The right-to-try bill, which suffered a surprise 259-140 defeat in the House of Representatives last week, is scheduled for another vote this week. The House Committee on Rules was scheduled to meet late in the day Monday to change the procedure so that it could be passed with just a simple majority, rather than a two-thirds majority, and this time approval seems likely.
The right-to-try bill, which suffered a surprise 259-140 defeat in the House of Representatives last week, is scheduled for another vote this week, perhaps as early as Wednesday.
On Monday, the House Committee on Rules was scheduled to meet late in the day to change the procedure so that it could be passed with just a simple majority, rather than a two-thirds majority, and this time approval seems likely.
Also this week, 4 former FDA commissioners who worked on both sides of the aisle expressed their opposition to the bill in a statement to the Washington Post.
“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 reference to “either bill” referred to a companion bill in the Senate.
The statement was signed by Robert Califf, MD, and Margaret Hamburg, MD, who were commissioners during the Obama administration, and Mark McClellan, MD, PhD, and Andrew von Eschenbach, MD, who served under President George W. Bush. The Washingotn Post said the joint statement is a bipartisan attempt to try to slow down the legislation.
Last week, The American Journal of Managed Care® (AJMC®) spoke with Marjorie A. Speers, PhD, executive director of the WCG Foundation, a public charity that works to ensure experimental medicines to very ill patients under the FDA's current expanded access and compassionate use programs. Speers has previously participated on a panel on this subject at AJMC®'s Patient-Centered Oncology Care® meeting in Philadelphia, Pennsylvania.
Speers told AJMC® she did not think the bill added much beyond the FDA's current expanded access program
Last week, patient groups remained unconvinced about the bill, as well—75 of them sent a letter to House Speaker Paul Ryan, R-Wisconsin, and Minority Leader Nancy Pelosi, D-California, to protest the bill.
On Monday, Representative Frank Pallone, D-New Jersey, ranking member of the House Energy and Commerce Committee, put forth a substitute amendment in an effort to kill the bill as it currently stands—HR 5247, the "Tricket Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018"—and restore some FDA oversight and patient safety reporting. Pallone has opposed the bill.
The bill is supported by House Energy and Commerce Committee chairman, Greg Walden, R-Oregon, and chair of the health subcommittee, Michael C. Burgess, MD, R-Texas. Both had endorsed the updated version of the legislation, saying that it incorporates concerns raised by FDA Commissioner Scott Gottlieb, MD, and others.
The bill was pushed by Vice President Mike Pence, who signed a similar bill when he was governor of Indiana, and touted by President Donald Trump in his State of the Union address.