Prescription Information Modernization Act

Summary#

This bill lets required prescribing information for drugs (including biological products) be provided only by electronic means in some cases. It changes section 502(f) of the Federal Food, Drug, and Cosmetic Act so that manufacturers may make prescribing information available electronically for drugs subject to section 503(b)(1), as long as the labeling meets legal requirements. Manufacturers must give prescribers and dispensers the chance to choose to keep receiving paper copies or to request paper labeling when needed, and must promptly provide requested paper information without extra cost.

The Secretary of Health and Human Services must issue final regulations within 1 year to put the change into practice and explain how health care professionals can get paper copies directly from manufacturers or distributors. The regulations must be designed to minimize adverse economic impacts on prescribers and dispensers. The Secretary must also hold a public workshop within 2 years to discuss improving the format, accessibility, and usability of prescribing information. The rule applies to drugs introduced or delivered for introduction into interstate commerce on or after the earlier of (1) 2 years after enactment or (2) the effective date of the final regulations. The bill uses the existing definition of "drug" from the FD&C Act.

What it means for you#

• If you are a prescriber or dispenser: You may receive FDA-approved prescribing information electronically instead of in paper. You must be offered the option to keep getting paper copies or to request paper copies as needed. When you ask for paper labeling, the manufacturer must provide it at no extra cost.
• If you are a drug manufacturer or distributor: You may make required prescribing information available electronically, but you must offer paper options and promptly provide paper copies on request without additional charge. You will need to follow regulations the HHS Secretary issues.
• If you are a member of the public or a patient: The bill focuses on how prescribing information is given to health care professionals. No direct changes to patient-specific rules are described in the bill text.

Expenses#

The bill requires manufacturers to provide requested paper copies to prescribers and dispensers without additional cost. The bill also requires HHS to write regulations and hold a public workshop. There is no publicly available information in the provided text about estimated federal costs, overall economic effects, or detailed costs to manufacturers or other parties.

Proponents' View#

No publicly available information.

Opponents' View#

No publicly available information.