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:
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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.
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.
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.
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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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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."
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.
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.
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?
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.
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"
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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..
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.
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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.
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.
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.
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.
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.
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.
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!
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.
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?
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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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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.
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.
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?
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?
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.
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.
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.
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.
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.
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!
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?
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.
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.
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.
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.
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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Case Studies and Reviews featuring innovative Products and Services for Pharmaceutical Marketing and Sales. Presents Practical Solutions from leading vendors and suppliers.
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