DREDF Submits Comments Opposing HHS’ Proposed Regulatory “Sunset Rule”

December 4, 2020
DREDF submitted comments on HHS' proposed "Sunset Rule," which would impose an automatic expiration date on most HHS regulations unless the agency completes a detailed review and determines to retain it. DREDF's comments urge HHS to immediately withdraw the proposal, as it would create a tremendous administrative burden for HHS and create chaos across HHS programs and regulated entities, including Medicaid, Medicare, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). DREDF's comments detail how this increased burden could cause regulations essential to the health care needs of people with disabilities to be arbitrarily rescinded. [...]

Comments on FDASIA Section 907 Report

November 20, 2013
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) that underlies both the FDA report and the Action Plan explicitly mentions sex, age, racial, and ethnic subgroup characteristics, but the use of language like "including" and "such as" in Section 907 of the act clearly indicates that the FDA was not given an exhaustive list to consider when assessing the extent to which clinical trial preparation and safety and effectiveness data take demographic subgroups into account. As such, the FDA's lack of consideration of disability in its recent report is a choice, and it is not a choice that can go unremarked.