[Congressional Record (Bound Edition), Volume 162 (2016), Part 11]
[Extensions of Remarks]
[Page 15517]
[From the U.S. Government Publishing Office, www.gpo.gov]




                         21ST CENTURY CURES ACT

                                 ______
                                 

                      HON. MICHAEL G. FITZPATRICK

                            of pennsylvania

                    in the house of representatives

                      Wednesday, November 30, 2016

  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.

                          ____________________