Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


DTC Print Ads: Package Insert Info Is Out, Drug Facts Box Is In

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s revised draft guidance for disclosing risk information in direct-to-consumer print ads advises against the use of package insert information in the brief summary; suggests Drugs Facts box or Q&A as alternative formats.

You may also be interested in...

FDA's Rx Promotion Citation Drought Continued In 2015

First Amendment litigation and guidance document work may be factors behind decline.

DTC Print Ads: NEJM, Industry Critique FDA Guidance For Clarifying Risk Info

Article suggests that a Drug Facts box could specify the proportion of patients who benefitted from the drug in key trials and how many had adverse events; PhRMA calls for revision to regulations, preclearance regime.

FDA "Brief Summary" Changes Should Be Written In Regs - PhRMA

DTC draft guidance creates a regulatory "Catch-22" by going against current regulations, PhRMA says in comments. FDA's guidance on disease awareness ads oversteps the agency's authority in regulating unbranded ads, the group asserts.

Related Content





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts