Subscribe   RSS Contact Us

Pines Floats Six Ideas about FDA for Trump Administration Consideration

Dec. 6, 2016 – When the dust settles post-inauguration, the Trump administration likely will be considering how it might want ... read more

Sunshine Clarifications Stripped from 21st Century Cures Act

Special Report and Commentary from Jack Angel, Coalition for Healthcare Communication Education Foundation Executive Director Nov. 30, 2016 – As ... read more

Kamp: Coalition Will Continue to Fight for Free Flow of Information

Nov. 28, 2016 – Although President-elect Donald Trump was not who the Coalition for Healthcare Communication was preparing for in ... read more

Coalition Meeting: Moving Forward in Washington, D.C.

Nov 18, 2016 – Although many in the medical marketing industry were bracing for a post-election drug pricing battle with ... read more

Kamp: Moving forward after the election

Nov. 11, 2016 – Post-election report from Coalition for Healthcare Communication Executive Director John Kamp: The pollsters and pundits sure ... read more

Speakers at FDA Off-label Hearing Call for Action that Protects Free Speech

Nov. 10, 2016 – As FDA Commissioner Robert Califf described the issues surrounding the communication of off-label uses as “numerous ... read more

Report from the Coalition Executive Director

Nov. 8, 2016 – When the votes are counted, expect many discussions on what will happen next. One thing is ... read more

Kamp to Urge FDA to Provide Clear Guidance on Off-label Communication at November Hearing

Oct. 31, 2016 – In testimony at the upcoming off-label hearing at the FDA, Coalition for Healthcare Communication Executive Director ... read more

Jenkins to Speak at CHC’s D.C. Meeting

Oct. 27, 2016 — Pam Jenkins, president of Powell Tate/Weber Shandwick, will be the keynote speaker at the Nov. 16 ... read more

Coalition Commentary: How Information Flows … or Doesn’t

Commentary from Jack Angel, Coalition for Healthcare Communication Education Foundation Executive Director Oct. 25, 2016 – The Coalition for Healthcare ... read more

Kamp: Pharma Needs to Step up to Stem Opioid Abuse

Oct. 17, 2016 – In a recent guest commentary in PM360, Coalition for Healthcare Communication Executive Director John Kamp praised ... read more

CMS Clarifies Sunshine Act CME Exclusion

Oct. 6, 2016 – The Centers for Medicare & Medicaid Services (CMS) recently clarified in a revised FAQ that manufacturers ... read more

OPDP’s Abrams: Enforcement Still a Priority, Despite Decrease in Letters

Oct. 3, 2016 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has issued just four enforcement letters in ... read more

OPDP’s Second Enforcement Letter in Two Weeks Targets Investigational Drug

Sept. 15, 2016 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has only issued four enforcement letters this ... read more

OPDP Sends Enforcement Letter for Promotion of Investigational Drug

Sept. 8, 2016 — The FDA’s Office of Prescription Drug Promotion (OPDP) takes issue with a conference panel for an ... read more

FDA to Hold Post-election Hearing on Off-label Communication

Sept. 1, 2016 – In the wake of the agency’s recent settlement with Amarin and other rulings that support the ... read more

FDA May Still Issue Four Advertising Guidances in 2016

Aug. 11, 2016 — The FDA announced Aug. 10 that it plans to issue four, much-awaited advertising-related guidance documents before ... read more

Study Shows ACA Increases Use of Rx Drugs, Decreases Out-of-pocket Spending

Aug. 19, 2016 – The Affordable Care Act (ACA) has resulted in increases in the use of prescription drugs and ... read more

Gender and Healthcare Communications

By Nick Colucci, Publicis Health CEO July 21, 2016 — I was moved by a recent op-ed in The New ... read more

Medical Associations Support Bill Exempting Journals and Textbooks from Sunshine Reporting

July 15, 2016 – More than 100 medical associations, including the American Medical Association, signed a letter of support for ... read more

Pfizer Gets in Front of Opioid Marketing Issue

July 8, 2016 – As organized medicine, politicians and the public seek to reverse the scourge of opioid addiction, Pfizer ... read more

CEOs to Coalition’s Rising Leaders: Engage in Political Process, Keep Learning

June 17, 2016 – In order to stay ahead of change, further their careers and forward the positive message of ... read more

Davidson Sums Up Past and Current State of DTC Ad Restrictions, Ad Tax Deduction

June 7, 2016 – The Advertising Coalition (TAC) Executive Director Jim Davidson gave industry’s next generation a comprehensive overview of ... read more

Congressman Jenkins to Coalition’s Rising Leaders: You Have the Power to Influence Lawmakers

May 24, 2016 – At a recent Coalition for Healthcare Communication Rising Leaders Conference, keynote speaker Rep. Evan Jenkins (R-W. ... read more

NYTimes: Ban on Drug Ads Would Also Eliminate Ad Benefits

March 14, 2016 — The American Medical Association (AMA) as well as Rep. Rosa DeLauro (D-Conn.) and Sen. Al Franken ... 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

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

Previous Next

Call for Industry Comments: Proposed FDA Study on “Corrective” DTC TV Advertising

March 26, 2012 – Note to Industry Leaders

The Coalition for Healthcare Communication needs your input on a study FDA is planning to conduct regarding corrective DTC television advertising. In the recent past, FDA has used this enforcement tool only sparingly, most notably as part of a Warning Letter involving contraceptives. Our primary concern is that FDA may be fielding this study to support more extensive use of this extraordinary remedy.

FDA has asked for comments on the following corrective advertising study issues:

  • Whether the study is necessary
  • Whether the cost estimates are accurate
  • Ways to enhance the study
  • Ways to reduce the cost

To inform the Coalition comment to FDA, we would like to hear from you on the impact of corrective ads, especially on whether or not corrective ads achieve the intended goals of the FDA and whether or not they may be counterproductive. We would like to include data supporting our comments and recommendations wherever possible.

Background

Corrective advertising was born in the 1970s as a hypothetical remedy for deceptive advertising. The Federal Trade Commission requires it only in extraordinary cases because it is controversial and is subject to limits under the First Amendment. At FDA, corrective advertising has been used in both professional and consumer advertising, but there exist very limited public data on its impact.

FDA’s Stated Objective

To examine how variations in corrective advertising may impact consumer understanding.

Study Design

FDA proposes to use an Internet panel asking questions online. There would be two phases:

  • Phase 1 – Examination of the impact of exposure to combinations of the original and corrective ad.
  • Phase 2 – Examination of how the similarity of the original and the corrective ads and the time between their use impact the ability to correct misinformation.

FDA says that there will be no capital or operating and maintenance costs associated with this collection of information.

What You Can Do

If you want more details on the plan, go to the Federal Register/Vol. 77, No. 40 published Feb. 29, 2012. You may wish to pass this message along to those in your organization who focus on market research, requesting comments and suggestions.

Agencies and publishers may choose to comment individually, as well as to support the Coalition comment.

For our part, we are seeking data and information from communication professionals on just how FDA’s use of

corrective advertising action might impact consumer perception and behavior. The FDA would be especially interested in data that demonstrate the limits and possible unintended consequences of requiring corrective advertising in its enforcement actions.

Deadline

Comments must be filed with FDA by April 29, 2012. We would like your views and suggestions by April 6th so we can consolidate and prepare our final comments. Interested members should contact Jack Angel at jeangel@cohealthcom.org or 203-661-3314.

In addition, you will soon receive a similar request to support Coalition comments on the recently released draft guidance on pre-review of DTC advertising. That comment is due May 15.

Jack Angel & John Kamp
Coalition for Healthcare Communication