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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.

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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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FDA Draft Guidance for Print DTCA: Less than Feared

On February 4, 2004, the FDA issued long-awaited draft guidance documents designed to improve communications to consumers and health care practitioners about health conditions and medical products.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

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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.

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

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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 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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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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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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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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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 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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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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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 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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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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