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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Sept. 8, 2015 – To incorporate animal prescription drugs into its revised draft guidance on Brief Summary and Adequate Directions ...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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White Paper Examines FDA Enforcement in Digital, Social Media Realm

April 4, 2013 – A new White Paper, “,” issued April 2 by Eye on FDA/Fleishman-Hillard, is based on analysis of a database of FDA/Office of Prescription Drug Promotion (OPDP) enforcement letters, and takes a close look at how, in the absence of FDA guidance on digital communications and social media, the agency enforces alleged violations in these media.

“Lacking any sort of formal guidance from the agency, the only peek into FDA’s point of view is to examine enforcement patterns,” according to Mark Senak, Eye on FDA author and Senior Vice President & Partner, Fleishman-Hillard. For the period of 2008-2012, Senak set out to determine how violations by digital communications properties compared to violations by traditional (non-digital) communications vehicles.

“Given the lack of guidance by the FDA, an examination of regulatory action letters over the period of time during which social media became prominent could provide oversight into (1) whether digital communications led to a change in regulatory actions and (2) potential agency points of view derived from action letters involving social media,” the White Paper states.

Of the 173 letters sent by OPDP during this time period, 26 percent involved the issuance of a Warning Letter and 74 percent were Notices of Violation. Of the 45 Warning Letters issued, only 12 cited digital communications vehicles, the report states, and only a single enforcement letter has been issued regarding a social media platform. In that letter, it was the nature of the social media mechanism that brought about the violation, the author notes.

“As more and more people utilize digital and social media to get healthcare information, getting information about the regulatory parameters in which industry can operate is extremely important,” said John Kamp, Executive Director of the Coalition for Healthcare Communication.  “There are still more questions than answers, but this paper sheds some important light onto the patterns of enforcement of digital over non-digital communications.”