On December 23, 2022, President Joe Biden officially signed the Consolidated Appropriations Act, 2023. This bill sets in stone the federal government’s budget for the year, so naturally it includes a lot of important provisions. Research!America, a Patient Worthy partner organization, has shared a press release about the new law. As for aspects that are relevant for the rare disease community, the law includes significant increases in funding for a number of federal agencies focused on scientific and medical research.
This handy chart below demonstrates the increases in funding when compared to 2022:
The EveryLife Foundation for Rare Diseases also highlighted some other provisions that stand to benefit the rare disease community, such as:
- Funding for a study led by the National Academy of Medicine focused on newborn screening and how it can be improved
- Reauthorizing the Orphan Products Grants Program, which includes new regulatory science challenges for future grants
- Much needed reforms to the Accelerated Approval pathway that will allow it to be more effective and improve the speed at which patients can receive new treatments
- Policies designed to improve diversity in clinical trials
- Guidelines for communications between payors and drug manufacturers before a drug is approved
- Improvements to coverage of genetic testing to children on Medicaid
- Requirements for new studies from the FDA detailing the incorporation of external expert advice when evaluating rare disease therapies for approval
- Extension of telehealth abilities for two years for patients using Medicaid or Medicare that have been implemented since the beginning of COVID-19.
In the hustle and bustle on Capitol Hill, it can be easy for the needs of the rare disease community to get buried under more media-grabbing hot button issues, but these provisions in the 2023 spending bill are significant advancements for the needs of the rare disease patient community.
