Terminally ill patients would get access to experimental drugs even without the U.S. Food and Drug Administration’s permission under a measure approved by Congress that’s strongly backed by President Donald Trump.
After fits and starts over the past several months, the House on Tuesday passed by a 250-169 vote a version of the bill deemed “right to try” that the Senate unanimously approved in August. The legislation now heads to Trump, who touted the measure in his first State of the Union address in January. His interest stems from a push by Vice President Mike Pence, who championed the initiative when he was governor of Indiana.
Under the bill, patients with life-threatening diseases who have exhausted approved treatment options and don’t meet the criteria to participate in a clinical trial would be allowed to take an unproven medicine without the FDA’s say-so. The agency has run an expanded-access program and approves almost all patient requests for experimental drugs. But it does alter dosages and make other changes to about 10 percent of the applications to enhance patient safety, FDA Commissioner Scott Gottlieb said at a Senate hearing last year.
Gottlieb has previously expressed concern during the hearing about reducing the agency’s role in screening terminally ill patients’ access to experimental drugs. Last week, however, he tweeted that he supports the Senate’s right-to-try bill and “stands ready to implement it in a way consistent with the intent of Congress to promote access and protect patients.”
‘So Important’
Trump pressed Gottlieb on the topic May 11 when the president gave a speech presenting his administration’s plan to lower drug prices.
“And right to try is happening, right?” Trump said when he introduced Gottlieb during the Rose Garden event. “We have that moving? Right to try. So important.”
The House passed its own version of a right-to-try bill in March; the vote Tuesday was on the Senate’s measure. The Goldwater Institute, a libertarian think tank based in Phoenix, has pushed the issue in the states as well as nationally. Forty states have enacted their own expanded-access programs, according to the institute.
Many drug companies have been reluctant to provide experimental medications to patients for a variety of reasons. Some say they make only enough of a drug to support a clinical trial or fear that adverse effects on patients will compromise efforts to win FDA approval of those treatments. The bill Congress passed would protect manufacturers from liability but doesn’t compel them to provide unproven treatments to anyone.
A cancer advocacy group raised concern over the move to downplay the FDA’s role in allowing access to experimental medications.
“By passing this bill, Congress is endangering the safety of patients all across the country,” Ellen Sigal, chair of Friends of Cancer Research in Washington, said in a statement.
https://www.bloomberg.com/news/articles/2018-05-22/congress-gives-dying…
