To embed, copy and paste the code into your website or blog: On December 27, 2020, the President signed into law the “Consolidated Appropriations Act, 2021” (the “Act”). Included within this omnibus legislation are several provisions (in Division BB, Title III, Subtitle C) that affect the regulation of generic drugs and biosimilar medicines by the U.S. Food and Drug Administration (FDA). Generic Drug Labeling : The new Section 530D of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), added in Section 324 of Division BB of the Act, creates a process by which the FDA may determine whether it would benefit the public health to update the generic drug labeling at any point after the brand reference-listed drug is withdrawn for reasons other than safety or efficacy (i.e., commercial reasons). In general, FDA can use this process for such drugs when (1) there is new scientific evidence available pertaining to new or existing conditions of use that is not reflected in the approved labeling; (2) the approved labeling does not reflect current legal and regulatory requirements for content or format; and/or (3) there is a relevant accepted use in clinical practice that is not reflected in the approved labeling. Although safety information can be considered as part of the updating process once the above criteria have been met, it cannot be the sole reason for initiating the process.