Bills
| 3.23.22

21st Century Cures: Funding Research, Development and Delivery of New Medical Treatments (H.R. 34)

Do you support or oppose this bill?

What is H.R. 34?

(Updated May 13, 2019)

This bill was enacted on December 13, 2016

Update: November 28, 2016: This bill was co-opted through the Senate's amendment process to serve as the legislative vehicle for the 21st Century Cures Act. Originally the bill provided funding for a tsunami warning system and related preparedness and education efforts.


With a wide reach, the 21st Century Cures Act aims to enhance medical innovations and reforms the ways that the Food and Drug Administration (FDA) approves new drugs and medical devices. The bill is divided into three major titles; discovery, development, and delivery. Here are the highlights:


Discovery

The National Institutes of Health (NIH) would be reauthorized, and funded with over $34.8 billion for fiscal year 2018, $35.5 billion for fiscal year 2019, and $36.4 billion for fiscal year 2020. This bill establishes an Innovation Fund within the NIH for medical research. This fund would receive an additional $2 billion in appropriations beyond what is given to the NIH as a whole for each fiscal year between 2018 and 2020.

The NIH would also develop a five-year strategic plan for biomedical research. Individual research centers within the NIH would use that plan for their research activities. Rare and pediatric diseases would remain a strategic priority for NIH research.

To incentivize young scientists and researchers to join the NIH, the federal government would pay $50,000 per year of student loans taken out by health professionals who are conducting qualified research.

A clinical trial registry database on eligibility for clinical trials would be established by the NIH. It would be accessible to the public in hopes of facilitating collaborative research.

This bill would also establish a Council for 21st Century Cures, which would be organized as a nonprofit unaffiliated with the U.S. government. It would focus on accelerating the development of cures, treatments, and preventive measures for patients.


Development

The Food and Drug Administration (FDA) would develop and utilize patient experience data when assessing the risks and benefits of drug development. It would also create drug development tools to help applicants get approval, licensing, or deeper investigation of medical products when creating new treatments.

Drug developers could apply for an accelerated approval development plan after they've applied for the drug’s investigation. That said, the Secretary  require the plan to be modified or terminated if the drug is shown to be unsafe or not effective enough.

The FDA would be mandated to create an Expanded Access Policy for investigational drugs to give patients who could benefit from the drug earlier access to it. Access wouldn’t be guaranteed, but information about the policy would be publicly available. A finalized version of this policy would be settled within 12 months of this legislation’s enactment.

Patients facing life-threatening or serious infections could receive certain antibiotic drugs, as the FDA would be allowed to approve antibiotics and antifungal drugs for use in small populations of patients where there is an unmet medical need. These drugs would be labeled with the phrase ‘Limited Population’ featured prominently on the packaging.

The FDA would also be responsible for monitoring resistance to antibiotic and antifungal drugs. In order to encourage the development of new drugs of these categories, the FDA would offer additional payments through Medicare for types of these drugs that make it to the market for the first four years that the drugs are in use. There would be a cap on these payments so that they may not comprise more than 0.06807 percent of the total payments for that year.

An Advisory Committee on Immunization Practices would establish a process for reviewing and approving new vaccines. That process would be reviewed and approved by the Centers for Disease Control and Prevention (CDC). The CDC would meet with vaccine developers to help them with licensing, and context, like the demographic data of populations affected by relevant diseases.

So-called ‘breakthrough devices’ that can provide treatments which have no approved alternatives could be given priority during the review and approval process. New medical devices would also have their quality assessments conducted by third parties. Within one year, the Secretary of the FDA would make recommendations about continuing this program, and evaluate its performance.

The FDA would allow adaptive trial designs for new drugs that utilize Bayesian statistical methods in research. Evidence from clinical experience could also be applied to new drug research to satisfy post-approval study requirements.


Delivery

The interoperability of health information technology would be based on the secure transfer of a patient’s data, and complete access to that health data without information being blocked.

Within one year, the Centers for Medicare and Medicaid would provide a report on what types of illnesses could be diagnosed through telehealth among Medicare beneficiaries.

To promote transparency for treatment prices, estimated payment amounts for outpatient procedures would be listed on a publicly searchable database so that beneficiaries can be aware of their liability.

Programs to protect patients while preventing and reducing drug abuse would be established, including a program to protect at-risk beneficiaries.

Argument in favor

This legislation is a robust and collaborative overhaul of the way that new treatments are developed, tested, approved and delivered — it will help bring our health care system into the 21st Century.

Argument opposed

While its objectives are noble, this bill is so unwieldy, it will be difficult for industries to adapt to the reforms. It also poses threats to patient safety by cutting the time that the FDA has to approve new medical treatments.

Impact

People in the U.S. who need health care, health care providers and the facilities they work for, pharmaceutical companies, the FDA, the CDC, CMS, the Secretary of Health and Human Services.

Cost of H.R. 34

The CBO estimates that this bill would cost about $5.8 billion over the 2017-2026 period.

Additional Info

Of Note: There are more than 2 million U.S. jobs in the medical device industry, while the biopharmaceutical industry as a whole supports over 4 million U.S. jobs.

Rare diseases account for somewhere between 6,000 and 8,000 of the 10,000 known diseases, and there are only treatments for only 500 of those rare diseases.

Estimates from 2014 found that it now costs about $2.6 billion to bring a new drug to market after going through the process of developing, testing, and obtaining approval for the new drug.


In-Depth: The Chairman of the House Energy and Commerce Committee, Rep. Fred Upton (R-MI), called this bill: 

“A big bipartisan step forward on our path to cures. We have all said too many early goodbyes to people we love and treasure. Every single person has a common goal: we want more time with those we love. In this, the greatest country in the world, Americans deserve a system second to none. We can and must do better. The time for 21st Century Cures is now.”

Unsurprisingly, some of this bill's biggest critics are top officials at the FDA, who are concerned that these reforms pose risks to patient safety by streamlining the approval process for new treatments. One example they foresee is: 

"By potentially permitting shorter clinical trials and letting drug companies use alternative measures of health as evidence of a drug’s effectiveness and safety."

This legislation was passed unanimously by the House Energy and Commerce Committee on a 51 to 0 vote, after the Committee spent more than one year receiving input from patients, caregivers, innovators, researchers, and regulators.


Media:

Summary by Eric Revell
(Photo Credit: U.S. Air Force / Public Domain)