The 21st Century Cures Act (“the Act”) is intended to address a significant number of current challenges within the industry including reduction of barriers to research collaboration, incorporation of the patient perspective into the drug development and regulatory review process, earlier identification of diseases through personalized medicine, modernization of clinical trials, and the elimination of regulatory uncertainty for the development of new medical applications. It also includes provisions to incentivize the development of drugs for rare diseases, invest in science and the next generation of investigators, and support the biomedical ecosystem to accelerate discovery of new cures.
The Act proposed changes in regulatory oversight that will affect many aspects of the Product Lifecycle within the Life Sciences industry including:
The House Energy and Commerce Subcommittee advanced the bill on May 21, 2015, on the strength of a 51 – 0 vote to the House of Representatives. The House passed the resolution on July 10, 2015 with a bipartisan vote of 344 – 77. The bill then stalled for over a year in the Senate over funding for the Act. On November 25, 2016, a compromise on the funding was reached and on November 30, 2016 the House passed the Act by an even wider margin, 392 – 26, than the July 10, 2015 vote. The Senate passed the bill 94 – 5 on December 7, 2016 and on December 13, 2016 President Obama signed the Act into law.
The accelerated use of technologies such as biomarkers, human genome mapping, mobile medical applications, cloud computing, and social media are not only having a profound effect on consumers but also on biopharmaceutical and medical device organizations and federal regulators as well. The Act is divided into the twenty-five titles. A majority of the titles (Titles V – XXV) affect Medicare, Medicaid, Mental Health Reform and other support services and are not the subject of this blog. Titles I – IV: Innovation, Discovery, Development, and Delivery have numerous provisions (sections) primarily affecting the National Institutes of Health (NIH) and the Food & Drug Administration (FDA). For example, the bill, through Title I, Innovation, establishes funding for the NIH of $4.8 billion over ten years for the Precision Medicine Initiative, the Brain Research Through Advancing Innovative Neurotechnologies Initiative, cancer research, and regenerative medicine using adult stem cells. It also provides funding for FDA of $500 million over ten years to be used to expedite access to drugs and medical devices for patients, while maintaining current safety and effectiveness standards.
Title II, Discovery, Subtitle F Sections 2061, 2062, Facilitating Collaborative Research, promotes a National Neurological Conditions Surveillance System and calls for improved methods for prevention, diagnosis, and treatment of tick-borne diseases. Life sciences companies focused on neurological research as well as those involved in Lyme disease treatments may benefit. Similarly, promoting pediatric research through NIH (Subtitle G, Sections 2071, 2072) establishes national and global pediatric research networks to pool resources related to pediatric rare diseases. Such a network may be helpful to organizations conducting research in the pediatric market.
The Discovery title also encourages the advancement of the Precision Medicine Initiative (PMI). PMI is a research effort to prevent and treat disease based on lifestyle, environment and genetics. Subtitle B, Section 2011 calls for the application of genomic technologies to better understand diseases. Industries developing such technologies may be able to leverage this initiative.
Title IV, Delivery, Sections 4003, Interoperability, focuses on the interoperability of health information technology, and Electronic Health Information (Section 4006) that empowers patients to access electronic health information. These provisions involve a very large ecosystem of devices, information systems, and networks, including new technologies such as cloud computing. Organizations should be focused on the impact and potential opportunities concerning data analytics, data networking, and data security.
Many of the provisions that affect life sciences companies are delineated in Development (Title III). For example patient focused drug development, advancing new drug therapies, and modern trial design and evidence development may impact life science companies’ research by focusing on the voice of the patient, promoting innovative therapies, working on rare disease treatments, and streamlining clinical trials.
The Development title also includes several medical device innovations such as expediting device reviews, recognizing consensus standards, improving the device classification process, and clarifying the definition of a medical device with respect to software. These sections may impact life science companies exploring devices with breakthrough technology, developing humanitarian use devices, adopting recognized standards, assessing risk classification of devices, and creating medical device software.
Life sciences companies should assess how these changes will affect their business now that the Act has become law: