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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

OPDP Sends Six Enforcement Letters in Six Months

June 23, 2015 – The Office of Prescription Drug Promotion (OPDP) sent just six Untitled Letters to industry for alleged ... 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

New House Bill Would Enable Links in Internet and Social Media

May 27, 2015 — On the heels of the swift approval last week of the 21st Century Cures Act in ... read more

House Energy and Commerce Committee Wholeheartedly Approves 21st Century Cures Act

May 21, 2015 – In a unanimous (51-0) vote today, the House Energy and Commerce Committee approved the 21st Century ... read more

21st Century Cures Legislation Poised for Full House Committee Vote This Week

May 18, 2015 – Major medical legislation, including closely followed provisions on off-label communication and Sunshine reporting, survived a House ... read more

FDA Plans for Off-label Communication Draft Guidance, Meeting

May 11, 2015 – With off-label provisions in the 21st Century Cures legislation in the works and the courts bearing ... read more

FTC to Industry: Consumer Health Data Subject to Privacy, Security Protections

May 4, 2015 – The Federal Trade Commission (FTC) has issued a reminder to industry members collecting, using or sharing ... read more

PhRMA Authors Call for FDA to Establish Off-label Communication Safe Harbor

April 27, 2015 – Because “sharing more information rather than less” about the off-label uses of approved drugs “is critical ... read more

FDA Draft Guidance Describes Framework for Electronic Submission of Promotional Materials

April 22, 2015 – Healthcare marketers soon will have to submit promotional labeling and advertising materials to the FDA electronically, ... read more

Changing of the Guard at PhRMA

April 20, 2015 – The Pharmaceutical Research and Manufacturers of America (PhRMA) last week announced changes to its board – ... read more

Coalition to Sponsor Medical Marketing Pitch Webinar

April 6, 2015 – The Coalition for Healthcare Communication is sponsoring a Webinar May 6 that will highlight both basic ... read more

2014 DTC Ad Spending on the Rise

March 25, 2015 – The amount of money that drug companies spent on direct-to-consumer advertising rose from $3.8 billion in ... read more

What Does OPDP’s Enforcement Lull Mean?

March 12, 2015 – The FDA’s Office of Prescription Drug Promotion (OPDP) has issued fewer enforcement letters in recent years, ... read more

Who Says You Can’t Fight City Hall?

Commentary from Jack Angel, Coalition for Healthcare Communication Education Foundation Executive Director March 9, 2015 – I am not sure ... read more

DAA Expands Ad Privacy Controls to Mobile Marketplace

Feb. 26, 2015 – To “bolster both consumer trust and marketplace growth,” the Digital Advertising Alliance (DAA) yesterday launched two ... read more

Leveraging Technology and Other Highlights from DIA Marketing Meeting

Feb. 23, 2015 – Dale Cooke, owner of PhillyCooke Consulting, who spoke Feb. 18 at the Drug Information Association’s Marketing ... read more

FDA Budget Increase Relies on Higher User Fees

Feb. 16, 2015 – Although President Obama’s proposed budget for fiscal year 2016 includes increases for both the FDA and ... 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

FDA Commissioner Hamburg to Leave FDA

Feb. 5, 2015 – After serving the FDA for six years, Commissioner of Food and Drugs Margaret Hamburg, M.D., will ... read more

21st Century Cures Discussion Draft Includes Textbook/Reprint Language, Communication Fixes

Jan. 29, 2015 – A 393-page discussion draft of legislation designed to accelerate the 21st Century Cures initiative – released ... read more

Transparency Proponents Slam Company-Provider Communication

Jan. 26, 2015 – Although biomedical companies can legally communicate and share information with physicians under the Physician Payments Sunshine ... read more

FDA Moves Forward with Major Statement Study, Responds to Coalition’s Comments

Jan. 14, 2015 – The FDA is taking the next step toward examining whether shorter, simpler risk disclosures in direct-to-consumer ... read more

Coalition: Issues to Watch in 2015

Jan. 13, 2015 — As 2015 gets fully underway, there are several issues that healthcare marketers should be following, according ... read more

Kamp to WSJ’s Pharmalot: CMS Move on CME “One of Biggest Flip Flops” Ever

Dec. 18, 2014 – This week’s release by the Centers for Medicare & Medicaid Services (CMS) of subregulatory guidance on ... read more

MM&M Tax Reform Prognosis: Stay Tuned

Dec. 4, 2014 — The looming threat of eliminating the marketing tax deduction as part of overall tax reform may ... 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.”