From the Office of U.S. Senator Johnny Isakson:
WASHINGTON – U.S. Senators Johnny Isakson, R-Ga., and Bob Casey, D-Pa., applauded committee passage of two bipartisan bills they introduced to improve healthcare quality and accessibility for Americans.
The Over-the-Counter Drug Safety, Innovation, and Reform Act, S.2315, was approved 22-1 by the Senate Committee on Health, Education, Labor and Pensions. This legislation, which was introduced by Isakson and Casey in January, provides a long-awaited overhaul of the way over-the-counter medications are regulated and brought to market. Reforms included in the bill aim to protect public health and encourage the development of new products to better meet the needs of patients.
The committee also passed the Children’s Hospital Graduate Medical Education Support Reauthorization Act unanimously by voice vote today. Casey and Isakson introduced this reauthorization in March to ensure that children’s hospitals have the support they need to provide adequate medical education and training for pediatricians and other residents. The bill extends a successful grant program for hospitals including Children’s Healthcare of Atlanta, the Children’s Hospital of Philadelphia (CHOP), Children’s Hospital of Pittsburgh of University of Pennsylvania Medical Center, and St. Christopher’s in Pennsylvania, so that their residency programs are funded similar to what other teaching hospitals receive through the Medicare program.
“The Over-the-Counter Drug Safety, Innovation, and Reform Act passed by committee today to overhaul and modernize our woefully outdated over-the-counter drug approval process is a long time coming,” said Isakson. “I’m thrilled that we’re making progress in Congress to ensure the health products in Americans’ medicine cabinets and on supermarket shelves are effective and accessible for patients and that innovations can be made well into the future. I’m also pleased the committee passed legislation to provide continued investment through the Children’s Hospital Graduate Medical Education program and help ensure our pediatric workforce and healthcare facilities are receiving the support necessary to deliver quality care. I urge the Senate to act quickly on each of these pieces of legislation that will help improve the lives of so many Americans.”
“Reauthorization of the Children’s Hospital Graduate Medical Education program will ensure that we can help grow the specialized workforce needed to adequately care for our nation’s children,” said Casey. “The Over-the-Counter Drug Safety, Innovation, and Reform Act represents a common-sense, bipartisan modernization of the regulation of over-the-counter drugs to provide confidence to American consumers that these drugs have appropriate oversight from the Food and Drug Administration. I am pleased to see committee passage of this legislation and look forward to working with my colleagues in the Senate to ensure these important measures becomes law.”
The current system used by the Food and Drug Administration (FDA) to regulate these medications, called the “over-the-counter monograph system,” was implemented in 1972. While modern medicine is constantly improving and adapting as research offers new information, the regulatory system is outdated, putting consumer health at risk and hindering innovation that could benefit all Americans.
The Over-the-Counter Drug Safety, Innovation, and Reform Act seeks to streamline and modernize the FDA’s regulatory system to better serve the American public.
Isakson and Casey’s Over-the-Counter Drug Safety, Innovation, and Reform Act, which was introduced on Jan. 17, 2017, also aims to speed up the current years-long approval process for these medications.
The pharmaceutical industry would help cover much of the cost of the updated regulatory system through “user fees” to support review, new information technology (IT) infrastructure and new full-time employees for the FDA.
Specifically, the legislation would:
- Change the cumbersome monograph rulemaking process to an administrative order process (the same legal authority used for other medical product approvals).
- Allow the secretary of the U.S. Department of Health and Human Services to take rapid action to protect public health in the event of safety issues.
- Establish processes for manufacturers to request administrative orders, or for the secretary to initiate administrative orders at the recommendation of the FDA or in response to citizens’ petitions.
- Establish a process by which drug developers can request meetings with the FDA, similar to existing processes for prescription drug development.
- Create a new incentive to bring innovative over-the-counter products to consumers by providing a two-year period of product differentiation to reward innovation.
- Conform to sunscreen regulations to make sure Americans have access to the latest protective technology.
- Require an annual update to Congress on the FDA’s evaluation of the cold and cough monograph with respect to children under the age of six.
- Authorize the FDA to collect user fees so that the agency has the necessary resources to evaluate and monitor the over-the-counter market.
The full text of the legislation can be found here.
More on the Children’s Hospital Graduate Medical Education (CHGME) Program Reauthorization:
For more than a decade, the Children’s Hospital Graduate Medical Education Program has provided children’s teaching hospitals with federal support for job training for physicians who care for children. The program was first enacted by Congress in 1999 with bipartisan support and has been reauthorized three times since then, each time with broad bipartisan support. The program provides funding to more than 50 freestanding children’s hospitals around the country to support the training of pediatricians and other residents.
Before the Children’s Hospital Graduate Medical Education Program was created, the number of residents who trained in freestanding children’s hospitals declined by more than 13 percent. The Children’s Hospital Graduate Medical Education Program has reversed that trend and today these hospitals train approximately half of all pediatricians.