This bill lets required prescribing information for prescription drugs be provided only by electronic means. A manufacturer may switch to electronic labeling if the labeling meets legal requirements and the manufacturer gives prescribers and dispensers a chance to keep receiving paper copies or to request paper copies as needed. After a request, the manufacturer must promptly provide the paper copy at no extra cost.
The Secretary of Health and Human Services must issue final rules within 1 year to put the change into effect and to explain how health care professionals can get paper copies directly from manufacturers or distributors. The Secretary must design the rules to minimize adverse economic impacts on prescribers and dispensers. The Food and Drug Administration must hold a public workshop within 2 years to discuss how to improve the format, accessibility, and usability of prescribing information. The change applies to drugs introduced into interstate commerce on or after the earlier of 2 years after enactment or the effective date of the final regulations. The bill uses the existing definition of "drug" from the Federal Food, Drug, and Cosmetic Act.
No publicly available information on total costs or savings from the bill is included in the text. The bill requires manufacturers to provide requested paper copies without additional cost to prescribers or dispensers. The Secretary is directed to design implementing regulations to minimize adverse economic impacts on prescribers and dispensers. The bill does not include an overall federal cost estimate in the text.
No publicly available information in the bill text about proponents’ stated arguments. The bill’s written provisions focus on allowing electronic prescribing information while preserving the option for paper copies and directing HHS rulemaking and a public workshop.
No publicly available information in the bill text about opponents’ stated arguments. The bill text does not record objections or opposing positions.