On Wednesday, November 29th, the U.S. House of Representatives voted to pass H.R.6, the 21st Century Cures Act, which will likely be voted on by members of the U.S. Senate in early December. The act’s purpose is to accelerate the discovery, development and delivery of new medicines. Media reports indicate that the bill would set in motion a $6.3 billion initiative in an effort to not only fund research in development in many medical fields but also increase consumer access to various treatments. By some measures, this bill is reportedly the largest reform of the U.S. health sector since 2010’s Affordable Care Act.
If enacted, the 21st Century Cures Act would establish a U.S. Treasury fund called the NIH and Cures Innovation Fund. That fund would receive $1.86 billion per year over four fiscal years up to 2020. Each year, $1.75 billion of those funds would be reserved for biomedical research of the National Institutes of Health (NIH), including basic, translational and clinical research. At least $500 million of these NIH funds would be used for an Accelerating Advancement Program to partner with national research institutes and national centers to accomplish biomedical research objectives. Of the remaining $1.25 billion or less, at least 35 percent will be allocated to early stage investigators which have earned at most one NIH competitive grant; at least 20 percent allocated for “high-risk, high-reward research”; and at most 10 percent reserved for intramural research. The other $110 million left in the yearly budget will be allocated to a cures development program and will fund drug manufacturing studies, health software and obtaining data on disease history.
Most of the bill is spread out among three titles, the first of them being discovery. This section instructs the NIH to establish an Innovation Prizes Program to fund areas of biomedical research “that could realize significant enhancements or improve health outcomes.” It also enables the NIH to offer support in later phases of clinical trials, calls for more collaboration with the U.S. Food and Drug Administration (FDA) to “implement a system that allows further research on clinical trial data” and establishes a nonprofit organization, Council for 21st Century Cures, which will focus on efforts to accelerate medicine discovery, development and delivery.
Title II of the 21st Century Cures Act focuses on the development aspects of the proposed bill and heaps no small amount of responsibility on the FDA. It amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require the FDA to “establish processes under which patient experience data may be considered in the risk-benefit assessment of a new drug.” The FDA must also identify “precision” drugs which can treat serious or rare diseases and expedite their development, establish a program for priority review of breakthrough medical devices and train FDA employees on the “least burdensome appropriate means” concept in their review of medical devices. At the same time that the proposed bill would take away FDA authority in certain regards, such as requiring the agency to rely on third party certification of the safety and effectiveness of medical devices as meeting FDA criteria, it also authorizes additional hiring authority for the FDA for scientific, technical and professional positions within agency centers.
Title III deals with the delivery of innovative treatments and is perhaps the most tech-heavy section of the 21st Century Cures Act. This section would establish requirements for the interoperability and certification of health information technology, requires Medicare and Medicaid authorities to provide telehealth information to Congress and directs those same authorities to pay home health agencies for certain disposable medical devices made for individuals receiving home health services through Medicare. It also gives Medicare prescription drug plan sponsors the ability to limit drug access to certain beneficiaries for frequently abused drugs and appoints an ombudsman to respond to manufacturer complaints regarding Medicare coverage of their products.
Finally, Title IV of the act is directed towards Medicare and Medicaid reforms. It limits aggregate Medicaid payments to states for durable medical equipment and excludes certain generic drugs from the calculation of average manufacturer price when determining Medicaid rebates. This section also reduces Medicare payments for x-ray imaging technologies which use film or an imaging plate instead of a digital sensor and revises Medicare payments for infusion drugs and biologicals furnished through durable medical equipment. The U.S. Department of Health and Human Services (HHS) would also be directed to increase its support of Lyme disease and tick-borne diseases through strategic research. Interestingly, this section of the proposed bill also includes a rider provision which would direct the U.S. Department of Energy (DOE) to sell 80 million gallons of crude oil from the Strategic Petroleum Reserve through fiscal year 2025; it’s possible that this provision was added in order to fund new research required by this act.
The 21st Century Cures Act has broad bipartisan support having been passed in the U.S. House by an overwhelming 344-77 roll call vote. It also has the backing of the White House; a statement release from the White House’s Office of the Press Secretary on November 30th calls the 21st Century Cures Act “critically important legislation” which increases funding to combat the American heroin epidemic, supports the “Cancer Moonshot” led by Vice President Joe Biden and takes meaningful steps towards improving mental health and Alzheimer’s disease outcomes.
There are those, however, who are quite critical of certain aspects of the 21st Century Cures Act, especially in regards to how the legislation would affect FDA regulatory activities. Some have pointed out that the changes to the FDA drug and device approval process favor speed in approval over accuracy and patient safety concerns. The worry is that the spirit of wanting to speed drug development to find cures to rare and serious diseases has led to the cutting of compliance regulations which could risk patient safety. Others have pointed to the fact that decentralization of FDA authority on what constitutes a “safe and effective” drug could lead to inconsistent application of those rules. The bill also has significant detractors in the U.S. Senate, with both Sens. Bernie Sanders (I,D-VT) and Elizabeth Warren (D-MA) have both openly come out as being against this legislation, with Sanders’ disapproval coming from a released statement while Warren voiced her concerns on the Senate floor in late November.