East County News Service
July 13, 2015 (San Diego) – The 21st Century Cures Act (H.R. 6) has passed the House of Representatives by a 344 to 77 vote. Among San Diego’s representatives, Democrats Susan Davis, Scott Peters and Juan Vargas voted yes, along with Republican Duncan Hunter. Republican Darell Issa voted no. The measure now advances to the Senate.
The U.S. Food and Drug Adminstration has reported that the bill will offer significant benefits by putting patients first. It allocates nearly $9 billion in mandatory funding for the National Institute of Health (NIH) to encourage biomedical innovation and research into new treatments and cures.
It also creates the NIH and Cures Innovation Fund to direct money over the next five years into accelerating high-risk, high-reward research such as for rare pediatric diseases. The measure also supports efforts to bring more women and minorities into the bioscience field.
Congresswoman Davis, an original cosponsor of the 21st Century Cures Act, states, “Medical research has always been a beacon of hope for patients and their families. That beacon will burn a bit brighter if we can send this bill to the president’s desk, who has expressed his support for the bill. This renews our commitment to medical innovation to help ensure that America remains a leader in this sector and it will spur economic growth.”
A summary of the bill from the Congressional Research Service is below:
Summary: H.R.6 — 114th Congress (2015-2016)All Bill Information (Except Text)
Introduced in House (05/19/2015)
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.