21st Century Cures Act

Floor Speech

Date: Nov. 30, 2016
Location: Washington, DC

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Mr. FITZPATRICK. Mr. Speaker, I do support many of the measures in the 21st Century Cures Act. It will increase choice, access, and quality in health care for all Americans by accelerating the discovery and development of new treatments for patients. The bill ensures our nation's standing as the biomedical innovation capital of the world. It provides funding at the National Institutes for Health to support cancer research and make progress in prevention, screening, treatment, and care.

The 21st Century Cures act will establish a data collection system to track the incidence and prevalence of neurological conditions, which includes MS. This new data system could one day lead to a cure for debilitating diseases, which have aspects we currently do not understand.

I wish this bill contained the ``Right-to-Try,'' which would give my constituents Matt Bellina and Frank Mongiello, both diagnosed with ALS, access to experimental and clinical stage treatments to improve their quality of life.

But this bill does emphasize rare disease research and provides funding which will have a meaningful impact on those afflicted with rare diseases like ALS, Alzheimer's, Parkinson's, Duchenne muscular dystrophy, and mitochondrial disease. As a member of the Mitochondrial Disease Caucus and Rare Disease Caucus, I know this bill will have a big impact for those like Liz Kennerley, who has been a passionate advocate for all those suffering from mitochondrial disease and other rare diseases.

By establishing new review pathways at the FDA, 21st Century Cures will advance new drug therapies for patients with rare, serious, or life-threatening disease. It gives my young constituents living with Duchenne's, like Jake Wesley, a chance to live a longer, better life.

The 21st Century Cures helps individuals and families in mental health crisis. It will serve to increase access to trained professionals, improves communications between doctors and families while ensuring that federal funds are applied to programs that work, supporting organizations in Bucks County like the Lenape Valley Foundation and the National Alliance on Mental Illness. Enhancing crisis response, promoting early intervention, and integrating mental health, substance use and primary care will go a long way in helping the one in five individuals who have a mental health condition so they can live well and thrive.

The bill will grant funds to states to supplement opioid abuse prevention and treatment activities, such as improving prescription drug monitoring programs.

Mr. Speaker, while this bill accelerates the development of life- saving devices and therapies, the 21st Century Cures Act fails to protect patients against dangerous medical devices. For the past two years, I've sought medical device reform in Congress. I sought to raise awareness and advance legislation that protected patients and altered FDA processes and procedures to allow for maximum innovation and maximum safety. Congress ignored the victims affected by faulty, dangerous medical devices and what is more disappointing we were denied a hearing.

I support the measures in the 21st Century Cures Act, but I am concerned that it fails to provide adequate medical device protections for patients. There are two amendments missing to the 21st Century Cures Act: the Medical Device Guardians Act and Ariel Grace's Law.

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