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AMA Calls for DTC Advertising Ban

Nov. 17, 2015 — The American Medical Association (AMA) announced today that it would support an advertising ban on direct-to-consumer ... read more

Rocky Political Road Ahead for Pharma Industry

Nov. 16, 2015 – From tax inversions to the proposal to reduce ad tax deductions for marketing to being named ... read more

PhRMA Puts Drug Costs in Perspective as Pricing Scrutiny Increases

Nov. 9, 2015 – Congress, federal agencies and the media continue to turn up the heat on their examination of ... read more

Kaiser Poll: DTC Ads Have High Profile, But Mixed Reviews

Oct. 30, 2015 – The drug industry may have additional work to do to improve the public’s perception of its ... read more

CHC DC Meeting: Prescription Drugs Are Cost Savers, Not Cost Drivers

Oct. 26, 2015 – There is no question that prescription drugs have a cost to patients and payers, but that ... read more

FDA Study of DTC Ads Reaches Critical Mass

Oct. 20, 2015 – The FDA’s announcement last week that it was accepting comments on two new studies of direct-to-consumer ... read more

Senate Bill Would Loop Nurse Practitioners and PAs into Sunshine Reporting

Oct. 12, 2015 – A bill introduced in the Senate last week by Sen. Charles Grassley (R-Iowa) and Sen. Richard ... read more

Which Standard of Truth Will Be Used To Evaluate Non-misleading Ad Claims?

Oct. 5, 2015 – Following numerous First Amendment court cases about promotional speech decided in favor of pharmaceutical companies, it ... read more

Prescription Drug Marketing Targeted by Hillary Clinton

Sept. 24, 2015 – Presidential hopeful Hillary Clinton just announced that she would “demand a stop to excessive profiteering and ... read more

CMPI: Value of Prescription Drugs Is Underestimated

Sept. 21, 2015 – Despite widespread reports about the soaring prices of prescription drugs and calls by the federal government ... read more

Pacira Files Complaint Calling FDA Marketing Restrictions Unconstitutional

Sept. 10, 2015 – On the heels of last month’s ruling in Amarin v. FDA, which held that the FDA ... read more

Comment Period for Brief Summary Revised Guidance Extended to Oct. 5 Under Second Revision

Sept. 8, 2015 – To incorporate animal prescription drugs into its revised draft guidance on Brief Summary and Adequate Directions ... read more

Pitts Calls Higher Drug Approval Rate a Sign of Regulatory Progress

Aug. 24, 2015 – Although some may call the FDA to task for approving more new drugs than they have ... read more

CHC and CCC Launching Regulatory Compliance University for Agencies, Publishers

Aug. 19, 2015 – The Coalition for Healthcare Communication (CHC) is partnering with the Center for Communication Compliance (CCC) to ... read more

Kamp on Presidential Politics: They Matter to Medical Marketers

Aug. 17, 2015 – In an Aug. 11 column posted on the PharmaLive website, Coalition for Healthcare Communication Executive Director ... read more

Amarin Federal Court Decision: FDA Off-Label Marketing Rules Violate the First Amendment By John Kamp

Aug. 10, 2015 – Late last week the U.S. District Court for the Southern District of New York granted Amarin ... read more

FDA Will Study How Market Claims, Efficacy Info Affect Consumers in DTC Drug Print Ads

July 29, 2015 – The FDA’s Office of Prescription Drug Promotion (OPDP) recently announced that it plans to conduct a ... read more

Congressional Briefing: Medical Information Communication Is Important Patient Issue

July 28, 2015 – Physicians and their patients need access to truthful and non-misleading data about available treatments, including off-label ... read more

CME Update: CMS Revises Guidance and Industry Ups Spending

July 20, 2015 – Two recent developments in the continuing medical education (CME) arena – a revision to CME guidance ... read more

Kamp: 21st Century Cures Act and Amarin Case Developments Are Signs of Progress

July 13, 2015 –Two events last week – the House approval of the 21st Century Cures legislation and arguments in ... read more

House Approves 21st Century Cures Act, Bill Now Heads to the Senate

July 10, 2015 — The House of Representatives today passed H.R. 6, also known as the 21st Century Cures Act, ... read more

21st Century Cures Legislation Garners House Majority Support

July 1, 2015 – The 21st Century Cures Act, which was unanimously approved by the House Energy and Commerce Committee ... read more

Google SEM Changes Affect Drug Black Box Reminder-like, Redirecting Ads

June 29, 2015 – Two changes to search engine marketing (SEM) recently announced by Google could soon alter how pharmaceutical ... read more

Physicians Say CHC-backed H.R. 293 Would Remedy “Burdensome” Sunshine Act Reporting

June 15, 2015 – More than 100 physician organizations have written to Rep. Michael Burgess (R-TX) to express their strong ... read more

Author of “Pharmaphobia” Says Conflict-of-interest Regulations Are Slowing Medical Progress

June 8, 2015 – In his new book, “Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation,” Tom ... read more

Revised Guidance on Use of Brief Summary in Print DTC Ads: Full PI Is Not Needed or “Recommended”

Feb. 9, 2015 – In a revised draft guidance document released Feb. 6, the FDA is updating a 2004 version ... 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 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.