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 User Fees Shot Down; Advertisers Face More Perilous Future

This article was originally published in RPM Report

Executive Summary

The good news for advertisers: FDA will have more resources for pre-review of ads in 2008, funded by the taxpayers. The bad news: what happens in 2009?

You may also be interested in...

Off-Label Communication Growth: Could FDA Afford To Police It?

Another user fee for the US drug agency could help pay for research of off-label uses, but lack of resources could be a regulatory problem.

DTC Held Hostage? FDA Pre-Review of TV Ads May Delay Rx Campaigns

FDA is proposing changes to its regulation of television advertising for prescription drugs with a mandatory pre-review of ads for certain products. The agency says it has the resources to complete all reviews on time. But stakeholders worry that the draft requirements would delay campaigns and make DTC advertising more expensive. It’s not like there’s a good alternative: jumping the gun on DTC carries its own set of risks.

"Neutral" Is "Unbiased" In FDA' s Lexicon: Taking the Buzz and Distractions Out of Risk Statements

FDA is interpreting the new "neutral' standard for direct-to-consumer ads to mean "unbiased." Experts in FDA ad regulation policy are now debating what an advertiser has to do to be unbiased: does it just mean keeping down distractions during the statement of risk information? Or does it mean making an effort not to over-warn?

Related Content


Related Companies




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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