Right-to-Try Bill Fails in the House

March 14, 2018

Rare Daily Staff

Legislation intended to give patients easier access to experimental therapies without needing to go through the U.S. Food and Drug Administration failed in the House of Representatives.

The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, had the backing of President Donald Trump, but was opposed by more than 80 patient groups including the National Organization for Rare Disorders.

The bill, which failed on a 259 to 140 vote, fell short of what it needed. Because the measure came to a vote under a suspension of the rules, an accelerated process that prevents the introduction of amendments, it required a two-third majority to pass.

“Terminally ill patients around the country are searching for a glimmer of hope to save their lives, but partisan obstruction has delayed passage of this legislation,” said Rep. Andy Biggs, R-Arizona, who was the original sponsor of the House version of the bill. “I’m grateful for all of my colleagues – on both sides of the aisle – who rallied together to better the lives of our fellow Americans. We must not stop trying to pass the Right to Try.” He called on House leadership to bring to a vote a Senate version of the bill that passed in August.

The bill had support from conservative groups seeking limited government including the Goldwater Institute, Freedom Partners, and Americans for Prosperity. But many patient groups opposed the legislation because they said it would weaken safety protections for patients while failing to address the true obstacles patients face in getting access to experimental therapies.

“We are relieved the bill will not be moving forward at this time and thankful for the many Representatives who voted against the creation of a less-safe, redundant pathway for accessing investigational therapies outside of clinical trials,” NORD said in a statement following the failure of the legislation. “While we opposed this bill, we strongly support increasing access to experimental therapies for individuals with terminal conditions. We hope Congress will turn its attention toward real solutions that address the current barriers to access.”

Among approaches identified by NORD were lower the financial disincentives companies face in providing their therapies through expanded access, more equitable access to institutional review board review, and requiring FDA to clarify its use of adverse events in expanded access, as well as create a structure for accepting and reviewing supportive data from expanded access.

March 14, 2018

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