FocusBranding, FDA Regulations, Viral Video, PhRMA Code
OpEdWill the Drug Industry be the Next Auto Industry?
Is the drug industry right on the cusp of a huge fall like the auto industry? Taking risks may hasten that fall, but sometimes standing on the sidelines may be more risky!
Planned Articles- Protection from Brand Infection
Marketers Must Take Control of Their Brands,
Especially Online
“Make no mistake,” says the Chief Marketing Officer (CMO) Council in the opening statement to its report Marketer’s Fight Against Fakes, Frauds, and Infringements, “marketers and their brands are under siege. A vast and ever-expanding range of threats to brand value, integrity and image are bearing down on marketers in the form of counterfeits, gray market knock-offs, phishing attacks, cybersquatting, and a broad range of patent and trademark trespassing, especially online—that will likely intensify thanks to a softening economy.”
In response to concerns about the growing range of threats to brand value and the sheer volume of brand hijacking incidents, the CMO Council set out to assess the challenges marketers face as stewards of their brands. The result is Protection from Brand Infection, a seminal authority leadership report that outlines the proliferating threat-scape that marketers face and reveals how marketers are struggling to understand and measure the impact brand intrusions have on their second most valuable asset, their customer.
This article summarizes the results of that survey and cites examples of how pharmaceutical brands are being hijacked and what the drug companies are doing or not doing to counteract the problem, especially online and in social media contexts.
- Ramifications of FDA Regulatory Actions and What to Do About It
Helping FDA Find a New Media Regulatory Pathway
On April 2, 2009, the FDA issued 14 letters informing drug companies that their search engine ads, which included drug brand names and indications but no risk information or fair balance, were in violation of the law. This caught many in the drug industry by surprise because they assumed the "one-click rule" applies; ie, as long as the fair balance information was just one click away -- on another Web page -- such ads are allowed by the FDA. With the 14 letters, FDA disagreed and quashed the "one-click rule."
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 and the like.
This article reviews legal ramifications of FDA enforcement letters and focuses on the FDA’s contentious regulation of Internet advertising and what the industry is doing to “help” it find a new path in that arena. Included is a discussion of FDA's draft guidance "Presenting Risk Information in Prescription Drug and Medical Device Promotion" and the relevance of FDA's/FTC's "reasonable consumer standard" to search engine paid promotional drug ads.
- The New PhRMA Code and Beyond
It Impacts Manufacturers and Vendors
In a recent ExL Pharma conference industry leaders from pharma and the vendor community reviewed the impact on “Marketing and Sales Under the Revised PhRMA Code”. In this article, Vincent DeChellis of NHHS Healthcare Consulting, LLC summarizes what the industry must do to comply with the code and reconciling its voluntary nature with mandatory state requirements.
- Kevin Nalty, aka "Nalts"
Viral Video Genius or Pharma's Biggest Pain in the Butt?
One man’s experience that gives us some insight into whether or not a traditional pharmaceutical company can tolerate the creative thinking required for it to engage in social media marketing.
Anticipated Publication Date28-May-2009
Ad Submission Deadline Date27-May-2009
ContactJohn Mack * johnmack@virsci.com * 215-504-4164
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