Curious about the implications of the new vlog for pharmaceutical marketing, I did a little digging to learn more about the vlog and the company producing it. My conclusion: Don’t look to Quigley Corporation’s vlog as an indicator of how pharmaceutical companies are going to handle the legal/regulatory issues relating to product promotion via vlogs, blogs and other social media. Three Reasons Why The PainGoes Vlog Is No Bellwether
- Reason I: Quigley Pharma Does Not Produce OTC Products: The title of Rubel’s post indicates that Quigley Pharma launched the vlog. This is not the case. Quigley Pharma is a division of Quigley Corporation that is focused on introducing “a line of naturally derived patented prescription drugs.” According to its Website, it is currently developing a number of prescription medications for the treatment of arthritis, the flu, diabetic neuropathy and other conditions. The company plans to submit these products to the Food and Drug Administration (FDA) for approval once they are sufficiently developed.
In addition, Quigley Corporation’s press release on the new vlog says that PainGoes is “completely independent of Quigley Pharma’s proposed RX formulations currently under development.”
Conclusion: Quigley Pharma is not sponsoring the vlog.
- Reason II: The FDA Does Not Regulate Most OTC Advertising: In his post, Rubel mentions that one reason Quigley may not have enabled comments on the vlog is because “of [FDA] restrictions regarding adverse events.” While this is certainly true for prescription medications, many OTC products fall under a different regulatory framework.
The FDA mandates that pharmaceutical companies report all adverse events to the agency. However, OTC products are different. Reports are only required for medications marketed under an approved New Drug Application (NDA). PainGoes does not fall under this category. In fact, the Quigley Corp press release states that the company makes no “claim that the potential medication discussed herein is safe, effective or approved by the Food and Drug Administration.” No NDA, no FDA regulation of OTC promotional activities.
In fact, the Federal Trade Commission has authority over OTC medical advertising. Currently, there is no requirement that companies report adverse events to the agency. However a bill was recently introduced, S.3564 (Dietary Supplement and Non-Prescription Drug Consumer Protection Act), that would make it mandatory for OTC manufacturers to report side effects.
This does not mean that Quigley isn't concerned about adverse events. However, side effects are less of a barrier to entry into social media for OTC drug makers than for prescription medication manufacturers.
Conclusion: Fear of adverse events is less of a problem for OTC makers; Regulatory lessons learned from Quigley’s entry into the vlogosphere may be of limited relevance to pharmaceutical companies.
- Reason III: Strategy, Not Fear Reason Quigley Has Not Enabled Comments To Its Vlog: According to Quigley’s press release, the company launched the vlog to help it test market PainGoes. It said: “The era of Vlogs is upon us and this new media vehicle allows us to test market PainGoes with minimal expense . . . this is a totally new approach to conventional advertising and we are hopeful that [others] will join with us in this endeavor to reach people online.” [Emphasis mine].
Quigley’s statement suggests that the company views the vlog as a one-way communications vehicle. They are simply testing a new advertising strategy, not attempting to engage in conversation with customers. A spokesperson for the company, who asked not to be identified, told me Quigley wants to test whether the vlog drives people to the PainGoes product Website and encourages them to purchase the product.
At this point Quigley has little to fear from adverse events. Very few people have tried the PainGoes. And, if an adverse event report came through via the vlog, it would decide whether to report it to the FTC. The side effect reporting process is voluntary. My guess is that they probably would.
Conclusion: Quigley Corporation has disabled comments because it views the vlog as a one-way communications medium, not a tool for conversation with customers. (At least for now.)
Rubel and I agree that pharma is fearful of the blogosphere. Clearly, there are many, many regulatory hurdles for drug companies to overcome before they launch social media communications vehicles. However, I would caution him from applying lessons learned from the Quigley Corporation experience to Big Pharma. Quigley is operating in a very different legal, regulatory, corporate and market climate.
When a company like Pfizer or GlaxoSmithKline launches a blog or vlog for a prescription medication, that’s when I’ll know the landscape is truly changing. From Rubel’s post it looks like he is trying to get pharmaceutical companies to understand how to do just that. I hope he is successful.
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