Pallone on “Right to Try": If This Is a Patient Centered Bill—Why Do Patient Organizations Oppose It?
Energy and Commerce Ranking Member Frank Pallone, Jr. (D-NJ) delivered the following remarks on the House floor today during 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 to voice my strong opposition to H.R. 5247, or the federal Right to Try Act of 2018. This legislation, introduced only last week, is an egregious attempt by a libertarian think tank to undermine the “gold standard” drug approval process at the Food and Drug Administration.
The supporters of this bill claim to be helping desperate patients who are looking for hope. If this is such a patient centered bill ---- why does every major patient organization overwhelmingly oppose it?
More than 100 patient organizations, including the National Organization for Rare Disorders, Friends of Cancer Research, and American Cancer Society Cancer Action Network, have written in opposition to this legislation. In a letter to Congressional leadership these 103 patient organizations noted that, “. . . the alternative pathway in the latest version of the legislation is still less safe for our patients than the current expanded access process.”
It’s not only patient organizations that are voicing concern --- four former FDA Commissioners – Drs. Hamburg and Califf who served under the Obama Administration, and Drs. McLellan and von Eschenbach who served under the Bush Administration – also oppose this Republican legislation. That’s two former Republican Commissioners and two former Democratic Commissioners who are opposed to both this House bill and a Senate bill on this same issue. These four commissioners explained their opposition by saying, and I’m quoting, “There is no evidence that either bill would meaningfully improve access for patients, but both would remove the FDA from the process and create a dangerous precedent that would erode protections for vulnerable patients”
This legislation is also not needed.
There is already a successful program in place today at the FDA in which seriously ill patients and their doctors can request access to an experimental treatment from a manufacturer. This application process, which takes as little as 45 minutes for a physician to complete, has been overwhelmingly successful. Last summer, a review by the Government Accountability Office found that FDA approves 99 percent of the requests submitted to the agency.
In fact, of the nearly 17-hundred requests FDA received last year, only nine were not approved. Physicians and patients also receive approval quickly; emergency requests are often granted immediately over the phone and on average receive a response within four days.
While FDA approves 99 percent of the treatments it reviews through the Expanded Access Process, it also adjusts 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. Just imagine the health consequences to patients if these 11 percent of applications had not been adjusted.
This is the very reason that FDA must be involved in this process – if you eliminate FDA review, as this bill does, you are putting patients at risk.
I fear that some members might support this legislation under the false belief that “Right to Try” laws in their states have provided help to patients. This could not be further from the truth.
One example supporters of this legislation like to bring up is Dr. Delpassand of Texas who claims to have treated patients under “right to try.” I would like to enter into the record a letter from Mr. Andrew McFayden of the Isaac Foundation who dispels this myth.
Dr. Delpassand claims to have used “right to try” because FDA would not allow him to do Expanded Access. And this was for a very good reason. FDA placed a “clinical hold” on his study due to the fact that his clinic was not reporting serious adverse events as required and continued to enroll patients despite the clinical hold. The work of Dr. Delpassand’s study was associated with 40 deaths and two hospitalizations.
FDA’s “clinical hold” on Dr. Delpassand’s work is a sign to me that FDA’s Expanded Access pathway was working to prevent bad actors from continuing to expose vulnerable issues to experimental treatments.
As Mr. McFayden noted, “[Right-to-Try] was used because it was the only way for Dr. Delpassand to treat patients in his clinic after it failed inspection. [Right-to-Try] is a loophole designed to allow people who cannot otherwise follow safety rules set forth by the FDA that are meant to protect vulnerable patients. It’s not being used – anywhere – to provide patients with hope or access to life-saving drugs.”
Not only does “Right to Try” expose vulnerable patients to safety risks, it also endangers health and hospice coverage of patients. In 19 state “Right to Try” laws, insurers can deny hospice coverage for patients using a drug obtained through right to try, and four allow states to deny health insurance benefits all together. This puts patients on the hook for thousands of dollars in treatment costs for an experimental drug that might not even work!
Mr. Speaker, H.R. 5247 is dangerous for our patients and is an unprecedented attempt to roll back FDA’s oversight of investigational treatments.
I urge my colleagues to stand with the more than 100 organizations that have come forward to oppose this misguided and harmful legislation.