Because No One is Immune to the Law
July 26, 2021 - United States, FDA, Healthcare

Cures 2.0: Will It Be Better Than the Original?

Is 2021 the Value-Based and Shared Savings Revolution?

It’s summer blockbuster season and that means sequels abound.  Now it seems that the U.S. Congress wants in on the action.  Just five years after Congress passed the 21st Century Cures Act, a bipartisan group of representatives is looking to enact follow-up legislation—“Cures 2.0.”  Last month, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) released draft legislation that proposed sweeping policy changes, many of them inspired by the COVID-19 pandemic.  If passed into law, the 127-page legislation would affect medical research, health insurance, and FDA regulatory policies; it would even establish a new agency.

This life sciences blog hopes to explain the discussion draft for Cures 2.0.  It begins with a quick recap of the first Cures Act, then explains the content of the proposed legislation.  Finally, we forecast what to expect going forward.

21st Century Cures Act

Congress enacted the 21st Century Cures Act to speed up the development of medical products and encourage more innovation, all with the end goal of curing hard-to-treat diseases.  The Act authorized $6.3 billion in funding, with approximately three-quarters of that money allotted to the National Institutes of Health (NIH).  The legislation funded new medical research programs at NIH, including the Cancer Moonshot, the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative, and the Precision Medicine Initiative.  The Cures Act also addressed health information technology interoperability, including significant provisions prohibiting information blocking.

With respect to the Food & Drug Administration (FDA), the Cures Act modernized the agency’s hiring authorities.  It directed FDA to create intercenter institutes, such as the Oncology Center for Excellence.  It updated FDA’s regulation of combination products (which combine drugs, devices, and/or biological products).  It sought to streamline the drug approval process by facilitating the use of surrogate-markers, such as real-world evidence.  It created expedited product development programs, including Regenerative Medicine Advanced Therapy (RMAT) and the Breakthrough Devices program.  And it amended the Food, Drug, and Cosmetic Act to exclude certain software functions from the definition for medical devices.[1]

President Obama signed the Cures Act into law on December 13, 2016, just weeks before leaving office.  The law enjoyed overwhelming support from industry and other stakeholders.  Notably, then-Vice President Biden was a major proponent of the legislation.

Cures 2.0 Draft Legislation

Cures 2.0 features five substantive titles.  This blog post details some of the most significant provisions.

Title I covers public health, with an emphasis on learning from the COVID-19 pandemic.  It would establish a national survey of patients with long COVID, create a learning collaborative, and assess sources of coverage.  It would direct the Department of Health and Human Services (HHS) to develop and implement a national strategy to prevent and respond to pandemics.  The strategy would be “based on lessons learned, and best practices developed, as a result of the COVID-19 pandemic”; it would focus on testing, expanding domestic drug manufacturing, and developing vaccines, therapeutics, and other medical supplies.  The Act would appropriate $25 million per year in grants to educate the public about vaccines.  And it would adopt the PASTEUR Act, which would create an innovative subscription model to pay for the development of novel antibiotics to address antimicrobial resistance.

Title II covers patients and caregivers and directs the Centers for Medicare & Medicaid Services (CMS) to consider ways to improve patient health literacy, among other goals.  Title II would also work to increase diversity in clinical trials through, for example, public awareness campaigns and more user-friendly registration.  It would also require reporting on patient experience data in a clinical trial and require FDA to consider that data.

Title III covers provisions relating to FDA.  It would direct FDA to report to Congress on the agency’s coordination of the regulation of digital health products, which include wearables, artificial intelligence, cloud services, and software.  It would create grants for innovative clinical trial design.  Title III also focuses on accelerated approval programs for drugs.  It would direct FDA to issue guidances on the chemistry, manufacturing, and controls information required for expedited approval and the use of real world evidence to evaluate the safety and effectiveness of drugs after approval or licensure under a breakthrough, fast-track, or accelerated pathway.  It would allow for earlier designation as an RMAT or breakthrough therapy before an Investigational New Drug (IND) and would allow for more sources of data to support post-approval study requirements.  Title III also addresses improving collaboration between FDA and CMS regarding designation of a product as a breakthrough therapy, a fast- track product, or a product eligible for accelerated approval. 

Title IV covers CMS separately, with a particular emphasis on telehealth coverage.  It would extend telehealth flexibilities offered during the pandemic to permanently remove geographic and originating site restrictions and it would encourage the use of telehealth  for Medicaid and the Children’s Health Insurance Program (CHIP).  It would also address patient access to breakthrough devices by codifying the current Medicare Coverage of Innovative Technology pathway.  It would provide federal support for the use of genetic and genomic testing for pediatric patients with rare diseases and would create a pilot grant program within CMS to test approaches to delivering personalized medicine consultations.

Last, but certainly not least, Title V of Cures 2.0 would establish a new agency called the Advanced Research Projects Agency for Health (ARPA-H) within NIH.  Modeled after the Defense Advanced Research Projects Agency (DARPA), ARPA-H would promote bold breakthroughs in medicine.  Examples of potential ARPA-H projects include mRNA vaccines for most cancers, wearable monitoring devices for blood pressure/blood sugar, brain imaging technology for tracking responses to Alzheimer’s therapies, vaccine patches or oral sprays for mass vaccination campaigns, and programs aimed at healthcare access and equity, according to an article that the White House published in Science Magazine to coincide with the draft legislation.  Cures 2.0 would provide $6.5 billion to ARPA-H in FY2022.

What to Expect

Cures 2.0 already enjoys bipartisan support and is a legislative priority for President Biden.  Rep. DeGette has publicly proclaimed that she hopes to pass the bill later this year.  For now, Congress and the White House are focused on gathering feedback from industry, academia, and other groups.  This process is already underway, with many notable organizations praising the discussion draft and providing detailed comments.  We encourage life sciences companies that are interested in providing feedback to submit comments to Congress as soon as possible.

Even enactment of Cures 2.0 would be far from the final word.  The discussion draft delegates significant authority to regulatory agencies and requires those agencies to issue regulations and guidance on several topics.  Such regulatory actions would provide further opportunities for input from life sciences companies.  All in all, the next several years will be an exciting time for drug, medical device, and life sciences innovations, thanks in large part to Cures 2.0.  This is one sequel that promises to be as exciting as the original.

[1] The FDA promulgated a new rule on this topic earlier this year.