HR-6 : Still Just a Bill

21st Century Cures Act

This bill amends the Public Health Service Act to reauthorize the National Institutes of Health (NIH) through FY2018. The NIH Innovation Fund is established to fund a strategic plan, early stage investigators, and high-risk, high-reward research.

The NIH may require scientific data to be shared if the research is fully funded by the NIH.

The NIH and the Food and Drug Administration (FDA) must implement a system that allows further research on clinical trial data.

The Centers for Disease Control and Prevention must expand surveillance of neurological diseases.

The Council for 21st Century Cures is established to accelerate the discovery, development, and delivery of innovative cures, treatments, and preventive measures.

The Department of Health and Human Services must monitor the use of antibacterial and antifungal drugs and resistance to these drugs.

Requirements are established for interoperability and certification of health information technology. Practices that discourage the exchange of electronic health information are prohibited.

This bill amends the Federal Food, Drug, and Cosmetic Act to revise the drug approval process, including by: (1) allowing patient experience data to be considered in the risk-benefit assessment of a new drug, (2) requiring the FDA to qualify drug development tools, (3) allowing the FDA to rely upon data previously submitted for a different purpose to expedite the development of certain drugs, and (4) establishing a streamlined data review program for approval of a drug for an additional indication.

Manufacturers and distributors of investigational drugs for serious conditions must publish their policies on compassionate use requests.

The marketing exclusivity period is extended by six months for a drug approved for a new indication that is a rare disease or condition.

The priority review voucher program for rare pediatric diseases is revised and extended.

The FDA must: (1) establish a program for priority review of breakthrough medical devices, (2) identify types of devices that do not require a report preceding introduction, and (3) rely on a third-party to determine the safety and effectiveness of changes to medical devices.

Regarding medical devices, this bill defines “valid scientific evidence” and makes changes to classification panels and the humanitarian device exemption.

“Health software” is defined and, with certain exceptions, exempted from FDA regulations.

This bill amends title XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services (CMS) to: (1) increase certain payments for new antimicrobial drugs, (2) establish a payment methodology for certain medical devices, and (3) publish online estimated payments for certain outpatient items and services.

A pharmaceutical and technology ombudsman within the CMS must respond to complaints from manufacturers of medical products.

Medicare prescription drug plan sponsors may limit the access of certain beneficiaries to frequently abused drugs.

This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.