Compliance with Regulations & Industry Guidelines
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.
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Also see:
- Industry and Consumer Advocates Square Off Regarding Social Media
- Overcoming Space Limitations in Social Media
- Solving the Social Media Adverse Event Reporting Problem
- Special Report: FDA’s Regulation of Drug & Device Promotion via the Internet & Social Media
A Few Things I Learned at FDA’s Social Media Hearing
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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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.
Click Here for Full Text – FREE! (pdf).
The Changing Policy LandscapeThe two traditional means by which pharmaceutical marketers have relied on for many, many years to encourage the uptake of newpharmaceutical 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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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.
Full Text Available (pdf) (FREE!).
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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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’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
- Includes comments from Pharma Marketing Roundtable members
Read this article now. It’s FREE… Click Here to Download Full text (PDF file)
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 product ’ 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.
Click Here for Full Text – FREE! (pdf).
Guidelines for Off-label CommunicationsOff-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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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.
Click Here for Full Text – FREE! (pdf).
Also see:
- Overcoming Space Limitations in Social Media
- Accountability for Pharma Content on Social Media Sites
- Solving the Social Media Adverse Event Reporting Problem
- Special Report: FDA’s Regulation of Drug & Device Promotion via the Internet & Social Media
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.
Click Here for Full Text – FREE! (pdf).
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.
Click Here for Full Text – FREE! (pdf).
Let’s Respond to FDA’s Questions Regarding Its Regulation of Social MediaOn 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.
Click Here for Full Text – FREE! (pdf).
Managing Privacy Risks in Your Commercial PracticesEven 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.
Click Here for Full Text – FREE! (pdf).
Medical Device Marketing: Worlds Apart from Rx Drug MarketingMedical 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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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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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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The New Rules of Marketing & PR
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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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.
Click Here for Full Text – FREE! (pdf).
Overcoming Space Limitations in Social MediaThis 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.
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Also see:
- Industry and Consumer Advocates Square Off Regarding Social Media
- Accountability for Pharma Content on Social Media Sites
- Solving the Social Media Adverse Event Reporting Problem
- Special Report: FDA’s Regulation of Drug & Device Promotion via the Internet & Social Media
Pharma Begins to Reveal Payments to Physicians
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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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.
Click Here for Full Text – FREE! (pdf).
Pharma-Sponsored Medical Ghostwriting: What the Ghosts Have to Say About ItPharma 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
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.
Click Here for Full Text – FREE! (pdf).
Pharma’s Social Media Marketing Readiness ScoreThis 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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Pharma’s Social Media Working Group
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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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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Download PDF filePhRMA’s New 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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Predicting the Future of the Drug 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.
Click Here for Full Text – FREE! (pdf).
Real Patient TestimonialsThis 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.
Click Here for Full Text – FREE! (pdf).
Reporting Gifts to PhysiciansMassachusetts 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.
Click Here for Full Text – FREE! (pdf).
Risk Mitigation and Its Impact on Pharma MarketingRisk 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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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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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
Click Here for Full Text – FREE! (pdf).
Social Media Adverse Event Reporting Safe HarborsThis 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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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.
Click Here for Full Text – FREE! (pdf).
Also see:
- Industry and Consumer Advocates Square Off Regarding Social Media
- Overcoming Space Limitations in Social Media
- Accountability for Pharma Content on Social Media Sites
- Special Report: FDA’s Regulation of Drug & Device Promotion via the Internet & Social Media
Trends in Commercial Support of CME
This article is an edited transcript of the June 2006, Pharma Marketing Roundtable discussion, which was devoted to trends in commercial support of CME.
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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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Use of Behavioral Targeting by Pharma Marketers
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
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
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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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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Download PDF fileWhat 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.
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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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Download PDF fileWhen 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.
Click Here for Full Text – FREE! (pdf).
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.
Click Here for Full Text – FREE! (pdf).
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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