“A bill to provide for digital communication of prescribing information for drugs (including biological products), and for other purposes.”
No CRS summary available for this bill.
This section amends the labeling requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) to permit required prescribing information (i.e., FDA-approved package inserts) for prescription drugs (those subject to FFDCA section 503(b)(1), including biological products) to be provided solely by electronic means, provided the labeling complies with all applicable legal requirements, manufacturers offer prescribers and dispensers the option to elect ongoing paper copies or request them on an as-needed basis, and manufacturers promptly supply requested paper copies at no additional cost. This section directs the Secretary of Health and Human Services to issue final regulations within one year of enactment to implement the amendment and provide instructions for health care professionals to obtain paper copies directly from manufacturers or distributors, minimizing adverse economic impacts on prescribers and dispensers. This section requires the Secretary, acting through the FDA Commissioner, to hold a public workshop with stakeholders within two years of enactment to discuss optimizing the format, accessibility, and usability of prescribing information. The amendment applies to drugs introduced or delivered for introduction into interstate commerce on or after the sooner of two years after enactment or the effective date of the implementing regulations.