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Socializing Medicine – FDA Enforcement Involving Social Media

Socializing Medicine – FDA Enforcement Involving Social Media | Pharma Advertising | Scoop.it
Have you ever had a conversation with someone who said pharma needs to stay away from social media because it is too risky? Even today, some hold that opinion.
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Promotion of Investigational Compound – Historical Overview

Promotion of Investigational Compound – Historical Overview | Pharma Advertising | Scoop.it
Communications regarding medicines in development – often referred to as “investigational compounds” can be particularly challenging.
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You Can Pay Now or You Will Pay Later: FDA Issues a Warning Letter to a Pharmaceutical Company for a Misleading Patient Co-Pay Assistance Voucher | JD Supra

On March 29, 2016, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to a pharmaceutical company for a patient co-pa
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OPDP slams print ad in Untitled Letter

OPDP slams print ad in Untitled Letter | Pharma Advertising | Scoop.it
The FDAs prescription drug promotion arm wrote that the professional print ad for seizure med Aptiom misleadingly overstated its efficacy.
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Batting down generic plaintiffs' Amarin Hail Mary pass - Lexology (registration)

Batting down generic plaintiffs' Amarin Hail Mary pass - Lexology (registration) | Pharma Advertising | Scoop.it
We received a couple of odd anonymous comments to our "breaking news" post about the Amarin First Amendment victory for truthful off-label promotion…
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Whither Off-Label Communications Policy? - Pharmaceutical Executive (press release) (registration) (blog)

Whither Off-Label Communications Policy? - Pharmaceutical Executive (press release) (registration) (blog) | Pharma Advertising | Scoop.it
Amarin ruling puts pressure on FDA to reassess marketing rules, writes Jill Wechsler.
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Banner triggers OPDP letter to Oak Pharmaceuticals

Banner triggers OPDP letter to Oak Pharmaceuticals | Pharma Advertising | Scoop.it
The FDAs badad group said the banner they saw at a professional conference was misleading.
Darshan's insight:
#badad #fdalaw #advertising
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OPDP finds fault with Rapaflo website - Medical Marketing and Media

OPDP finds fault with Rapaflo website - Medical Marketing and Media | Pharma Advertising | Scoop.it
The FDAs advertising division said images and copy for the BPH drug Rapaflo are misleading.
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OPDP Issues Warning Letter on Social Media Posting | Eye on FDA

OPDP Issues Warning Letter on Social Media Posting | Eye on FDA | Pharma Advertising | Scoop.it
I like http://t.co/3KU6Rxp3bt
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Editor's Desk: Kim Kardashian West's tempest in a bottle - Medical Marketing and Media

Editor's Desk: Kim Kardashian West's tempest in a bottle - Medical Marketing and Media | Pharma Advertising | Scoop.it
Could Kardashian Wests nownotorious social post be more than an OPDP case study
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Collection of FDA and Social Media Resources

Collection of FDA and Social Media Resources | Pharma Advertising | Scoop.it

Many years have passed since FDA began attempting to enunciate a regulatory approach to digital and social media – beginning in 2009 and still presumably on-going.  In June the most substantive guidance yet was released by the agency addressing two critical areas that were outstanding – the correction of misinformation by third parties about prescription products and medical devices, and addressing the challenges of including risk information in product specific communications where there are character limitations.

With the passage of so much time, however, and since digital and social media are expansive topics, it is somewhat difficult to keep track of everything that has occurred.  To help in that regard, I’ve put together a tab on the Eye on FDA blog site that contains the following:

Compilation of all relevant guidancesLinks to relevant Warning and Untitled LettersA link to my White Paper on the Regulation of Digital Media by FDA which compares enforcement patterns by OPDP for digital and non-digital communications vehicles;Links to relevant pages on the FDA site that pertain to the regulation of digital media

If there are any other resources on the FDA site that I have overlooked, by all means I welcome suggestions.  In the meantime, I hope you will find this a useful resource.

Also, if you haven’t done so yet, there is still time to sign up for my free Webinar being given this Thursday, July 17 at 12 Noon E.S.T. – “In More than 140 Characters – FDA’s Social Media Guidance:  Past, Present and Future” where I will be taking a comprehensive look at FDA’s approach to regulating social media by examining each of the five questions raised in the November 2009 hearing held on the topic.


Via Plus91, Lionel Reichardt / le Pharmageek
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Gina Tucker's curator insight, July 25, 2014 5:47 PM

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Recent Warning Letters - Mondaq News Alerts (registration)

Recent Warning Letters - Mondaq News Alerts (registration) | Pharma Advertising | Scoop.it
Recent Warning Letters
Mondaq News Alerts (registration)
According to its website, the Office of Prescription Drug Promotion ("OPDP") has issued no warning letters in the last 60 days. Click here for a complete listing of 2014 OPDP Warning Letters.
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OPDP targets omission of risk information in recent enforcement letters

OPDP targets omission of risk information in recent enforcement letters | Pharma Advertising | Scoop.it
The three enforcement letters sent by the FDA's Office of Prescription Drug Promotion (OPDP) to drug companies this year all address omission of risk information, according to an article posted on the Coalition for Healthcare Communication's website.
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OPDP Issues Warning Letter to Shionogi for False or Misleading Advertising

OPDP Issues Warning Letter to Shionogi for False or Misleading Advertising | Pharma Advertising | Scoop.it
The Office of Prescription Drug Promotion issued a warning letter to Shionogi, for omitting risks and material facts, for its head-lice lotion Ulesfia in a patient co-pay assistance voucher.
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Comparative Claims in Video Ads Make Drugs Seem Safer, More Effective Says FDA Study | PrivatePractice

Comparative Claims in Video Ads Make Drugs Seem Safer, More Effective Says FDA Study | PrivatePractice | Pharma Advertising | Scoop.it
Using comparative claims in drug advertisements can make them more effective at persuading consumers that a drug is safer and more effective than the drug it’s being compared to, according to new research conducted by the US Food and Drug...
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Comparative Effectiveness of Generic Atorvastatin and Lipitor® in Patients Hospitalized with an Acute Coronary Syndrome

Comparative Effectiveness of Generic Atorvastatin and Lipitor® in Patients Hospitalized with an Acute Coronary Syndrome | Pharma Advertising | Scoop.it
Journal of the American Heart Association (JAHA) is an authoritative, peer-reviewed Open Access journal focusing on cardiovascular and cerebrovascular disease
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OPDP finds many flaws with Luitpold video - Medical Marketing and Media

OPDP finds many flaws with Luitpold video - Medical Marketing and Media | Pharma Advertising | Scoop.it
The list of objections by the Office of Prescription Drug Promotion, which oversees medical advertising, is a familiar one, and includes concerns such as claims that go beyond the approved indication.
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Pacira Files Lawsuit vs. FDA Over Exparel Marketing - Zacks.com

Pacira Files Lawsuit vs. FDA Over Exparel Marketing - Zacks.com | Pharma Advertising | Scoop.it
Pacira Pharmaceuticals (PCRX) filed a lawsuit against the FDA seeking a court ruling to defend its rights to promote Exparel for the approved indication.
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Trend watch: First Amendment challenges to FDA promotional requirements continue - Lexology (registration)

Trend watch: First Amendment challenges to FDA promotional requirements continue - Lexology (registration) | Pharma Advertising | Scoop.it
In the wake of Amarin Pharma’s victory in securing a preliminary injunction against the Food and Drug Administration’s (FDA) prohibition of off-label…
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OPDP to study the impact of comparative pricing information in DTC and ... - Lexology (registration)

OPDP to study the impact of comparative pricing information in DTC and ... - Lexology (registration) | Pharma Advertising | Scoop.it
The agency will investigate how prescription drug product perceptions are impacted by the inclusion of price comparison information and supplementary…
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FDA to study impact of efficacy information in DTC ads - Pharmaceutical Processing

FDA to study impact of efficacy information in DTC ads - Pharmaceutical Processing | Pharma Advertising | Scoop.it
In its latest study of direct-to-consumer ads, the FDA wants to know if the inclusion of efficacy information in drug advertisements affects how patients perceive the drug. For the two-part study announced Monday ...
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OPDP Warning Letter Targets Social Media Campaign - Food, Drugs, Healthcare, Life Sciences - United States

OPDP Warning Letter Targets Social Media Campaign - Food, Drugs, Healthcare, Life Sciences - United States | Pharma Advertising | Scoop.it
FDA's Office of Prescription Drug Promotion (OPDP) issued two warning letters regarding pharmaceutical product promotion in a two-week timeframe, most recently citing social media posts.
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The FDA is Cracking Down on Big Pharma Social Media - TIME

The FDA is Cracking Down on Big Pharma Social Media - TIME | Pharma Advertising | Scoop.it
The FDA is Cracking Down on Big Pharma Social Media
TIME
The FDA often sends warning letters to companies for violating FDA regulation on how their products are marketed.

Via Thomas Faltin
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After Quiet Quarter, OPDP Releases New Untitled Letter for Familiar Reasons

For the first time in nearly three months, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has released a new Untitled Letter, this time alleging that a (RT @AlecGaffney: After Quiet Quarter, OPDP Releases ...
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FDA seeks comments on proposed comparative price information study - Lexology (registration)

FDA seeks comments on proposed comparative price information study - Lexology (registration) | Pharma Advertising | Scoop.it
FDA seeks comments on proposed comparative price information study Lexology (registration) The FDA's Office of Prescription Drug Promotion (OPDP) will investigate the impact of price comparison information to better understand how the information...
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