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

UsernamePublicRestriction
UsernamePublicRestriction

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

This article was originally published in RPM Report

Executive Summary

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?

You may also be interested in...



DTC Public Health Slant: A Winning Formula With FDA Commissioner Hamburg

FDA Commissioner Margaret Hamburg is not taking the easy way out when she discusses DTC, even in front of Congressional critics of the practice. She does not treat DTC as primarily a regulatory problem for the agency; instead she likes to focus on the public health potential of DTC.

DTC User Fees Shot Down; Advertisers Face More Perilous Future

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?

DTC Loses Powerful Friends, Will PhRMA Bring Them Back?

Direct-to-consumer advertising is being blamed in large part for the pharmaceutical industry's eroding reputation. Some of the industry's oldest friends in Congress are proposing moratoriums on DTC ads. PhRMA's DTC guidelines may have mollified Congress and FDA for now. However, with the hundreds of billions of dollars lined up for the Medicare drug benefit, CMS could be the newest player in restricting DTC.

Related Content

Topics

UsernamePublicRestriction

Register

PS080674

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

Cancel