in New Hampshire.
A sentiment proponents of the legislation echoed. “It’s not false hope; It is hope. Support of this bill is compassionate. Support of this bill is fair,” said Rep. Andy Biggs (R-AZ), one of the House bill’s original sponsors.