The second time proved to be the charm for the U.S. House of Representatives to pass right-to-try legislation that would provide terminally ill patients access to experimental drugs without the approval of the FDA, according to a BioSpace article.
The House approved a second bill with a 267–149 vote on Wednesday. The bill will now go to the U.S. Senate for a vote. In August 2017, the Senate unanimously passed a right-to-try bill. Last week a similar bill failed after House Republicans attempted to suspend the rules to pass the bill. Under suspended rules, the bill needed two-thirds support but supporters failed to muster enough support. The bill failed in a 259–140 vote, but supporters vowed to try to pass the bill again. Right-to-try legislation has already been approved by legislators in about 38 states.
Under the approved bill’s plan, terminally ill patients can appeal directly to manufacturers for access to experimental treatment provided the drug has successfully “gone through a small-scale clinical trial and is still under FDA consideration,” The Hill reported. Essentially, that means the treatments must have passed through phase 1 and remain in development to be considered under this legislation. Patients seeking the experimental treatments under the legislation would have to be ineligible for clinical trials and have tried all other available treatments, The Hill added.
Right-to-try legislation has been wholeheartedly supported by President Trump, but many advocacy groups have expressed concern over the practice. Opposition to right-to-try has largely centered on safety concerns. The patient groups expressed concerns over removing the FDA from the process. In the letters, the groups also said the legislation would not “increase access to promising therapies for our patients because it does not address the primary barriers to such access.”
Prior to Wednesday’s votes, four former heads of the FDA spoke out against the bill. Robert Califf and Margaret Hamburg, who both served as FDA Commissioner under President Barack Obama, and former George W. Bush commissioners Mark McClellan and Andrew von Eschenbach, said the right-to-try legislation could “erode protections for vulnerable patients,” The Hill reported. The commissioners said removing the FDA from the process opened the door to safety concerns. Additionally, the commissioners said there is no evidence the federal legislation would actually provide extraordinary access to the experimental drugs. That’s because some drug companies do not want to provide access to their experimental treatments outside the control of clinical trials.
The FDA already has a compassionate use program. That program, as described by the agency, is “a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases or conditions. Such investigational drugs have not yet been approved by the FDA, and they have not been proven to be safe and effective.” Following the failure of the right-to-try legislation last week the Washington Post reported that the FDA approves about 99% of compassionate use requests annually.
Source: BioSpace; March 22, 2018.