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



Executive Summary

Rx drug ads should not carry printed promotional messages over full disclosure statements, FDA's Drug Advertising and Labeling Div. advised in a recently issued policy guide. The ad division said it "has become acutely aware of the overprinting of promotional messages and other information on the full disclosure of prescribing information in promotional labeling materials or the corresponding 'brief summary' in prescription drug advertisements." Noting that overprinting has become a common practice, an agency spokesman cited a recent antibiotic ad by Pfizer in which "penetrability" is written in bold red ink over the prescribing information for the drug. FDAers also note that overprinting has also appeared in ads for Wyeth's Triphasil, Ayerst's Inderide-LA, and Squibb's Capoten. The agency asserted that such "overprinting" of promotional messages in bold letters over prescribing information, "even when done in a fairly inconspicuous manner, detracts from the prescribing information required by regulation and changes the emphasis and meaning of information included therein." Therefore, FDA said, "we are advising that this practice be discontinued." FDA based its decision on the FD&C Act authority to proscribe a practice if the practice: "Fails to present information relating to side effects and contraindications with a prominence and readability reasonably comparable with the presentation of information relating to effectiveness of the drug, taking into account all implementing factors such as typography, layout, contrast, headlines, paragraphing, white space, and any other techniques apt to achieve emphasis.'" FDA's Drug Ad Div. used an informal statement to communicate its policy rather than a regulatory action against the offending ads. The ad division described the policy statement as an "informal communication" that "represents the best judgment of the division" and does not represent the formal position of FDA's Center for Drugs and Biologics.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




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