H. R. 1503
IN THE HOUSE OF REPRESENTATIVES
March 9, 2023
Mrs. Harshbarger (for herself and Ms. Sherrill) introduced the following bill; which was referred to the Committee on Energy and Commerce
To provide for digital communication of prescribing information for drugs (including biological products), and for other purposes.
This Act may be cited as the
Prescription Information Modernization Act of 2023.
Digital communication of FDA-approved prescribing information for drugs (including biological products)
Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) is amended by adding at the end the following:
Required prescribing information for drugs subject to section 503(b)(1) may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law, that the manufacturer affords prescribers and dispensers the opportunity to elect to also continue to receive all such information in paper form, or to request paper labeling on an as-needed basis, and after such request, and that the manufacturer promptly provides the requested information without additional cost..
Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue final regulations to—
implement the amendment made by subsection (a); and
provide instructions on how health care professionals can receive paper copies of prescribing information directly from the manufacturer or distributor if desired.
The Secretary of Health and Human Services shall design the regulations required by paragraph (1) so as to minimize the adverse economic impacts of such regulations on prescribers and dispensers.
Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall hold a public workshop with relevant stakeholders to discuss how to continue to optimize the format, accessibility, and usability of prescribing information.
The amendment made by subsection (a) shall apply with respect to drugs introduced or delivered for introduction into interstate commerce on or after the sooner of—
the date that is 2 years after the date of the enactment of this Act; or
the effective date of the final regulations promulgated to implement such amendment.
In this section, the term drug has the meaning given to such term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).