Energy and Commerce Ranking Member Frank Pallone, Jr. (D-NJ) delivered the following remarks on the House floor during consideration of S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017:
Mr. Speaker, I rise today in strong opposition to S. 204, or the federal “Right to Try" Act. This is dangerous legislation that threatens FDA’s authority over ensuring that medical treatments are safe and effective. This bill needlessly exposes vulnerable patients to the risks of unproven medications.
We heard last night in Rules Committee from my Republican colleagues that we must accept and pass this legislation because the Senate is unable to pass a bill that passed the House earlier this year. That House bill was bad enough, but this Senate bill is much worse.
I cannot fathom why my Republican colleagues are surrendering to the Senate and agreeing to pass a more dangerous version of “Right to Try" legislation.
This Senate bill, like the House bill, establishes an alternative pathway for experimental treatments that eliminates any review from the Food and Drug Administration and scientific and medical experts of an Independent Review Board. This will provide fly-by-night physicians and clinics the opportunity to peddle false hope and ineffective drugs to desperate patients.
At a hearing before our Committee, FDA Commissioner Scott Gottlieb cautioned that S. 204 risks, “exposing people to unwanted side effects from experimental therapies." Supporters of this bill would have you believe this legislation is targeted to those with terminal illnesses, but that is simply not the case. S. 204 would in fact apply to much broader range of patients diagnosed with a “life-threatening disease or condition."
The term “life-threatening disease or condition" could include chronic, and often manageable, diseases, such as diabetes or chronic heart failure. If all patients with diabetes, and other chronic but manageable illnesses were eligible, it could greatly expand the scope of the legislation well beyond the scope of most state laws and FDA’s expanded access program. This exposes an even greater number of patients to risk, and undermines our clinical trial program by diverting patients from trials that could support full approval to the alternative pathway.
Commissioner Gottlieb also cautioned Congress that this legislation risks, “undermining a regulatory process that has been carefully crafted over many years to strike a very careful balance." The Commissioner noted that S. 204 would not subject all participants in the alternative pathway to critical regulatory requirements such as labeling products as investigational, charging limitations, and restrictions on promotion and commercialization of such treatments.
S. 204 also could impede FDA from taking action against manufacturers and others that violate other provisions of the Federal Food, Drug, and Cosmetic Act. Under this bill, if a bad actor is not in compliance with good manufacturing practices, or does not protect against intentional adulteration, or allows dishonest or misleading labeling, the FDA will not be able to take any action.
More importantly, this federal “Right to Try" bill simply is not necessary.
FDA’s Expanded Access program has an approval rate of nearly 100 percent. To be clear, FDA’s high approval rate is not just a rubber stamp for these applications. Of the applications FDA receives and approves, it also adjusts applications for 11 percent of patients to improve patient safety protections. This could include modifying the dosing, strengthening informed consent, or improving safety monitoring. We must protect patients from bad actors, or from dangerous treatments that might make their lives worse. Without this critical review there will not be any oversight to ensure patients are not being taken advantage of or put in harm’s way.
The main reason this bill is being pushed is to chip away at FDA’s authority to ensure the safety and effectiveness of our drugs. FDA oversight of access to experimental treatments exists for a reason - it protects patients from potential snake oil salesmen or from experimental treatments that might do more harm than good. By removing FDA oversight, you are counting on physicians and manufacturers to serve as the gate keeper and protector of patients. I simply don’t buy that that’s going to work.
Supporters of this bill want to blindly believe that there are no bad actors out there. Imagine someone like Martin Shkreli promising a dying patient a cure that could save their life. Under this bill, FDA would play no role in determining whether or not Shkreli could provide that drug to that dying patient. If S. 204 is signed into law, patients will be taken advantage of and will be harmed.
Bad actors exist and this Republican bill gives them the opportunity to prey on desperate people who are understandably looking for any treatment that might help save their life.
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? Where is the call from patients for this legislation?
More than 100 patient organizations, including the National Organization for Rare Disorders, Friends of Cancer Research, and American Cancer Society Cancer Action Network, sent a letter to Congress just yesterday opposing this legislation. In the letter they stated, “the Senate version of the legislation is less safe than the pathway proposed in the House version and is dangerous compared to the current expanded access process."
Four former FDA Commissioners from both parties also oppose this Republican legislation noting that, “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."
Mr. Speaker, S. 204, a key agenda item for the President and Vice President, 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.
Thank you, I reserve the balance of my time.
