Earlier this month GlaxoSmithKline (GSK) launched a blog, alliconnect, that supports its marketing efforts for its new Food and Drug Administration (FDA) approved over the counter (OTC) weight loss drug, Alli (pronounced ally). It has received attention in and out of the blogosphere, because it as one of the first "branded" pharma-sponsored blogs.
In addition, the blog was a major topic during a social media virtual workshop I hosted earlier this week (click here to learn more and enroll). Some of the workshop participants were wondering how the FDA regulates OTC products and what GSK's efforts mean for social media marketing. Addressing this issue will tell us how many lessons we can apply from GlaxoSmithKline’s social media experiment to traditional prescription drug marketing.
How The FDA Regulates OTC Products
There are more than 100,000 products available to consumers without a prescription in the US. In order to be approved by the FDA, OTC products must have a wider margin of safety than prescription medications. This means these drugs have lots of data from clinical trials establishing their safety and efficacy. In contrast, many prescription medications are studied in very controlled, limited experiments before being approved for marketing.
Because OTC medicines are viewed as very safe by the FDA companies marketing them have more leeway in how they describe side effects and talk about their efficacy. For example:
-Drug Labels Are Not As Detailed: According to the law, OTC medication labeling must include “all of the information that an ordinary consumer needs for the safe and effective use of the product.” OTC labels are called “Drug Facts.” They contain substantially less information than a prescription drug label (click here for a Drug Facts label and here for a patient package insert).
-FDA Does Not Oversee OTC Drug Advertising/Promotion: In contrast to prescription medications, the FDA does not oversee OTC drug marketing. Instead, the Federal Trade Commission regulates OTC promotion, as it does most consumer products. Overall, the FTC’s marketing regulations are less stringent than the FDA’s (see below for more on this issue).
What Does This Mean For Alli-Related Social Media Activities?
Given that the regulations governing OTC drug marketing are a lot looser than prescription drug promotion, GlaxoSmithKline has more leeway in how it talks about the Alli online and off. This means that the company can deal with key issues related to social media pharmaceutical marketing in the following ways:
-Drug Side Effects: A major fear of pharmaceutical marketers is how they would deal with information about rare or common side effects posted by someone participating in a blog or bulletin board. GSK also has this problem as it is still responsible for reporting side effects to the FDA. However, as Alli is an OTC product the company likely has confidence that the adverse event profile for the drug is well-known. So, while there are rumblings that Alli may cause colon cancer, there no evidence (at least in humans) available to back up this claim. I don't think that GSK will be surprised by an adverse event reported on Alli's message board or blog.
In contrast, a prescription drug marketer has a lot to worry about because they can be very surprised by a previously unknown (or unstudied) side effect that was not revealed during clinical trials (see Vioxx and Avandia for examples).
-Fair Balance: Promotion for non-OTC drugs must be accompanied by what is known by a “fair balance” statement. This means that drug firms must outline – in nauseating detail – all of the side effects of a product. GSK’s critics have complained that the company is obscuring Alli’s side effects by calling them “treatment effects” and omitting scary language featured in Xenical’s (orlistat) label. (Alli is an OTC lower dose version of prescription Xenical.) GSK has no legal obligation to provide detailed information. However, to their credit, they are addressing Alli’s major bowel-related side effect head on.
So, this means that pharma marketers looking to develop a branded blog or other form of social media for a prescription drug must still figure out how to effectively deal with the FDA’s fair balance requirements.
GSK’s Use Of Social Media Is A Great Case Study, But . . .
Overall, GSK’s use of social media is revolutionary for a pharmaceutical company. However, given the stark differences between the regulatory environments for OTC products versus branded medications, marketers must tread carefully. As many pharma execs are already aware, some of the lessons learned about Alli cannot be directly applied to non-OTC prescription drug marketing.
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