Support the Speeding Therapy Access Today (STAT) Act
In March 2021, Congress introduced a bipartisan bill that will improve the development of treatments and access to therapies for those suffering from rare disease conditions. Called the STAT Act (H.R. 1730/S. 670), the bill seeks reforms within the Food and Drug Administration (FDA)’s drug approval process that will expedite approvals for rare disease therapies and facilitate patient access to those therapies.
How Will This Be Achieved?
While there are several thousand unique rare diseases that we know of, they share similar challenges when it comes to efficient treatments. One of the provisions within the STAT Act will allow for the creation of a rare disease–focused Center of Excellence within the FDA that will provide expertise and resources to reviewers and make it easier for various divisions within the organization to share knowledge and provide solutions to benefit the rare disease drug development process.
The Act will also pave the way for a Rare Disease and Condition Advisory Committee—which will include rare disease experts and patient representatives—that will advise the Health and Human Services Secretary on matters related to regulatory pathways, clinical trial design, biomarker selection, etc. in the rare disease space.
Other provisions in the STAT Act include creating programs for ultra-rare diseases by providing policy recommendations and programmatic grants. Finally, there will be efforts to ensure that insurance coverage policies adequately reflect what the FDA identifies as the target population for the drugs.
Fill out the form below to lend your support to the STAT Act 2021!
The goal is to urge your congressional representative to support the bill.
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