The Senate Health, Education, Labor and Pensions (HELP) Committee voted on April 6 to advance several bills that make up its biomedical innovations package—a counterpart to the House-passed 21st Century Cures bill that was approved last summer.
Of particular note, the HELP Committee voted in favor of the Promise for Antibiotics and Therapeutics for Health (PATH) Act, S. 185, which would establish a new limited population antibacterial drug (LPAD) approval pathway for antibiotics to treat serious or life-threatening infections for which there exists an unmet medical need. IDSA has led stakeholder groups in advocacy for the PATH Act, including a letter recently urging the HELP Committee to include the legislation in its biomedical innovations effort.
As part of the innovations package, the HELP Committee has approved other bills of interest to the infectious diseases community including:
- Medical Countermeasures Innovation Act of 2015 (S. 2055), which requires the Department of Health and Human Services to develop a budget plan for development of prioritized medical countermeasures, streamline the Project Bioshield procurement process, and provide priority review to encourage the development of novel treatments for agents that present a national security threat;
- Advancing Breakthrough Medical Devices for Patients Act of 2015 (S. 1077), which directs the Food and Drug Administration (FDA) to establish a program to expedite the development and provide for the priority review of breakthrough medical devices;
- Next Generation Researchers Act (S. 2014), which directs the National Institutes of Health to advance policies and programs to improve opportunities for new researchers and promote earlier research independence, and to coordinate with other federal agencies and academic institutions to improve tracking of career progress of biomedical researchers and students;
- Preventing Superbugs and Protecting Patients Act (S. 2503), which requires the FDA to publish a list of reusable devices that would need to provide proposed cleaning instructions as part of a 510(k) pre-market submission process; and
- FDA Device Accountability Act (S. 1622), which helps ensure a more consistent approach to FDA review of new devices, including diagnostic tests.
Advocacy efforts in support of these bills will continue as the package moves on to the full Senate for consideration.
IDSA members are encouraged to visit the Action Center,
where in just three minutes you can send an email urging senators to approve the PATH Act.
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