Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018

Floor Speech

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Ms. MATSUI. Mr. Speaker, I thank the gentleman for yielding to me.

Mr. Speaker, I rise in opposition to H.R. 5247, the so-called right- to-try legislation. This bill does not give patients the right to try; rather, it gives patients the right to request, which fails to address real barriers to accessing experimental drugs such as drug costs or company restrictions.

I will reiterate that patients already have the right to try through an expedited process that approves 99 percent of requests it receives. This legislation, however, fails to recognize that, if a patient is denied access, it is usually because a drug manufacturer says no due to manufacturer concerns about safety or side effects, not because the FDA denied a request.

I know, like everyone else, I have heard from many constituents suffering from terminal illnesses such as ALS who are desperate for cures; and I believe that every single one of us in this Chamber has confronted, in some way, a family member--mother, father, spouse--who had, heartbreakingly, an illness that had no cure. We have gone through the process many times, and I think we all have felt desperate from time to time.

However, having said that, just because a person at the end has no hope, to try something that might make things worse so you cannot go on to a more peaceful resolution would be hurtful not only to the patient, but to the family.

Opening up unregulated pathways to drugs after only a phase 1 clinical trial may expose patients to severe and unpredictable side effects. This bill would prevent FDA from documenting these side effects and, worse, would prevent FDA from protecting other patients from a similar fate.

When a loved one is in pain, the last thing a family wants is to cause further suffering. We need clinical trials to ensure drugs are safe and effective and to find real cures for patients, and we need the FDA to be a part of the process as a matter of patient protection for all.

Rescinding any FDA oversight on unproven therapies that have not undergone multiple clinical trials is a slippery slope. The expedited process we have now is working, and I cannot support a bill that offers a ``right to ask'' alongside proposals that could be dangerous for all.

Mr. Speaker, I urge my colleagues to oppose this bill.

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