Sens. Isakson, Casey Applaud Committee Passage of Public Health Legislation
The Over-the-Counter Drug Safety, Innovation, and Reform Act, S.2315, was approved 22-1 by the
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
"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Drug Safety, Innovation, and Reform Act passed by committee today to overhaul and modernize our woefully outdated over-the-counter drug approval process is a long time coming," said Isakson.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
"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
The current system used by the
The Over-the-Counter Drug Safety, Innovation, and Reform Act seeks to streamline and modernize the
Background:
Isakson and Casey's Over-the-Counter Drug Safety, Innovation, and Reform Act, which was introduced on
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
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
* Establish processes for manufacturers to request administrative orders, or for the secretary to initiate administrative orders at the recommendation of the
* Establish a process by which drug developers can request meetings with the
* 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
* Authorize the
The full text of the legislation can be found here: https://www.isakson.senate.gov/public/_cache/files/113414af-4688-4174-97da-7d7df43f3704/01-18-18%20OTC%20Senate%20legislation%20as%20introduced.pdf
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
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.
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