Dear Mr. Austin:
Thank you for taking the time to contact me about H.R. 34, the 21st Century Cures Act. I appreciate hearing from you about this issue.
To develop the original version of the 21st Century Cures Act, the Committee on Energy & Commerce in the House of Representatives held numerous hearings and received feedback from key stakeholders on how Congress can help to accelerate the development of new treatments and cures in the United States. Ultimately, the Energy & Commerce Committee approved, and the House passed, a bill that addressed the full drug and device development process, from basic scientific research to the delivery of new treatments to patients. Starting in early 2015, the Senate Committee on Health, Education, Labor, and Pensions (HELP), of which I am a member, began to develop its own proposal similar to the 21st Century Cures Act. The Committee held several hearings and approved a number of bills related to this innovation agenda. Together, this package of bills was the Senate’s version of the 21st Century Cures Act.
The final version of the 21st Century Cures Act, H.R. 34, reconciles the differences between the House and Senate proposals. As a member of the HELP Committee, I actively participated in the development of the Senate proposal, and was pleased that H.R. 34 contained several of my priorities. As such, I voted for H.R. 34 when it passed the Senate in a bi-partisan, 94 to 5 vote. This legislation was signed into law by the President on December 13, 2016.
As a bipartisan compromise between the House and the Senate, I recognize that this legislation is not perfect. However, as a whole I believe that it is an important step in ensuring that our Nation provides adequate support for groundbreaking medical innovation and research. H.R. 34 contains provisions that will improve the drug and device approval process at the Food and Drug Administration (FDA). It will also boost funding for the National Institutes of Health, and contains important, specific funding provisions for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, the Precision Medicine Initiative and the Cancer Moonshot. Finally, H.R. 34 also contains language based on S. 2680, a bi-partisan mental health reform bill; S. 1503, which will help the federal government properly coordinate efforts to combat Lyme disease; and funding to address our Nation’s heroin and prescription opioid abuse epidemic. All of these priorities are extremely important, both for Pennsylvania and the entire country.
Additionally, I am happy to report that the final version of 21st Century Cures contained language based on several proposals that I introduced or actively helped to develop. Those proposals include:
• S. 1878, the Advancing Hope Act, a bill I introduced that would make the pediatric priority review voucher program permanent. These vouchers entitle companies to receive a “priority” six-month review of another new drug application if they develop a treatment for a rare pediatric disease, such as a pediatric cancer. A voucher can be used by the company that receives it, or sold to another company. Although the final version of H.R. 34 did not make this program permanent, I was able to secure the inclusion of language to extend it through September 30, 2020.
• S. 1767, the Combination Product Regulatory Fairness Act of 2015, a bill that I developed with Senator Johnny Isakson of Georgia. This would improve the FDA review process for medical products that combine aspects of both drugs and medical devices.
• S. 2055, the Medical Countermeasures Innovation Act of 2015, which I developed with Senator Richard Burr of North Carolina. This would include a number of targeted improvements to the Pandemic and All Hazards Preparedness Act, building upon my work with Senator Burr on that program’s reauthorization in 2013.
Although passage of the 21st Century Cures Act is an important step, I recognize that work remains to be done. Please be assured that I will continue to support proposals that improve and enhance medical innovation efforts, and ensure that sustained funding for medical research remains one of my top priorities in the Senate.
Again, thank you for sharing your thoughts with me. Please do not hesitate to contact me in the future about this or any other matter of importance to you.
For more information on this or other issues, I encourage you to visit my website, http://casey.senate.gov. I hope you will find this online office a comprehensive resource to stay up-to-date on my work in Washington, request assistance from my office or share with me your thoughts on the issues that matter most to you and to Pennsylvania.
Sincerely,
Bob Casey
United States Senator
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