Congressman Brian Fitzpatrick, Arizona lawmaker introduce Right to Try legislation
Congress will take another swing at legislation designed to expand access to treatments for terminally ill patients.
A bill introduced Monday by U.S. Rep. Brian Fitzpatrick, R-8, and Republican Andy Biggs, of Arizona's 5th Congressional District, aims to protect doctors and pharmaceutical companies from liability if a terminally ill patient is harmed by an experimental drug administered when there is no other alternative treatment.
The Right to Try Act of 2017 is companion legislation to a U.S. Senate bill introduced last month by Republican Sen. Ron Johnson, of Wisconsin.
"The Right to Try Act opens the opportunity to trial-stage care and establishes the freedom for patients and their doctors to try therapies where the benefits far outweigh the risks," said Fitzpatrick. "Americans — our constituents — should have every opportunity to fight for their life, or the life of their loved one."
Thirty-three states have passed Right to Try laws that supporters say provide ways around an overburdened FDA system that takes too long to grant approvals for experimental drugs. Similar bills have been introduced in Pennsylvania and New Jersey but have not made it to each governor's desk.
"In November 2014, Arizonans passed a state version of Right to Try with nearly 80 percent of the vote, which demonstrates that giving patients access to a potentially life-saving drugs has strong bipartisan support," Biggs said in a statement. "Right to Try now needs to be enacted at the federal level. Americans facing a terminal illness should be allowed to try all options that could save their lives, and our bill will give power to those patients."
Any patient seeking access to experimental treatments can currently make the request, but supporters of the Right to Try bill say the paperwork can take hours to fill out and far too long to approve. Under the state Right to Try laws, a patient's physician files a request directly to a pharmaceutical company for an experimental drug or treatment, instead of the FDA.
The request applies to products that have passed through Phase 1 of the FDA's approval process and have not been cleared for commercial distribution. In addition to liability protection, the proposed bills also say that outcomes from the use of an experimental drug or device cannot be used by the FDA to delay or adversely impact the product's review or approval.
Some experts, like Alison Bateman-House, an assistant professor of bioethics at New York University's School of Medicine, say that the intentions of Right to Try are benevolent but can ultimately cause more harm than good.
"It's a very obvious, clunky solution that carves one particular thing out from the FDA," said Bateman-House. "When I show it to people in the medical field, they sort of laugh at it. It doesn't make any sense to take a chainsaw when you need an X-Acto knife."
"The argument that the FDA is an obstacle is fallacious," Bateman-House said. "They have approved more than 99 percent of requests for experimental drugs. The FDA also never publicly says how long it takes people to get answers. I have been in the field for several years and have not heard people say the holdup is at the FDA. Usually the holdups are from pharmaceuticals and hospitals who want to dot their legal i's and cross their t's."
Sen. Johnson introduced a similar law in 2015, which also had a companion bill in the House of Representatives. Patients rights groups pushed for their passage, but the bills ultimately failed. According to Bateman-House, one positive outcome from the attention to experimental drugs was the FDA's decision to streamline the paperwork.
"People were saying it took them more than 100 hours to fill out the application," said Bateman-House. "What I suspect happened was people answering all of the questions, when they only needed to answer six. The FDA took those six questions and put them in a separate document, and now it only takes about 45 minutes to complete."
Fitzpatrick's congressional district includes Bucks County and part of Eastern Montgomery County.