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 rise in opposition to H.R. 5247 because it actually creates a dangerous back door around the Food and Drug Administration approval process and it ignores that there is a safe pathway for terminally ill patients to get the treatment that they need.

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. It is not patient friendly. That is why 78 patients and doctor groups are all opposed to this legislation, like the American Cancer Society, the National Brain Tumor Society, the Leukemia and Lymphoma Society, and the Vietnam Veterans of America.

Mr. Speaker, I include in the Record this 5-page list of the opposing groups. 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. We can't trust manufacturers to act as a gatekeeper.

The important thing to know is there is already a safe process for terminally ill patients to access experimental treatments. Under the Expanded Access Program, 99 percent of applications are approved, and they are done in a speedy way.

This process is not merely a rubber stamp. The FDA plays a vital role in ensuring these experimental treatments are safe.

Even more important, in 19 States that have passed right-to-try laws, patients using an investigational drug can lose their hospice care; and in 6 States, they can be denied home healthcare. These are the very people who depend on hospice and home care, and they could lose those services.

This is not a humane, patient-centered bill for people who are facing death. It is just a dangerous pathway for bad actors to exist.

Let's go with the positive ability right now that we have. Ninety- nine percent of those desperate people looking for hope will get it from the Food and Drug Administration. So I urge my colleagues to oppose H.R. 5247.

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