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In Amicus Brief, PhRMA Says Off-label Case “Raises Serious First Amendment Concerns”

Sept. 19, 2014 – Stating that a whistleblower’s interpretation of the False Claims Act has “a critical flaw” because it ... read more

Pfizer’s Susman to Talk Public/Private Partnerships at Nov. 10 Coalition Briefing

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CMS Bombarded with Comments Calling for CME Exemption to Remain

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Coalition Comment to CMS: Keep CME Exemption Under Sunshine Act

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Open Payments Website Reopened, Dispute Period Extended and One-third of Records Withheld

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Medical Groups Ask CMS to Make Changes to Sunshine Act Implementation

Doctors Recommend Fixes to CME Exemption Elimination, Educational Materials Provision Aug. 6, 2014 – More than 100 medical associations and ... read more

Doctor Tells Congress That Communication Is Hampered by FDA, CMS Practices

July 28, 2014 – FDA and Centers for Medicare & Medicaid Services (CMS) policies are barriers to ongoing evidence development ... read more

FDA Plans to Study Effect of DTC Ads on Adolescents

July 24, 2014 – A better understanding of how adolescents weigh risks and benefits in direct-to-consumer (DTC) ads is needed ... read more

Bruce Grant Urges Pharma Communicators to Recognize Their Role in Health Advances

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FDA Social Media Draft Guidances Answer Some Questions, Raise Others

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Kamp to Washington Post: Companies Should Be Able to Speak Truthfully About Drugs

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FDA Device Document Revises Mobile Medical Apps Guidance

July 1, 2014 – The FDA’s recently issued draft guidance on medical device data systems (MDDS) not only lessens the ... read more

New FDA Social Media Guidances Address Space-limited Media, Correcting Online Misinformation

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AMA House of Delegates: Revise Sunshine Act Rules on Textbook/Reprints and TOV Amount

June 12, 2014 – The American Medical Association’s (AMA’s) House of Delegates is attempting to bring some common sense to ... read more

House Committee Seeks Patient Input on Availability of Treatments

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FDA To Study Viewers’ Responses to DTC Ad Risk Information

May 29, 2014 – The FDA announced May 28 in the Federal Register that it plans to conduct an eye ... read more

WLF: FDA’s Revised Reprint Draft Guidance Violates Injunction and First Amendment

May 19, 2014 – In May 15 comments to the FDA regarding its draft guidance on reprint practices for articles ... read more

CHC Comment to FDA: Less Is More in DTC TV Ads

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FDA Willing to “Re-examine” Off-label Policies in Light of First Amendment Rulings

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New Tax Reform Legislation Includes Limit on Ad Tax Deductions

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FDA Is Considering Shorter List of Risks in DTC TV Ad Major Statement

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Caronia Decision One Year Later: Off-label Change May Be Slow, But It’s Brewing

Jan. 27, 2014 – Although FDA officials have treated the U.S. Court of Appeals for the Second Circuit decision in ... read more

Coalition Calls on Senators to Reject Tax on Advertising

Dec. 16, 2013 – Today the Coalition for Healthcare Communication sent a letter to U.S. Senators and Members of the ... read more

OPDP Sends Warning Letter Based on Statements Made on Fast Money TV Show

Nov. 11, 2013 – The FDA Office of Prescription Drug Promotion’s (OPDP’s) recent enforcement actions – four Untitled Letters and ... read more

Physician Organizations, Medical Societies Implore HHS to Reverse Policy on Reprints and Textbooks

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MIWG Asks FDA to Clarify Position Regarding Manufacturer Dissemination of New Use Information

Sept. 16, 2013 – The Medical Information Working Group (MIWG), a coalition of medical product manufacturers seeking to improve the ... read more

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FDA Responds to Comments on Proposed Corrective DTC Advertising Study

Jan. 3, 2013 – In the FDA’s view, researchers and policymakers “currently lack empirical viagra online without prescription literature regarding the various influences” of corrective direct-to-consumer (DTC) advertising on prescription drug consumers. To forward the development of this literature, the FDA’s plans to conduct an experimental study on this issue are moving forward.

In a Dec. 26, 2012, Federal Register notice, the agency reiterates its corrective DTC advertising study design overview, sets forth the information collection requirements for the study, and responds to comments received on the initial study proposal published on Feb. 29, 2012.

“I’m optimistic that the FDA, like the FTC, clearly understands that ‘corrective advertising’ is an extraordinary remedy to be applied only to violations that are extraordinary,” said John Kamp, Executive Director, Coalition for Healthcare Communication.   

The study, which will

be administered over the Internet, will include 6,650 interviews of randomly assigned participants. Phase 1 of the study will vary exposure to advertising messages about asthma to examine how a combination of original and corrective DTC ads affects message recall, message comprehension, perceived drug efficacy, perceived drug risk and intentions to ask about or use the drug. Phase 2 will examine the similarity of the corrective ad’s theme and visual elements to those of the original ad for weight-loss products, as well as the exposure delay (time) between viewing the original ad and the corrective ad.

In response to a comment suggesting that the study not examine similarity and time delay but instead

evaluate “a truly informative, nondistracting, clear and conspicuous corrective ad” and “an unclear and inconspicuous corrective ad,” the FDA stated that although it appreciated the suggestion to include clarity as a variable in the study, it selected similarity and time delay as its independent variables to “provide information on the effectiveness of FDA guidance on this issue.”

Two comments also expressed concerns that the time delay conditions as proposed were not realistic and stated that a six-month time delay would be more realistic. The agency agreed that a six-month exposure delay “more closely approximates real-world exposure to original and corrective messaging” and has changed the study accordingly by embedding the stimuli in a “clutter reel” to approximate real-world experience and by adding a six-month delay condition.

The FDA concludes the notice by stating that the study was designed “to address a gap in the literature – there is scant work on the specific efficacy of televised corrective ads intended to address claims made regarding prescription drugs – rather than to simply extend and replicate past literature.”

Written comments on this notice will be accepted by the agency via fax until Jan. 25. See the Dec. 26 notice for details.canine lasix doseage