Energy and Commerce Ranking Member Frank Pallone, Jr. (D-NJ) delivered the following remarks during House Floor consideration of H.R. 5247, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018:
Mr. Speaker, I rise today in opposition to H.R. 5247, or the Right to Try Act of 2018.
Supporters of this legislation have claimed that it will provide seriously ill patients who have exhausted all of their available treatment options access to experimental therapies free from the barriers of FDA oversight. While it is understandable that someone suffering from a disease that has no more options would want to try anything that could help them fight their disease, this legislation delivers the false hope to patients and their families that they will receive a cure to their underlying disease or condition. In fact, this legislation provides patients and their families nothing more than the right to ask a manufacturer for access to early stage unproven treatments.
Like other so-called “right-to-try" proposals, H.R. 5247 is based on the false premise that patients are not receiving access to investigational treatments as a result of the Food and Drug Administration. This is simply not the case.
Through the FDA’s existing Expanded Access program, seriously ill patients are able to request access to investigational products. The FDA approves 99 percent of all requests for investigational drugs or biologics that it receives through this program. Last year FDA received more than 15-hundred requests, and only nine were not approved.
Despite this high approval rate, supporters of “right-to-try" laws have argued that the process is too slow and burdensome. But I have not seen evidence that this is the case. In fact, FDA often grants emergency requests for Expanded Access immediately over the phone, and non-emergency requests are processed in an average of four days.
FDA has even made improvements to streamline the process. For example, FDA has revised the application for physicians to ensure that it now takes less than an hour to complete. FDA also released additional guidance to industry outlining the Expanded Access program’s requirements, and addressing common questions related to the different programs and submission process and how outcomes will be considered as a part of the review process.
Last fall, FDA Commissioner Gottlieb testified on “right-to-try" efforts and told our Committee that, “There is a perception that certain products that aren't being offered under FDA expanded access... will be offered under right-to-try. I don't see that."
As I said, the review process is working well, but this legislation would completely take FDA out of the review process. This is dangerous, and could put patients at serious risk. FDA is part of the process for a reason --- it protects patients from potentially bad actors or from experimental treatments that might do more harm than good. While FDA approves 99 percent of the treatments it reviews, it also revised applications for 11 percent of patients to improve patient safety protections. In order to protect patients, this review should continue. We must protect patients from bad actors, or from dangerous treatments that might make their lives worse.
I am extremely concerned that the legislation we are considering today is advancing a solution to address barriers to investigational treatments that do not exist and could expose seriously ill patients to greater harm instead of the greater access that they are looking for. The true barrier to any expanded access is the determination by the manufacturer as to whether or not they will provide access to their product that is under development. Nothing in the legislation before us today would compel a manufacturer to grant access upon request.
Further, H.R. 5247 would allow patients access to investigational treatments that have only completed a Phase 1 clinical trial. That is an extremely small trial that does not determine the effectiveness or potential side effects of a drug. Access at this stage in the development could expose patients to untested products and further harm, and result in delaying access to a treatment that may be more appropriate and more beneficial for their underlying disease or condition.
H.R. 5247 also erodes important patient safeguards. It limits FDA’s ability to use clinical outcomes associated with the use of an investigational product when reviewing a product for approval if it could adversely impact its review. And it also prevents any entity from being held liable for use of the treatment.
While I appreciate the intent of the legislation, I cannot support it. The last thing I want to do is give patients false hope, and to potentially put them at risk by completely removing FDA from the review and approval process.
Finally, it is outrageous that a bill of this magnitude is being considered under a suspension of the rules. As my Republican colleagues well know, bills considered under suspension are traditionally bipartisan bills that have worked their way through the appropriate committees with overwhelming bipartisan support. This bill was never considered by the Energy and Commerce Committee. In fact, it was only introduced today! A bill with such critical patient safety implications should not be considered in this fashion.
I urge my colleagues to oppose this misguided legislation, and stand with the more than 100 organizations that have come forward expressing their concern for patients and the unnecessary risk this legislation could expose our nation’s most vulnerable to.
Thank you.
