On July 10, 2015, the U.S. House of Representatives voted with an overwhelming majority in favor of H.R. 6, the 21st Century Cures Act, after a unanimous vote in the House Energy and Commerce Committee in May. The bill is intended to accelerate the pace of medical cures and to provide support for the leading federal healthcare research agencies to discover, develop, and deliver innovative cures to those suffering from incurable diseases. Federal legislators believe that increased support for these research agencies can help spur the current innovation crisis in the pharmaceutical industry, where fewer drugs are being produced per dollar spent on research and development.
The bill includes a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability of health technology, and other issues. The goal is a modernized healthcare system that promotes the adoption of personalized medicine and incentivizes research and innovation by, among other measures, extending exclusivity periods and streamlining approval processes. Importantly, the bill aims to accelerate the rate at which patients will have access to potentially life-saving treatments by directing the U.S. Food and Drug Administration (FDA) to continue its policy of fast-tracking “breakthrough” therapies. The bill also urges the development of new criteria for approving “precision medicine or biological products” based on data submitted for previously approved products that take a similar “underlying approach.” The bill is set to fund an additional $8.75 billion to The National Institutes of Health (NIH) and $550 million to FDA over the next five years. The bill is partially funded by the sale of excess crude oil from the Strategic Petroleum Reserve, a reserve cushion that has only been tapped on a few occasions. Highlights for NIH (Discovery) - Reducing Administrative Burdens for Researchers: The bill directs NIH to recommend how to streamline the grant process for researchers and reduce administrative burdens.
- High-Risk, High-Reward Research: The bill also directs NIH to support research that pursues innovative approaches to major challenges in biomedicine. These methods involve inherent high risk, but have the potential to lead to breakthroughs.
- Precision Medicine
- The bill requires FDA to define the term “precision drug or biological product” and issue guidance to assist sponsors in developing such drugs or biological products.
- The bill also requires that FDA address several topics by guidance, including 1) the evidence needed to support the use of biomarkers, 2) clinical trial design, and 3) the manner and extent to which a benefit-risk assessment may be affected when clinical trials are limited to a specific patient population using biomarkers. The provision also allows for sponsors of precision medicine drugs or biologics designated for a rare disease or condition to rely upon data or information developed by the sponsor of a prior approved drug or indication in order to expedite clinical development.
- Additionally, the bill includes a provision that requires FDA to consider whether a precision medicine drug or biological product is eligible for expedited review and approval, including accelerated approval.
- Streamlining Clinical Trials
- In order to simplify and facilitate compliance by researchers, the Secretary of the Department of Health and Human Services (HHS) is required to harmonize the differences between FDA and HHS Human Subject Regulations within 36 months of the enactment of the Act.
- The bill would remove the limitation on the use of central Institutional Review Boards (IRBs) in medical device trials.
- Exclusivity
- The bill provides for a six-month extension of exclusivity periods for an already approved drug that is approved for a new rare disease or condition in order to provide an incentive for repurposing major drugs to treat rare diseases.
- Medical Device Regulation
- The bill requires FDA to establish a program for priority review of medical devices representing breakthrough technologies.
- It clarifies that valid scientific evidence may include registry data, studies published in peer-review journals, and data collected outside of the United States, as long as certain criteria are met.
- It also establishes a third-party, voluntary quality assessment program that would allow device manufacturers to have their quality systems certified by an FDA-authorized third party. FDA would be able to rely on these certifications for certain purposes in lieu of other required submissions.
- Interoperability Standards: Currently, many electronic health record (EHR) systems do not seamlessly communicate information from system to system. The goal is for EHR systems to communicate with one another via harmonious searching, indexing, and vocabulary translation. The bill requires secure transfer, complete access to information for authorized users, and no information blocking for technologies to be interoperable, and requires HHS to issue guidance by January 2017.
- Telehealth: CMS will present telehealth information to the House and Senate within a year of enacting the bill (including information about those eligible for the Medicare program, CMS’s observations of models, projects, or initiatives, potential procedure codes or diagnoses to be furnished via telehealth, and any barriers which may prevent the expansion of telehealth services).
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