- Prescription Medication (http://dev-voice.ons.org/topic/prescription-medication)
- Patient Safety (http://dev-voice.ons.org/topic/patient-safety)
- Patient Advocacy (http://dev-voice.ons.org/topic/patient-advocacy)
- U.S. Food and Drug Administration (FDA) (http://dev-voice.ons.org/topic/us-food-and-drug-administration-fda)
Legislation Funds FDA Programs to Support Safety, Lower Costs, and Spur Innovation
To improve safety and regulation for drugs and devices, U.S. Senators Patty Murray (D-WA) and Richard Burr (R-NC) introduced (https://www.help.senate.gov/chair/newsroom/press/senators-murray-burr-release-legislation-to-support-fda-programs-to-lower-costs-and-spur-innovation-) the Safety and Landmark Advancements (FDASLA) Act in May 2022. The act reauthorizes and builds on the U.S. Food and Drug Administration’s (FDA’s) prescription drug, generic drug, biosimilar, and medical device user fee agreements.
The discussion draft outlined (https://www.help.senate.gov/chair/newsroom/press/senators-murray-burr-release-legislation-to-support-fda-programs-to-lower-costs-and-spur-innovation-) steps for expanding FDA’s oversight of the agreements and in:
- Strengthening observation of cosmetics and dietary supplements
- Improving regulation of diagnostic tests
- Lowering prices through competition in the drug marketplace
- Ensuring safer drug disposal
- Modernizing data used in medical product development
- Expanding the hiring authorized by the 21st Century Cures Act
- Requiring a plan to help strengthen FDA’s workforce
- Ensuring FDA is transparent and accountable for its user fees
“Families want to know the products they entrust their health to are safe and effective, which is why this bipartisan legislation is so important,” Murray said (https://www.help.senate.gov/chair/newsroom/press/senators-murray-burr-release-legislation-to-support-fda-programs-to-lower-costs-and-spur-innovation-). “This legislation will ensure FDA has the resources it needs to do its work and will enable the agency to finally provide serious oversight of the cosmetics and dietary supplements people in Washington state use every day.”
“It’s essential that the agency use the same urgency to bring life-saving treatments and cures to Americans suffering from other devastating diseases, like cancer or Alzheimer’s,” Burr added (https://www.help.senate.gov/chair/newsroom/press/senators-murray-burr-release-legislation-to-support-fda-programs-to-lower-costs-and-spur-innovation-). “This bipartisan draft strengthens FDA’s foundation to ensure our review and approval process is ready for the next generation of innovative products.”