On May 22nd, the House voted to approve a version of “right-to-try” legislation. The bill passed by a vote of 250-169. The bill is intended to help patients with life-threatening conditions, allowing them to access medicines that the Food and Drug Administration (FDA) has not yet approved.
While the House passed the legislation, it still awaits a signature from President Trump. In the past, President Trump supported the measure, leading the public to believe he will sign the legislation into law, reported Stat News.1
For certain groups, the bill’s passage is considered a win. However, many view the bill as controversial, and the FDA has expressed concerns about patient protection. Key House Republicans, former FDA commissioners, and current FDA Commissioner Scott Gottlieb have all raised concerns with the legislation while also remaining in support of the bill.
The chairs of the Energy and Commerce Committee said in a joint statement, “Today’s vote is a beacon of hope for the patients who are desperately seeking the ‘right to try’ investigational treatments and therapies.”1
Texas was the first to pass the bill with a 142-0 vote. The impact was immediate, as patients were able to receive experimental cancer treatments not yet approved by FDA, reported Tenth Amendment Center (TAC).
The legislation would allow drug makers to share treatments with patients that have life-threatening conditions, even if they have not been granted FDA approval. However, the treatments must be in “active clinicals, and must have cleared initial preliminary testing.”1 Patients looking to utilize treatments that do not have FDA approval must have exhausted all their other options. Additionally, the legislation does not prevent drug makers from charging patients nor does it obligate the drug makers to provide the treatment.
Previously, House Republicans created a more detailed version of the policy which included input from supporters, drug makers, and FDA. However, that version would have limited the opportunity to patients who are terminally ill.
Gottlieb recognizes that the FDA will have to work harder to protect patients under the new bill. In a statement, the White House said, “The Administration believes that treatment decisions for those facing terminal illnesses are best made by the patients with the support and guidance of their treating physicians.”1
Those who object the legislation fear that sales representatives could take advantage of desperate patients, which would weaken or undermine the FDA’s authority. Furthermore, opponents highlight that FDA already has a system in place for granting terminally ill patients access to experimental therapies, meaning that the ‘right to try’ bill is unnecessary.
Pearl Pathways is all about accelerating life science product development. Our talented team focuses on completing critical research, ensuring high quality and efficient manufacturing of products, accelerating global product registrations, and keeping our clients up to date on current regulatory and quality compliance trends and best practices for life science product development.
1https://www.statnews.com/2018/05/22/house-vote-right-to-try/