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

Floor Speech

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Ms. SCHAKOWSKY. Mr. Speaker, I thank the gentleman for his generosity and time.

I want to say, Mr. Speaker, that I rise in opposition to H.R. 5247 because it creates a dangerous back door for modern-day snake oil salesmen, a back door around the FDA approval process for people who may or may not be preying on desperate people, and it ignores that there actually is a safe pathway for terminally ill patients to get treatment.

This bill failed to pass last week and it should fail again. It is a harmful policy that both Republican-and Democratic-appointed former FDA Commissioners concluded there is ``no evidence'' that this bill ``would meaningfully improve access for patients, but would just remove the FDA from the approval process and create a dangerous precedent that would erode protections for vulnerable patients,'' the most vulnerable patients. People whose lives are in danger feel that they will try anything, and there are people out there who will prey on that.

This bill denies patients what they really need, which is safe and effective treatments. This bill strips away important safeguards in the name of helping patients, but it does not, and that is why 78 patient groups and doctors, groups like the American Cancer Society, the Cystic Fibrosis Foundation, and the Leukemia & Lymphoma Society, oppose this bill. In total, there are now 110 groups opposing this bill.

Mr. Speaker, I include in the Congressional Record a multipage list of opponents to this bill. Groups Opposed to Right To Try Legislation

ADNP Kids Research Foundation; AIDS Action Baltimore; Alliance for Aging Research; Alliance for Regenerative Medicine; American Academy of Neurology; American Association of Justice; American Cancer Society Cancer Action Network; American Lung Association; American Society of Clinical Oncology; American Syringomyelia and Chiari Alliance Project; Amyloidosis Support Groups; Association for Creatine Deficiencies; Benign Essential Blepharospasm Research Foundation; Biomarin; Bonnie J. Addario Lung Cancer Foundation; Breast Cancer Action; Bridge the Gap--SYNGAP Education and Research Foundation CancerCare; Cancer Prevention and Treatment Fund; Charlotte and Gwenyth Gray Foundation to Cure Batten Disease.

Children's Cause for Cancer Advocacy; Children's Cardiomyopathy Foundation; Congenital Hyperinsulinism International; CurePSP; Cutaneous Lymphoma Foundation; Cystic Fibrosis Foundation; Defeat MSA; The Desmoid Tumor Research Foundation; The Disability Rights Legal Center; Dupl5q Alliance; Dysautonomia Foundation; Equal Access for Rare Disorders; Fight Colorectal Cancer; FORCE: Facing Our Risk of Cancer Empowered; Former FDA Commissioner Margaret Hamburg; Former FDA Commissioner Robert Califf; Friedreich's Ataxia Research Alliance (FARA); Friends of Cancer Research; Georgia State University College of Law; The Global Foundation for Peroxisomal Disorders.

Glutl Deficiency Foundation; The Guthy-Jackson Charitable Foundation; Hemophilia Federation of America; Hematology/ Oncology Pharmacy Association; HLRCC Family Alliance; Hope for Hypothalamic Hamartomas; Hyper IgM Foundation, Inc.; International Fibrodysplasia Ossificans Progressiva (FOP) Association; International Myeloma Foundation; International Pemphigus and Pemphigoid Foundation; International Society for Stem Cell Research; International Waldenstrom's Macroglobulinemia Foundation (IWMF); The Isaac Foundation; Jack McGovern Coats' Disease Foundation; The LAM Foundation; The Leukemia & Lymphoma Society; Lymphoma Research Foundation; Li-Fraumeni Syndrome Association (LFS Association/LFSA); LUNGevity Foundation; Max Cure Foundation.

M-CM Network; Mattie Miracle Cancer Foundation; MitoAction; MLD Foundation; Moebius Syndrome Foundation; The MSA Awareness Shoe; Mucolipidosis Type IV Foundation; The Myelin Project; Myotonic Dystrophy Foundation; National Brain Tumor Society; National Coalition for Cancer Survivorship; National Comprehensive Cancer Network; National Consumers League; National Health Council; National MPS Society; National Niemann-Pick Disease Foundation; National Organization for Rare Disorders (NORD); National Patient Advocate Foundation; National Physicians Alliance; National PKU Alliance.

National PKU News; National Women's Health Network; Neurofibromatosis Northeast; NYU Langone Health; Operation ASHA; Our Bodies Ourselves; PRP Alliance, Inc.; Prevent Cancer Foundation; Public Citizen; Rare and Undiagnosed Network (RUN); Sarcoma Foundation of America; Scleroderma Foundation; The Snyder-Robinson Foundation; Sofia Sees Hope; SSADH Association.

Susan G. Komen; TargetCancer Foundation; Treatment Action Group; The Turner Syndrome Society; TMJA (Temporomandibular Joint Disorders patient organization); United Leukodystrophy Foundation; United Mitochondrial Disease Foundation (UMDF); University of Pennsylvania Perelman School of Medicine; Veterans Health Council; Vietnam Veterans of America; VHL Alliance; Washington Advocates for Patient Safety; Woody Matters; Worldwide Syringomyelia & Chiari Task Force; Yale School of Public Health.

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Ms. SCHAKOWSKY. Mr. Speaker, it opens the door for bad actors to take advantage of terminally ill patients. It is the FDA's job to ensure that drugs are safe and effective, and we can't trust manufacturers to act as this gatekeeper.

There is already a safe process for terminally ill patients to access experimental treatments. Under what is called the expanded access program, 99 percent of applications are approved. The expanded access program plays a vital safety role.

I am very troubled by what can happen to patients in some States who undergo treatment from right-to-try companies. In 19 States, patients using an investigational drug could actually lose their hospice coverage; in 6 States, they could be denied home care coverage. These are the very people who are dependent on hospice and home healthcare, and this bill would cause them to lose that coverage.

This is not a humane, patient-centered bill for people who are facing death; it is just a dangerous pathway for bad actors to exploit those very people.

Mr. Speaker, I urge my colleagues to oppose H.R. 5247, and, again, I thank the gentleman for the opportunity to speak against this piece of legislation.

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