[Congressional Record Volume 164, Number 88 (Tuesday, May 29, 2018)]
[Extensions of Remarks]
[Pages E751-E752]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 TRICKETT WENDLER, FRANK MONGIELLO, JORDAN McLINN, AND MATTHEW BELLINA 
                        RIGHT TO TRY ACT OF 2017

                                 ______
                                 

                               speech of

                           HON. ANNA G. ESHOO

                             of california

                    in the house of representatives

                         Tuesday, May 22, 2018

  Ms. ESHOO. Mr. Speaker, I once again rise in opposition to the Senate 
version of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and 
Matthew Bellina Right to Try Act of 2017.
  The third time is not the charm. The House version of this bill was 
defeated when it was brought up under suspension and a week later it 
was forced through on a party line vote.
  This bill is dangerous. It will put the most vulnerable patients' 
lives at risk by using products that have not been tested for efficacy. 
It also takes unprecedented steps to undermine the role of the Food and 
Drug Administration (FDA) in the authorization of investigational use, 
or right-to-try drugs. It's worse than the House version and FDA 
Commissioner Dr. Scott Gottlieb expressed his concerns about this bill 
during a Health Subcommittee hearing in October, 2017.
  This bill once again does not address the true barrier to 
investigational use drugs--the manufacturer. It does not compel 
manufacturers to provide investigational use products to patients or 
physicians. The manufacturer often is justified in not providing 
investigational use drugs to patients due to production and 
manufacturing limitations, or because the manufacturer determines that 
a patient is not an appropriate candidate for their drug. Nothing in 
this bill corrects the barriers of the current system or makes it more 
feasible for manufacturers to

[[Page E752]]

provide investigational use drugs to patients or physicians. It simply 
creates a new system without the any oversight or approval of the FDA 
that plays an important role in authorizing the use of right-to-try-
products.
  Patients trust that the products they receive will not cause more 
harm than good and that they offer some promise of relief and hope. 
This bill creates an alternative pathway for the most vulnerable 
patients in our country to access drugs that have not been approved for 
safety or efficacy outside the FDA's existing protocols.
  In this bill the definition of patient is so broad that it allows for 
a large patient population to access unapproved products, putting a 
greater number of patients at risk of harm of using products that have 
not been tested for efficacy.
  This bill allows any physician to come up with their own informed 
consent form which does not have to meet legal standards. Our sickest 
patients should not have to worry about what they're signing when 
they're desperate to access a treatment they hope can save their lives.
  As a member of the Energy and Commerce Committee, I regret that my 
Committee was not given the opportunity to improve this bill. We did 
not consider this bill under regular order where my concerns and those 
of others could have been addressed and the legislation could have been 
strengthened.
  This legislation should be rejected for the risks it poses to patient 
safety, the false hope it gives patients, and the poor process it 
underwent.

                          ____________________