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Compliance with Regulations & Industry Guidelines

Pharmaguy
The following Pharma Marketing News reprints and case studies relate to "Corporate Compliance/Government Regulation/Industry Guidelines" - compliance with government regulatory laws, industry guidelines, and best practices.You might also be interested in the following category for additional reprints:
John Mack, Publisher & Editor
editor@news.pharma-mkting.com
Reprint List
Accountability for Pharma Content on Social Media Sites
A substantial portion of drug industry comments submitted to the FDA was devoted to how pharmaceutical companies should be held accountable for a communication about its product(s) and how much control they exert over activities on the Internet and social media.

Also see:

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A Few Things I Learned at FDA's Social Media Hearing

What's Next is What Counts

This article presents key takeaways from the FDA hearing, a synopsis of the presentations made by John Mack, Publisher, Pharma Marketing News, at the hearing, a review of Ignite Health's study regarding effectiveness of sponsored links, and the next steps in the process of issuing guidance.

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Applying FDA Marketing Regulations to Internet Promotions

At a recent conference of eMarketing for the Pharmaceutical Industry, Preeti Pinto, M.S., Senior Director Promotional Regulatory Affairs, AstraZeneca, gave the attendees some insight on the regulatory actions taken by the FDA with respect to online DTC marketing by pharmaceutical companies. She summarized the most commonly cited violations found on pharmaceutical company web pages.

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Are Some DTC Print Ads Too Educational and/or Persuasive?

FDA Plans to Do Two Studies to Find Out

Recently, two FDA studies were in the news: "Disease Information in Branded Promotional Material" and "Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions." The focus of both these studies will be on print ads.

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AstraZeneca Hosts First-Ever Twitter Chat

World Does Not End!

Despite dire predictions of 'PR failure,' the #rxsave Twitter chat hosted by @AstraZenecaUS on 15 February 2011 was a great success, which is pharma social media speak for 'did not crash and burn.' It was proof that a pharmaceutical company can indeed host meaningful Twitter chats.

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British Pharma Digital Update

Insider Reactions to Social Media Guidelines from Industry Regulators

This article reports the results of an informal Weber Shandwick survey regarding social media guidelines recently published by the British pharmaceutical industry regulators. It includes advice for how to innovate online without waiting for more specific guidelines from regulators.

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The British Pharmaceutical Industry Issues Social Media Guidance for Adverse Event Reporting

Once again the Brits have beaten the US in issuing useful guidelines for social media use by the pharmaceutical industry! As I reported back in April, 2011, the Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI), published "informal guidance" providing the drug industry advice on how to use online communications.

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Brits Beat FDA and PhRMA: Issue Social Media Guidance for Pharma

Prescription Medicines Code of Practice Authority Issues Social Media Guidance for Pharma.

The Brits have won the race to issue social media guidance for the drug industry! In April, 2011, the Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI), published 'informal guidance' providing the drug industry advice on how to use online communications.

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Capturing & Reporting HCP-Related Meeting Spending

Let the Sunshine In

Life Science companies are struggling to understand the complex reporting requirements and compliance issues presented by existing and new regulations like the Sunshine Act. This article is a summary of a Webinar by StarCite, which defined what pharma marketers and meeting planners need to know when it comes to meetings-related HCP reporting.

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A Case for Pharmaceutical Web Site Accreditation

There are thousands of health Web sites on the Internet. Accreditation is not an appropriate path for all these sites to take, but for those sites that can afford it and that meet rigorous standards for quality and accountability, accreditation can help distinguish them from their competitors and increase consumer trust. Pharmaceutical sites focusing on consumers, in particular, stand to benefit.

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Certain Physician-Drug Industry Relationships Have Declined Dramatically

Sunshine Act May Already Be Causing Sharp Drop in Direct Payments to Physicians

The authors of a physician survey published in the November 8, 2010, issue of Archives of Internal Medicine conclude 'given that 83.8% of physicians have PIRs, it is clear that industry still has substantial financial links with the nation's physicians. These findings support the ongoing need for a national system of disclosure of PIRs [Physician-Drug Industry Relationships].' Such a system is part of the Physician Sunshine Law, which is scheduled to go into effect in 2012 with public disclosure of payments scheduled to begin September, 2013.

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Challenges of Regulating Mobile Medical Apps

Legal and Regulatory Issues You Should Know About

A conversation with Joseph Kim, MD, MPH, VP of Medical Affairs and Technology at Medical Communications Media, Inc., about the rapid development of mobile medical applications and the legal and regulatory issues that physicians, patients, and pharma developers/sponsors should be aware of.

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The Changing Policy Landscape

Prepare Now for the Coming FDA and Pharmaceutical Marketing Reforms

The two traditional means by which pharmaceutical marketers have relied on for many, many years to encourage the uptake of new pharmaceutical products -- direct-to-consumer (DTC) advertising and physician marketing -- are about to change. Prepare now for the coming FDA and pharmaceutical marketing reforms.

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The Changing World of MSLs: Determining Value

This article is an edited transcript of the May 2006, Pharma Marketing Roundtable discussion, which was devoted to exploring issues surrounding the new roles of medical science liaisons (MSLs) and key opinion leader physicians (KOLs) in physician education and product marketing.

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Citizen Petition Likely to Delay FDA Social Media Guidance

Why Now?

Allergan, Eli Lilly, Johnson and Johnson, Novartis, Pfizer, Novo, and Sanofi-Aventis filed a 'citizen petition' with the FDA, urging the agency to 'establish comprehensive, clear and binding regulations to guide the industry' in communicating off-label drug information to physicians and payers. Although the words 'Internet' and 'Social Media' are not mentioned in the petition, it is likely to hold up social media guidelines regarding 'unsolicited requests' that were promised as the first in a series of FDA guidelines.

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Deconstructing Pitts' Guiding Principles for Pharma Social Media

Taking a Closer Look

Peter Pitts, author of DrugWonks Blog, has put together 11 "principles that must serve as the basic substrate of regulated social media participation. This article takes a closer, critical look at "Pitts' Principles" and discusses how successful the pharma industry has been at following these principles to date.

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The Digital Health Coalition

Solving Pharma's Social Media Problems -- Mission Possible?

A conversation with Mark Bard, founder of the Digital Health Coalition, regarding the mission of the Coalition and what companies and individuals are involved.

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Digital Pharma Is Alive and Well in Europe!

Report from DigiPharm Europe 2010

These highlights from the 2010 DigiPharm EU conference summarizes presentations made by marketing specialists from Lundbeck, Janssen, GSK, Schering Plough, Boehringer Ingelheim, Pfizer, Genzyme and Merck Serono. It's a summary of the best current practices and a glimpse at how EU pharma companies are driving digital marketing and communications forward.

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Do Drug Copay Coupons Drive Up Healthcare Costs?

Union Health Plans Say "Yes"

Coupons for drug co-payments are illegal and drive up long-term health-care costs for all, a consumer group and four trade-union health-insurance plans said in announcing lawsuits against eight pharmaceutical companies. The lawsuits claim that although coupons reduce the consumer's out-of-pocket cost, the health insurer still pays the previously negotiated price to the drug company. With no savings from generics, health plans will need to charge patients more to keep up with rising costs, the lawsuits say.

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Do TV DTC Ads Overstate Rx Drug Risks?

FDA Poised to Tip Balance in Favor of Benefits

Specifically, FDA intends to look for evidence that the "major statement" of drug risks as currently implemented in DTC TV ads is often too long and "may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic noncompliance due to fear of side effects."

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Does the FDA Need to be Overhauled

Pharma Marketing News recently hosted a survey of pharmaceutical professionals, healthcare professionals, and the general public to get a better idea which reforms, if any, they would like to see implemented at FDA. The results are summarized in this article.

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DTC Pros and Cons Presented at FDA Hearing

This article summarizes the main points, both pro and con, made by presenters at recent FDA hearing on DTC and includes commentary from expert members of the Pharms Marketing Roundtable, which met to discuss the issues raised at this hearing.

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DTC Risk Communication

With all the new attention being paid to drug risks, it is time to take a look at the issues surrounding drug risk communication to consumers and patients. Pharmaceutical marketers need to understand these issues to better communicate risk and build trust in their brands.

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Evidence-based Direct-To-Consumer Advertising

Pharmaceutical advertising was historically directed toward health care professionals and mainly communicated through medical journals. Rigorous research is needed to evaluate and determine the most effective format for communicating benefit and risk information to consumers. New standards for drug advertising to consumers should be grounded in data derived from this type of research.

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Fair Social Media Practice Principles

Rules for Third-Party Engagement in Patient/Physician Social Networks

A Social Media Policy is not just an agreement that users must abide by. More importantly, it is a PROMISE to users from site owners/sponsors concerning how they will protect or attempt to protect user-generated content, personal conversations, interactions, and engagements with third-parties on the site. These policies should comply with as-yet-to-be-determined, universally accepted "fair social media practice principles."

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FDA Draft Guidance for Print DTCA: Less than Feared

On February 4, 2004, the FDA issued long-awaited draft guidance documents designed to improve communications to consumers and health care practitioners about health conditions and medical products. The most eagerly anticipated guidance concerns the acceptable alternatives to the lengthy, detailed, and technically-written brief summary of risk information for consumer-directed print advertisements for prescription drugs.

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FDA Drops Social Media from Its Guidance Agenda

Focuses Instead on Responsding to "Unsolicited" Off-Label Information Requests

FDA's revised draft guidance calendar for year 2011 is missing 'Promotion of Prescription Drug Products Using Social Media Tools," which WAS on the 2010 Agenda. Included, however, is 'Responding to Unsolicited Requests for Prescription Drug and Medical Device Information, Including Those Encountered on the Internet.' FDA says this includes Internet requests. Why did the FDA put this issue at the TOP of its list of 'issues related to Internet/social media promotion of FDA-regulated medical products' for which it promised guidance? Where did that issue arise? It wasn't mentioned in the Federal Register regarding social media guidance.

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FDA Issues Long-Awaited Guidance for Mobile Medical Apps

Do Some Pharma Mobile Apps Require FDA Approval?

The Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER); responsible for regulating medical devices, have issued guidance for mobile medical applications. The guidance focuses only on a select group of applications. Meanwhile, many pharmaceutical companies, such as Janssen, are developing mobile apps for the iPhone and iPad. Can some of these apps be considered medical devices requiring approval by the FDA?

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FDA Finalizes Guidance on Distribution of Reprints

Clarifies How Manufacturers Can Hand Out Journal Articles to Docs

The FDA recently finalized its Good Reprint Practices for the Distribution of Medical Journal Articles. This article outlines the major provisions of the guidance and helps you learn how to make it work for your company.

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FDA Guidance on Responding to Unsolicited Requests for Off-Label Information

The Social Media Guidelines Nobody Expected!

Two days after Christmas, on December 27, 2011, while most of us were still on vacation, the FDA quietly issued "Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices." Section VI. of this guidance addresses responding to unsolicited requests on public forums such as the Internet. This article takes a closer look at how the off-label guidelines apply to social media such as Youtube, Blogs, and Twitter.

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FDA's Good Reprint Practices Guidance

Pros and Cons of the Proposed Rules for Distribution of Off-Label Information

Medical journals may soon become the pharmaceutical industry's newest physician marketing partner. On Friday, February 15, 2008, the FDA published its draft guidance on "Good Reprint Practices for the Distribution of Medical Journal Articles ... on Unapproved New Uses of Approved Drugs..."

This article summarizes some of issues raised by FDA's proposal that pundits and experts are debating on the Internet, in the press and in official comments submitted to the FDA. It also presents preliminary results of an online survey sponsored by Pharma Marketing News.

Topics and issues covered include:

  • Summary of FDA's Proposed "Good Reprint Practices"
  • Preliminary Survey Results
  • Role of American Enterprise Institute
  • Summary of Section 401 of FDAMA
  • Peer-Review

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FDA Opens Window for Pharma to Correct Misinformation Online

Wikipedia is at the Top of the List

This article reviews the FDA's guidance on how pharmaceutical companies can respond to misinformation related to a firm's own FDA-approved or -cleared products when that information is created or disseminated by independent third parties on the Internet or through social media, regardless of whether that misinformation appears on a firm's own forum or an independent third-party forum or website.

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FDA Publishes First Piece of Long-Awaited Social Media Guidance

Focus is on Accountability

On January 14, 2014, the FDA published "Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics" in the Federal Register (Docket No. FDA-2013-N-1430).

Although the guidance is focused on when and how pharma companies should submit forms to the FDA to fulfill regulatory requirements for postmarketing submissions, it does offer some insights regarding FDA's thinking on regulating "interactive media."

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FDA Sets Up a Roadblock for Branded Rx Promotional Tweets

Are There Any Useful Detours or Workarounds?

This article reviews the FDA's guidance on how pharma marketers must present both benefit and risk information within a "promotion" of FDA-regulated medical products via electronic/digital platforms that are associated with character space limitations: i.e., specifically through social media such as Twitter and through online paid search (e.g., "sponsored links" on search engines such as Google and Yahoo). The review also includes some ideas on how pharma marketers may be able to use Twitter for branded Rx messages and still be compliant with the new FDA guidelines.

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FDA Social Media Guidelines May Be Moot...

If This Court Decision Holds Up

Drugmakers dissatisfied with the FDA's use of guidances as a form of policymaking -- including long-awaited guidance for use of social media by the pharmaceutical industry -- could find legal ammunition against the practice. This article presents the relevant case information.

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FDA's Use of Social Media

Peanuts Today, Drugs Tomorrow!

n the future, will the FDA also be pulled into social media by a major Rx drug recall? What can the drug industry learn from the FDA's use of social media and will FDA's example help guide the industry toward best practices in this area? This article describes FDA's social networking initiatives in context of these questions.

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Focus on Drug Safety Communication & TV DTC Advertising

A Review of Two New FDA Guidance Documents

This article reviews two recently published and important guidances from the FDA that concern the dissemination of drug information to consumers.

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Free Gifts to Physicians: What's the Big Deal?

Pharma Marketing News hosted an online survey and a Pharma Marketing Expert Roundtable discussion on the topic of pharma gifts to physicians. This article summarizes the findings of that survey and includes comments and insights from survey respondents and Roundtable members.

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Free Drug Samples - The Sales Rep's Last Great Hope?

Should free drug samples be banned? The new PhRMA Code on Interactions with Healthcare Professionals bans free pens and out-of-office lunches, but it doesn't ban samples. Many sales consider free drug samples an important marketing tactic that they can employ to gain access to physicians. In 2005, the pharmaceutical industry distributed more than $18 billion worth of drug samples. But critics are concerned that drug samples increase costs, raise questions about the appropriateness of treatment choices, and create real or perceived conflicts of interest in the medical profession.

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The FTC-Lilly Consent Decree: What it Means for PHARMA Vendors and Partners

The 2002 settlement between ELi Lilly and the FTC regarding 'unauthorized disclosure of sensitive personal information collected from consumers' has an impact beyond Lilly. It also affects its agents who collect personally identifiable information from consumers in 'connection with the advertising, marketing, offering for sale, or sale of any pharmaceutical productÂ…' Such agents could include interactive agencies that build and maintain Web sites, direct marketing agencies, fulfillment centers, market researchers, etc. If you are a pharmaceutical service provider, read this commentary to learn what you need to do to be compliant with privacy and security standards demanded by your pharma clients.

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The Future of DTC Advertising

Is a Perfect Storm Brewing?

Experts don't know if it's the economy, lack of new drugs in pharma's pipeline, or the new pro-regulation political climate, but 2009 is shaping up to be the year that direct-to-consumer (DTC) advertising will suffer a round of budget cuts and setbacks not seen in a long time. We poll readers and experts to help predict the immediate future of DTC advertising and to get some insights from experts.

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Good Promotion Practices Alliance

Plenty of attention being paid to pharmaceutical marketing fraud and abuse cases in blogs and in the general media. But there hasn't been much attention paid to good compliance solutions or best practices. That's the mission of the Good Promotion Practices Alliance (GPP), which is co-sponsored by Reprints Desk and Prolifiq Software.

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Guidelines for Off-label Communications

Off-label information distribution by pharmaceutical companies to physicians is legal and in common practice, though 'off-label confusion' might be the better term. This article reviews several court cases relating to false claims associated with off-label communications and suggests seven steps to safely for marketing a pharmaceutical product for an unapproved indication.

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HealthPrize Teams Up with RealAge to Improve Adherence

High Engagement in Reward Program Among Asthma/COPD Patients

Unless taken, medicines don't work. Lack of medication adherence is a major issue contributing to poor health outcomes and higher costs. HealthPrize Technologies believes it has at least part of the solution, which is to provide an innovative approach with an online and mobile-based program that is fun, engaging and educational. This article summarizes the results of a six-month asthma and chronic obstructive pulmonary disease (COPD) pilot study in which HealthPrize partnered with RealAge to test patient engagement with the HealthPrize online and mobile platform.

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Here Come the Pharma Wikipedians

The Pros and Cons of Pharma Employees Editing Wikipedia Articles

Should pharmaceutical companies appoint employees as Wikipedia 'spokespeople' to perform all edits to Wikipedia articles on behalf of the company?

That is the opinion of Bertalan Meskó, MD, founder and managing director of Webicina.com, who, in a June 13, 2012, open letter to pharmaceutical companies, invited them to "employ a Wikipedia editor if you want to make sure only evidence-based information is included in entries about your own products."

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How Should Pharma Engage in Social Networks?

Thoughts on Best Practices

Each pharmaceutical company should have its own guidelines for best practices in the social media space. To assist in that discussion, Pharma Marketing News hosted a survey to explores issue relating to pharma advertising and engagement in social networks. This article summarizes the results of that survey.

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How to Host a Successful Pharma TweetChat

Tips from Boehringer Ingelheim

This article reviews BI's "playbook" -- titled "How pharma TweetChats can drive healthcare innovation" -- which provides detailed insights for planning and delivering successful pharma TweetChats. The authors of the playbook -- Patricia Alves, Social Media Community Manager, and Jaclyn Fonteyne, Social Media Specialist, at BI -- were also interviewed for this article.

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Industry and Consumer Advocates Square Off Regarding Social Media

This article presents an overview of the types of organizations that submitted comments versus those that made presentations at the November 2009 public hearing. It also includes general comments from the pharma industry regarding the process by which the FDA should regulate the Internet and social media. Also presented in this article are the comments submitted by consumer advocates and individuals who generally supported more strict regulation across the board.

Also see:

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Integrating Compliance into Commercial Practices

Pharmaceutical sales and marketing people often have an uneasy relationship with their compliance colleagues. In these days of OIG anti-kickback regulations and PhRMA guidelines for marketing to physicians, it behooves marketing professionals to work more cooperatively with compliance officials. In this article, two compliance officials from different pharmaceutical companies discuss ways in which commercial and compliance personnel can work together toward common goals.

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Is Pharma Ready for HIPAA?

Although most experts agree that pharmaceutical companies are not covered entities under HIPAA, this does not mean that pharma marketers should not worry about it. Pharma needs to realize that HIPAA will have a significant impact on the commercial side of their business. One effect, for example, will be HIPAA's influence on state medical privacy laws, which may directly affect pharmaceutical companies and their advertising and marketing partners.

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Let's Respond to FDA's Questions Regarding Its Regulation of Social Media

On Monday, September 21, 2009, the FDA published a notice in the Federal Register calling for a public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools.

The FDA is requesting the public to submit comments to a series of specific questions, which are included in a new survey created by Pharma Marketing Network/News. Let's use this survey to help educate the FDA on the issues.

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Limiting Bias in Commercially Supported CME

How Can Bias in Commercially-Sponsored CME Be Limited?

Many critics of pharma-supported CME believe this support leads to bias. Between 9 May 2011 and 13 September 2011, readers of Pharma Marketing News were asked to answer a few short questions relating to potential bias in industry-supported CME programs and how to limit the need for industry funding of CME. The results are summarized in this article.

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Managing Privacy Risks in Your Commercial Practices

Even though the privacy regulations under HIPAA (the Health Insurance Portability and Accountability Act of 1996) do not directly apply to pharmaceutical companies, HIPAA may have heightened health privacy sensitivities among consumers and health professionals. Learn what practical advice two attorneys at pharmaceutical companies have for their colleagues wishing to manage privacy risks.

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Medical Device Marketing: Worlds Apart from Rx Drug Marketing

Medical device marketing is different than Rx drug marketing, which is something attendees of the recent PharmaMed Marketing & Media Conference hosted by Med Ad News learned.

This article summarizes a presentation from that conference and discusses how medical device marketing to consumers and physicians is different than Rx drug marketing. While some device marketing campaigns take a page from the Rx arena, there are difficulties and roadblocks ahead and these are also summarized in this article.

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Mining Mobile Health App User Data

Liberating Health Data While Protecting Privacy

A conversation with Jacqueline Thong, co-founder and CEO of Ubiqi Health, about disease management mobile applications and how pharma marketers can leverage mobile health apps to engage with and learn from patients.

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Mobile Pharma Marketing: What's the 411?

Mobile devices -- especially cell phones -- are becoming ubiquitous in the U.S. How can pharmaceutical companies use this technology for consumer acquisition and retention? To get some ideas, we interviewed Robert Flynn, President of Pulse Media Response, LLC, and summarize that discussion in this article.

Topics and issues covered include:

  • Mobile Text Messaging
  • Shortcodes: Ubiquitous as URLs?
  • Immediate Response
  • Mobile Marketing for Customer Acquisition
  • Mobile Dialog for Compliance
  • Text Messaging Best Practices

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Mobile Regulatory Fears

PhRMA Raises an Alarm

In a blog post provocatively titled 'An App for That, But For How Much Longer?', PhRMA's Kate Connors agreed with a Washington Times op-ed piece that suggested the FDA will soon require apps such as medication prescription renewal reminders and blood glucose level tracking functions to be regulated as medical devices. The op-ed author, Joel White, executive director of the Health IT Now Coalition, suggests that this effort would lead to increased costs as well as constraints on user access to these apps, which 'may cause developers to move on to other, less burdensome endeavors.' 'In the end, this could hinder the way that patients can actively improve their own care,' said Conners. Is this fear warranted? Are there apps that SHOULD be regulated by the FDA? Read this article and find out.

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Most Credible Bad Ad Complaints are Submitted by Pharma

Why Now?

According to a Bad Ad Program 2010-2011 Year End Report just issued by the FDA, the program is a success despite the fact that ONLY 125 complaints were deemed worthy of "comprehensive review." The remaining 203 Bad Ad complaints were presumably filed away in DDMAC's circular file. Those 125 complaints worthy enough for review lead to 5 enforcement actions.

FDA received complaints from three sources: Healthcare Professionals (HCPs), Consumers, and "representatives of regulated industry" (ie, pharma companies ratting out their competitors). The "pharma" group of complaints was the most credible.

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Moving the Needle on Adherence

Both the financial and social implications of non-compliance were the subjects of the recent 7th Annual Forum on Patient Compliance, Adherence and Persistency. This article presents highlights and case studies from this forum..

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Murky Physician Marketing and Education Practices

This commentary takes a look at some "murky" (ie, non-transparent) physician marketing practices and presents opinions from several Pharma Marketing Blog polls and commentators.

Topics and issues covered include:

  • Physician Consultant Fees
  • The Case of Dr. Nissen
  • When is a Free Lunch More Than Just Lunch?
  • It's Access, Stupid!
  • Dumb Blonde Reps vs. Slovenly Genius Reps

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New Media Privacy Issues & Online Health Marketing

Privacy Groups Focus on the Pharmaceutical Industry

Recently, online privacy issues have been in the news as Congress exams whether it should enact legislation requiring a do-not-track function in Web browsers to allow consumers to opt out of the extensive data collection by Internet companies. This article is a summary of A Center for Digital Democracy complaint filed with the FTC and a review of the issues. The article also includes a compilation of more than two dozen 'innovative" online marketing products/solutions mentioned in the complaint.

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New Privacy Rules in Economic Stimulus Law

Will They Restrict Certain Pharmaceutical Marketing Practices?

This article reviews the medical privacy restrictions included in the American Recovery and Reinvestment Act, which President Obama signed into law on Feb. 17, 2009, and discusses the impact these restrictions might have on pharmaceutical marketing.

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The New Rules of Marketing & PR

Book Review and Insights for Pharma

The pharmaceutical industry must find ways to utilize the new media tools that other industries use while ensuring compliance with FDA regulations. The good news is we can! The author summaries the content of the book and offers practical guidelines for the pharma marketers.

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New Social Media Regulatory Framework

A Critical Analysis

Envision Solutions and TNS Media Intelligence/Cymfony teamed up to write a white paper, which summarized a new social media monitoring and marketing regulatory framework for pharmaceutical companies. This article takes a critical look at the Framework and offers further insights into the regulatory issues it raises.

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No More Free Lunch in California?

California legislature recently passed SB 1765 (aka, 'fair drug marketing bill'), which requires pharma companies to comply with PhRMA and OIG Guidelines. this article summarizes the provisions of this bill, which is currently awaiting signature by Governor Schwarzenegger.

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Overcoming Space Limitations in Social Media

This article presents a summary of comments to FDA from the drug industry addressing regulatory concerns when using social media tools associated with space limitations or tools that allow for real-time communications to present product information.

Also see:

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Peter Rost

Whistleblower, Pharma Blogger, ???

It might be fair to call former Pfizer marketing VP Peter Rost "Pharma's Black Knight" because of his confrontation with the drug industry over drug importation and his "whistle-blower" case against Pfizer. He achieved notoriety on 60 Minutes and in testimony before the US Senate regarding high US drug prices and drug importation from Canada by US citizens. Using these pulpits, Rost has criticized the drug industry on their stance against importation, calling it "fundamentally unethical." After his 60 Minutes interview, Pfizer temporarily cut off his phone and email service and eventually fired him.

This article is based on an interview in which Rost describes his new post-Pfizer vocation: Blogger!

Topics covered include:

  • Peter Rost the Whistle Blower
  • Peter Rost the Blogger
  • A Unique Style
  • Pharmacia and Genotrophin
  • The Andy Rooney of Pharma Bloggers
  • Peter Rost on Medicare Part D
  • Peter Rost on Trustworthiness of Drug Industry
  • A Sampling of Rost Blog Posts
  • What Does Rost Plan To Do For Money These Days?

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Pfizer's Short-lived LIPITOR Branded Mobile App

Was It a "Bad Ad" or Just a Bad Idea?

On May 22, 2012, Pfizer and Eating Well Media Group, publisher of Eating Well magazine, announced the launch of Pfizer's Lipitor For You "Recipes 2 Go" mobile application, marking the first time Pfizer has released a consumer mobile app for a prescription product in the U.S. Was It a 'Bad Ad' or Just a Bad Idea?

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Pfizer Throws In the Lipitor Marketing Towel

Meanwhile AstraZeneca Promotes Crestor on Its Corporate Blog

Despite Pfizer's heroic and unprecedented effort to maintain Lipitor's market share after expiry last November and after spending more than $87 million promoting the medicine, the world's biggest drug company is quietly giving up on its once-great cash cow for good because more generic versions will soon be going on sale. Meanwhile, AstraZeneca promoted Crestor on its corporate blog. It's unusual for a pharmaceutical company to mention a product by brand name on its corporate blog. It's even more unusual to mention BOTH the product AND its indication -- because that would be promotion regulated by the FDA. But AstraZeneca has done just that on its 'AZ Health Connections' corporate blog. Why now? Can it be a purely opportunistic cheap shot?

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Pharma Begins to Reveal Payments to Physicians

Analyzing the Numbers and Spreading the Sunshine

This article reviews the physician payment lists published by Lilly, Merck, and GSK. The analysis gives us more insight into the fees paid by various companies, how the money was distributed by state and region in the US, and what types of activities (eg, speaker fees vs. consulting fees) physicians were paid to perform.

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Pharma Finds Little to Like in Recent FDA Social Media Guidance

Delete, Limit, & Clarify Says Industry

The comments are in! As usual, the pharma industry waited until the last minute to submit comments to FDA Docket 2013-N-1430 regarding "Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics."

This article provides highlights from submissions by Novartis, Shire, the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the country's leading pharmaceutical research and biotechnology companies, the Biotechnology Industry Organization (BIO), Klick Health, the Social Media Compliance Council (SMCC), the Coalition for Healthcare Communication (CHC), and the Digital Health Coalition (DHC), and other interested parties.

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A Pharma Social Media Conspiracy Theory

Were Guidelines Held Hostage as Part if FDA's and DOJ's Criminal Investigation of Google?

Were FDA's infamous 14 warning letters to pharma a ploy to force Google into a $500M DOJ settlement regarding illegal online pharmacy ads? In addition, could FDA have been holding back issuing pharma social media guidelines -- which would include guidelines for displayig compliant information in space-limited applications such as Twitter AND Google Adwords -- until Google settled its case with the DOJ?

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Pharmaceutical Marketing in Texas: look out for state privacy laws!

This article provides an update on medical privacy legislation in Texas and its effect on pharma marketing in that state. Included is an analysis of bill SB 330 and SB 1136, which were signed into law in the Spring of 2003, These laws will have an impact on the ability of pharmaceutical companies to market their products in Texas.

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Pharma Responds to FDA's Draft DTC Guidelines

PhRMA, Sanofi, Shire, and Others Submit Comments to Docket

FDA has received several comments from the pharmaceutical industry regarding the agency's 'Draft Guidance for Industry Direct-to-Consumer Television Advertisements.' This article reviews the comments submitted by PhRMA, Sanofi, and Shire. Comments from other pharma companies addressed similar issues to the ones reviewed here.

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Pharma-Sponsored Medical Ghostwriting: What the Ghosts Have to Say About It

Pharma Marketing News surveyed readers to determine if medical journal articles sponsored and ghostwritten by drug companies are a legitimate part of marketing to physicians and to get opinions on various other issues raised in the press about ghostwriting.

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Pharma's Image Conundrum

Building Brand Loyalty and Consumer Confidence

In this guest article, Carla Stratfold, CEO at OnRequest Images, presents several key learnings and best practices that pharmas can follow when building brand and consumer loyalty.

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Pharma's Black Knight Confesses All!

A review of the book THE WHISTLEBLOWER: Confessions of a Healthcare Hitman.

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Pharma's Social Media Working Group

Who It Consists of, How It Formed, and Its Role in Driving FDA Guidance

This article reviews the Who, What, and Why of Pharma's Social Media Working Group (SMWG) based on a conversation with Mark Gaydos, Senior Director, U.S. Regulatory Affairs Marketed Products at sanofi-aventis, and Cynthia Phillips, Sr Dir Labeling and Promotional Compliance at Millennium Pharmaceuticals. Also covered is an analysis of comments the SMWG submitted to the FDA on how pharmaceutical companies should handle off-label and adverse event posts made on social media sites owned or sponsored by them.

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Pharma's Plodding Approach to eMarketing

Mind-Boggling Communications Vs. Mind-Numbing Resistance

This article, written by health communications veteran, Harry Sweeney, is a frank assessment of the pharmaceutical industy's plodding approach to e-communication and e-marketing based on a review of a recent industry conference.

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Pharma's Social Media Marketing Readiness Score

Benchmarks You Can Use

This article summarizes the aggregate findings of the Rate Your Social Media Marketing Readiness survey and presents the average scores against which you can compare your own score.

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The Pharmaguy Social Media Timeline™

TVolume 2: June 14, 2011 through January 31, 2014

Since June, 2011, when Pharmaguy published the first iteration (Volume One) of the Timeline there have been many noteworthy pharma social media events, trials, and tribulations that deserve to be added to the Timeline. Volume Two includes 23 new items/events from June, 2011 through January, 2014

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The Pharmaguy Social Media Timeline™

Volume 1: A Record of Social Media Events Impacting the Pharmaceutical Industry

The long-awaited social media guidance from the FDA -- whenever it arrives -- may turn out to be nothing more than a stamp of approval on activities in which the industry is currently engaged. Practically every issue that FDA guidance is expected to address has already been handled independently by a few pioneering pharmaceutical companies. Rather than waiting for FDA's anti climatic guidelines, Pharmaguy decided to publish The Pharmaguy Social Media Timeline™ now, at a time when the industry already has set precedents in every social media application.

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PhRMA Code Succeeding -- So Far

This article summarizes the views of Scott Willoughby, Senior Manager of Ernst & Young and former Assistant General Counsel to the Pharmaceutical Research and Manufacturers of American (PhRMA) with regard to the current state of compliance with the PhRMA Code on Interactions with Healthcare Professionals and how it is impacting sales effectiveness.

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PhRMA's Code on Interactions with Healthcare Professionals

To better understand the impact on the pharmaceutical industry of PhRMA's Code on Interactions with Healthcare Professionals, Pharma Marketing News surveyed readers between July 10, 2008 and August 7, 2008, and collected comments from pharma-focused blogs and bulletin boards. This article is a summary of the PMN survey results and opinions of experts, bloggers, and anonymous commentators.

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Politics Vs. Science in the Plan B Decision

Was Sebelius Politically or Scientifically Correct to Block Broader Plan B Availability?

Sebelius focused on the fact that Teva's study did not contain data for all ages for which this product would be available for use. According to Tina Raine-Bennett, MD, MPH, of the Women's Health Research Institute at Kaiser Permanente Northern California, a principal investigator of the University of California-San Francisco study, it is unreasonable and virtually impossible to study the use of emergency contraception in 11- and 12-year-olds, because only a small fraction of them will have had sex by that age.

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Predicting the Future of the Drug Industry

What's in Store for the Next Decade?

Every new year we either take a look back or ahead one year. Many people would rather forget about 2009 and look forward to better times in 2010. But what about looking even farther into the future? Since we just finished the first decade of the 21st century, why not look into our crystal balls to predict what the next decade (2010-2019) holds in store for the pharmaceutical industry.

This article reviews the results of the 'Predicting the Future of the Drug Industry: 2010 & Beyond!' survey and provides background on future trends.

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Print DTC: How Does It Measure Up?

Over 60 drug ads that appeared in several major consumer magazines were analyzed. In each, the space allocated to images, benefit statements, risk information, and the brief summary was measured. This article summarizes the findings.

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Proposed Rules for Physician Payment Sunshine Act

Looming Challenges Cloud Implementation

This article reviews the strategic implications of the Sunshine Act and also presents highlights of the draft regulations rule released by the Centers for Medicare and Medicaid Services on December 15, 2011.

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Protecting Your Brand with Anti-Counterfeiting Solutions

This article reviews Cardinal Health's portfolio of brand security technologies.

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Ramifications of FDA Regulatory Actions

Helping FDA Find a New Media Regulatory Pathway

Arnold Friede, counsel to the law firm McDermott Will & Emery LLP, and former Senior Counsel at Pfizer, believes that there is an opportunity now to make a strong and compelling argument for the adoption of rational regulatory policies by the FDA that address the unique features not only of sponsored links, but of other kinds of new communication tools, such as social media.

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Real Patient Testimonials

This article discusses the potential pitfalls, regulatory issues, and best practices regarding the use of real patient testimonials based on comments collected from a recent survey of readers and other experts.

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Reforming the FDA: It All Starts with a New Commissioner!

Possibly the most important political change facing the pharmaceutical industry in 2006 is who will be the new FDA Commissioner. Various stakeholders -- including executives and staffers working within the pharmaceutical industry, agents and vendors to the industry, healthcare professionals, members of the general public, and staffers within government health agencies -- have divergent opinions on who should be the commissioner and why. This article summarizes the results of a recent survey of such stakeholders.

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Report from the Social Pharmer "Unconference"

Sowing Seeds of Social Media Change?

This article summarizes key presentations made at the April 21, 2009, Social Pharmer 'unconference' where leading pahram social media proponents presnted ideas on how the industry can overcome the barriers.

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Reporting Gifts to Physicians

Massachusetts and several other states have put either banned all gifts to physicians by pharmaceutical companies, placed limits on gifts, or or considering doing so. At least 'sunshine' acts have been proposed in Congress as well. This article reviews some aspects of these 'sunshine' laws and focuses on a recent CALPIRG analysis of drug company gifts to physicians.

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Responding to the Challenges of Evolving Regulation

A point-counterpoint assessment of ACCME's draft Standards for Commercial Support (SCS), OIG guidance and the effect on the partnership between accredited CME providers and pharmaceutical supporters.

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Right & Wrong Ways for Pharma to Correct Misinformation on Wikipedia

Some Guidelines for Pharma

In a recent report, the IMS Institute for Healthcare Informatics noted that Wikipedia articles on health issues are "in flux" and that there is a need for "knowledgeable editors" to keep the information as current and unbiased as possible.

Should the pharmaceutical industry or agents of the industry step up and edit content on Wikipedia?

This article discusses both the right and wrongs ways for pharma to do this using real-life examples.

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Risk Mitigation and Its Impact on Pharma Marketing

Appropriate Use Benefits After Launch

Risk management, REMS, danger management of your product's life cycle, whatever you call it, all are crucial to brand managers and marketing executives. In this article, Jeff Fetterman, President and CEO of ParagonRx, summarizes his ideas about how to develop a REMS that can be a win-win-win situation for you, your product, and the patient.

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The Scientific Path to Corporate Leadership

Three pharmaceutical company CEOs discuss their path from science to leadership and the role of medical science liaisons.

Topics and issues covered include:

  • The Seven Fundamental Elements of OIG Compliance
  • Handling Unsolicited Requests from Physicians
  • The Relationship between R&D and the MSL Team
  • Science and Corporate Leadership
  • Classic Sales Rep: An Endangered Species?
  • Case Study: Laurence J. Downey
  • Ernest Mario, a Horatio Algier Story

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Search Advertising Options for Pharma

In this article, Julie Batten, eMarketing Manager at Klick Pharma discusses pharma's options for search marketing in this period between the FDA public hearing and when the much anticipated draft and final guidance on the issue is published.

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Social Communications in Healthcare: Summary of Roundtable Discussions

At the Social Communications in Healthcare conference hosted by the Business Development Institute in NYC on July 23, 2009, there were so many people live Tweeting the case study presentations that it's hardly worth the effort to summarize these presentations after the fact. You can find a good summary--if only in dozens of 140-character packets--on Twitter.

An excellent gauge of the state of social communications in healthcare may be had from summaries of the round table discussions moderated by experts after the case study presentations. After a short introduction, this article provides several summaries written by the roundtable discussion leaders themselves

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Social Media Adverse Event Reporting Safe Harbors

This article presents ideas for regulatory 'safe harbors' under which pharmaceutical companies would be relieved of the responsibility of monitoring social media for adverse events. Includes a detailed summary of responses to the survey 'FDA Regulation of Drug & Device Promotion via the Internet & Social Media' regarding social media adverse event monitoring, processing, challenges, and uncertainties.

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Social Media, Latent Spokespersons & Native Advertising

Questions Raised by FDA Guidelines with Answers, Sort Of

FDA's "Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics" has left many questions unanswered.

Proving deep interest in the topic, more than 400 people attended the "Green light or go slow: What FDA's new draft guidance means for social media in pharma" webcast on March 13, 2014 during which over 40 questions were asked.

This article focuses on a few of the issues, gray areas, and questions mentioned during this webcast and also in comments submitted to the FDA.

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Solving the Social Media Adverse Event Reporting Problem

Many presenters at FDA's November 2009 public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools addressed this problem and offered solutions. Comments submitted to the FDA after the meeting offer more details, which are reviewed in this article.

Also see:

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Some Unregulated Physician Smartphone Apps May Be Buggy

Especially "Calculator" Apps Like These...

Practically every pharmaceutical company has one or more apps. The ones I am interested in are apps designed to help doctors in their diagnosis of patients. Big among these are the "calculator" apps, which calculate things such as glomerular filtration rate (GFR), Medication Adherence Rating Scale (MARS), Delayed Graft Function (DGF) Risk, creatinine clearance, dosing algorithms, Body Mass Index (BMI), and, my favorite, Psoriasis Area and Severity Index (PASI). At least one of these apps has been recalled due to a software bug. But recalling does not mean it's not still being used by physicians.

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Strategies for Marketing Compliance

All pharma companies face a communications crisis that rests on the changing role of the medical sales representative. This evolution has a direct impact on the obligations of the pharma marketing organizations to be both proactive and responsive in helping to protect their organizations from the threat of non-compliance.

What can marketing do? This article offers a few thoughts from a physician's point of view, written by Jonathan Sackier, M.B., Ch.B., FRCS, FACS who is a regular blogger at www.goodpromotionalpractices.com.

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Supporting Patients via Twitter and Beyond

Boehringer Ingelheim Shows How It's Done

Although nearly two-thirds of respondents to a 2009/2010 Pharma Marketing News survey thought that using Twitter for patient support activities would be somewhat or very effective, relatively few pharmaceutical companies are doing this on a regular basis. From time to time, however, it does happen.

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Time for a New & Improved FDA Commissioner

OpEd by John Mack

There is no doubt that Dr. Andrew von Eschenbach, the current FDA Commissioner, will soon be leaving the FDA and will not allow the door to hit him on the ass on the way out.

Who will Obama nominate to replace von Eschenbach? There are plenty of special interest groups that would like to influence his decision.

I wonder how Obama will balance all these diverse interests to pick the right person? Whoever the nominee is, the new FDA Commissioner will also need to balance competing interests.

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Trends in Commercial Support of CME

Separate But Aligned with Marketing

More than ever, it is important to educate physicians about new drugs and to keep this education separate from the marketing function of the company yet aligned with commercial goals.

Members and guests of the Pharma Marketing Roundtable met via conference call to discuss trends in commercial support of CME. This article summarizes that discussion.

Topics covered include:

  • Will commercial (for-profit) CME providers and producers increasingly give way to academic center networks? Are the days of the large CME companies numbered?
  • Which technological and media approaches for CME delivery are gaining favor...and which are losing ground?
  • What role should CME play in strengthening the communicative skills of MDs in their interactions with patients? Why aren't we seeing more of this with the advent (peaks and valleys) of DTC?
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The Truth About the Drug Companies: What To Do About It

You can't go to a pharma industry conference these days without hearing at least one expert speaker recommending that pharma executives read the book "The Truth About the Drug Companies: How They Deceive Us and What to do About It," written by Marcia Angell, MD, former editor in chief of The New England Journal of Medicine. It's not often that you see pro-industry pundits recommend a book that "tears pharma a new one," as some would say. This review includes several point-counter point views regarding Angell's arguments by pharmaceutical and healthcare experts, including members of the PHARMA-MKTING online discussion group.

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The Twelve Steps of Pharma Social Marketers Anonymous

Welcome to Pharma Social Marketers Anonymous (PSMA)! You are among friends. Soon, you will take important steps on the path to overcoming your fear of social media. The first step is to admit you are powerless over social media and that your online life has become unmanageable. Are you ready to take ALL 12 steps toward recovery?

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US Drug Shortage & Supply Chain Crisis

Pharma's Missed Opportunity to Support Patients via Social Media

Although many pharmaceutical companies actively use Twitter and other social media tools to push out positive news about their companies and products, very few use these tools for systematic support of patients who depend upon their drugs, which may be short supply.

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Use of Behavioral Targeting by Pharma Marketers

When Is It Appropriate?

This article summarizes the results of a survey designed to answer the questions: Should the pharmaceutical industry adopt similar self-regulatory principles that were established by media and marketing trade associations to protect consumer privacy when employing behavioral targeting, Should pharma marketers use behavioral targeting at all?, If they do use it, when is it appropriate?

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Use of Celebrities for PR and DTC Advertising

"Break a Leg," But Avoid Pratfalls!

If you have questions about the 'dos & don'ts' and 'pros & cons' of using medical and non-medical mouthpieces for pharma PR and DTC advertising, this article provides some answers and opinions based on interviews of experts with years of experience in this area.

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Use of Twitter for Patient Support

Should Pharma Fill the HCP-to-Patient Social Media Vacuum?

Twitter has often been hyped as a great way to support customers. The customers of pharma are physicians and patients. But pharma Twitter accounts offer very little in terms of patient support. This article summarizes a survey that asked respondents to evaluate several ways in which Twitter could be used to improve patient support.

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Value-based Pricing

This article summarizes the second half of a presentation by Uday Bose, European marketing director for GlaxoSmithKline Oncology, in which he focuses on reform attempts within European countries and pharma's reactions, the benefits and perils of risk-sharing agreements and how pharma might best meet the challenges of the marketplace now and into the future.

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Vast Majority of Drug Ads in Leading Medical Journals Don't Pass MDs' Sniff Test!

Over Half Failed to Quantify Serious Risks, Including Death

A study led by Mount Sinai School of Medicine researchers of 192 pharmaceutical advertisements (83 full unique advertisements) in biomedical journals found that only 18 percent (15) were compliant with Food and Drug Administration (FDA) guidelines, and over half failed to quantify serious risks including death.

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The View From ePharma Summit: Practicing What Was Being Preached!

This article is a compilation of summaries of presentations made at the 2009 ePharma Summit. Included are highlights posted to the ePharma Summit and other blogs during the conference and insights on epharma marketing issues provided by several conference speakers and attendees.

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Web 2.0 Pharma Marketing Tricks for Dummies

Pharmaceutical marketers are having a field day pushing the envelope on the Internet and especially in the social networking, Web 2.0 arena -- the new WILD, WILD WEST of the Internet. Many, however, are getting caught trying to perform the 'tricks of the trade.' With just a little bit of guidance and tips from the masters, you can perform these tricks WITHOUT getting caught!

Topics and issues covered include:

  • Consumer-Generated Content - some data
  • Why Neither the FDA nor PhRMA Will Be the Wiser
  • HealthTrain, the Open Healthcare Manifesto
  • The So-called "One-Click Rule"

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What If There Were No Rules in Pharma Marketing?

Be Sure Not to Cut Off the Ends of Your Ham

What If There Were No Rules in Pharma Marketing? There's no FDA, no DDMAC, no FTC. Your company guidelines and rules don't exist and your regulatory and legal teams have been disbanded. It's a free-for-all and there are no rules. The question is: what would you do?

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What Pharma Companies Spend on Gifts to Docs

At least nine states are considering bills that would require pharmaceutical companies to publicly report annual gifts to physicians, hospitals and pharmacists with California and Vermont in the lead. This report provides numbers of spending limits and average spending by major phramaceutical companies on gifts to physicians in California. Excepts from company compliance statements are also presented to give readers an idea of how pharma companies interpret the sometimes ambiguous or conflicting requirements of different states and voluntary guidelines established by PhRMA and OIG.

Topics covered include:

  • Vermont Law
  • What is exempt from disclosure?
  • Non-prescribing Office Staff Also Covered
  • Pharma Compliance with Reporting Requirements (Bristol-Myers Squibb, Pfizer, Novartis, AstraZeneca, Procter & Gamble Pharmaceuticals, Organon, Centocor)
  • TABLE: Average and Median Annual Spending for 83 Pharma Companies

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What You Need to Know About the "CAN-SPAM" Law

Although the CAN-SPAM law is often portrayed as a white knight that will save us from dastardly e-mail spammers and pornographers, many of its provisions cover all commercial e-mail, even permission-based, opt-in e-mail. It is also applicable to B2B e-mail communications and one-to-one commercial e-mail messages such as e-mail from sales representatives to physicians.

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When Is Commercial Support Appropriate for CME Activities?

On April 1, 2004, the Board of Directors of the Accreditation Council for Continuing Medical Education (ACCME), by unanimous vote, adopted the updated ACCME Standards for Commercial Support of Continuing Medical Education. This article summarizes when it is and is not appropriate for pharmaceutical companies to support independent CME programs.

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Whose Data Is It Anyway?

Pharma Marketing News hosted the Pharma Use of Rx Data Survey in June, 2006 and asked respondents to weigh in on several issues regarding the collection and use of Rx data by pharmaceutical companies.

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Wither CME?

Congress continues to examine pharma industry support of CME and ACCME has issued some new guidance for accredited CME providers. This article examines the current state of industry support for CME and what reforms may be coming down the pike

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The Year 2013 in Images

Pharmaguy's Favorites from Pharma Marketing Blog

Every year Pharmaguy reviews the images that appeared on Pharma Marketing Blog and picks his favorites. After all, a picture is worth a thousand words! But rather than just presenting images out of context, Pharmaguy presents the images WITH context and comments, plus links, should you care to delve deeper.

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Pharma Marketing News is the periodic electronic newsletter of the Pharma Marketing Network (www.pharma-mkting.com). Pharma Marketing Network is an exclusive marketing information resource and communications network for pharmaceutical marketing professionals.

Each issue of Pharma Marketing News is packed with facts, opinions, and case studies based upon interviews with experts in the field of pharmaceutical marketing. Highlights of presentations from industry conferences and links to references help subscribers keep up to date on best practices and network with their peers.

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