Federal right-to-try legislation that would have allowed terminally ill patients access to experimental therapies without approval from the U.S. Food and Drug Administration failed to muster enough support in the U.S. House of Representatives.
Federal right-to-try legislation that would have allowed terminally ill patients access to experimental therapies without approval from the U.S. Food and Drug Administration failed to muster enough support in the U.S. House of Representatives.
In order to move forward, the bill needed two-thirds support from lawmakers but fell short with a vote of 259-140. The measure was strongly supported by President Donald Trump who offered support for it during his State of the Union Address in January. The Washington Post reported there was “spirited debate” on the bill Tuesday as supporters in the Republican-led House of Representatives argued the measure was a “last chance at survival” for patients battling terminal illnesses. Democratic lawmakers who opposed the measure said the bill would weaken regulatory protections and also failed to address “the fundamental obstacles to experimental drugs.”
Right-to-try legislation unanimously passed the Senate last year but has since stalled in the House. Republicans sought to suspend the rules on Tuesday in order to push the bill forward. Such a move does not allow for amendments to any bill and calls for a two-thirds majority in order to pass. The move irritated some Democrats who criticized Republican leadership for not taking the bill through committee, Politico reported.
Frank Pallone, the ranking Democrat on the House Energy and Commerce Committee, said the bill was “based on false premise that patients are not receiving access to investigational treatments as a result of the Food and Drug Administration,” Politico reported. Pallone also criticized the bill for providing “false hope to patients and their families that they will receive a cure to their underlying disease or condition.”
The majority of states, about 38, have already passed right-to-try laws, which prompted the federal movement. However, the idea is not without criticism. Prior to Tuesday’s vote in the House, The Hill reported more than 75 patient organizations sent letters to lawmakers voicing their opposition to the measure. 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.”
Even FDA Commissioner Scott Gottlieb has only expressed “lukewarm” support for the legislation, Politico noted. During a House Energy and Commerce Committee hearing last year Gottlieb said the right-to-try legislation was unlikely to provide any additional options that the FDA’s compassionate use program already does.
The FDA describes compassionate use as “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.”
The Post said the FDA received about 1,000 annual requests for the compassionate use program and approves about 99 percent of the cases. Many drug companies though do not want to provide those medicines to patients outside of the controls of clinical trials. The legislation that failed did not provide a mechanism to compel companies to comply with compassionate requests.
During that hearing last year Gottlieb told the legislators that most of the experimental treatments provided to terminal patients through the compassionate use program are ineffective. He said about 70 percent of all drugs offered under that program are never approved by the FDA.
Although the measure failed on Tuesday Republican lawmakers are apt to try again. The GOP may attempt to bring the Senate’s version to the floor or attach the failed bill to a larger legislative package in an attempt to pass it, Politico said.
