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benefit the public health to update the generic drug labeling at any point after the brand reference-listed drug is withdrawn for reasons other than safety or efficacy (i.e., commercial reasons).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.
The Act establishes the following process for the FDA to identify when a labeling update is needed and to implement that update:
- In order to determine whether labeling updates would provide a public health benefit, the Secretary may
- Enter into cooperative agreements or contracts with public or private entities to review the available scientific evidence concerning the drug; and/or
- Seek public input on the drug, including input on whether there is a relevant accepted use in clinical practice that is not reflected in the approved labeling, or whether new scientific evidence is available regarding the conditions of use, by holding public meetings; opening a public docket for the submission of public comments; or pursuing other means that the Secretary deems appropriate.
- Once information is received by the Secretary as set forth above, and if the Secretary determines that the available scientific evidence meets the standards under section 505 for adding or modifying information to the labeling or providing supplemental information to the labeling regarding the use of the drug, the Secretary may initiate the updating process as follows
- The Secretary shall provide notice to the holders of approved ANDAs that
- Summarizes the findings supporting the Secretary’s determination that the available scientific evidence meets the standards for adding or modifying information or providing supplemental information to the labeling of the drug;
- Provides a clear statement regarding the additional, modified, or supplemental information for the labeling (including, as applicable, modifications to add the relevant accepted use to the labeling of the drug as an additional indication for the drug); and
- Specifies whether the statement applies to the selected drug as a class of covered drugs or only to a specific drug product.
- Within 30 days of receipt of this notification, the ANDA holder shall
- Agree to change the approved labeling to reflect the additional, modified, or supplemental...
- The Secretary shall provide notice to the holders of approved ANDAs that
