Since my last post on “the future of Social Media Marketing in Pharma,” I’ve seen quite a few conversations pop up around this topic and started ‘listening’ to them. Here’s the scoop:
There’s a great blog on pharma and healthcare at Dose of Digital. Check out some of the archived posts on the sidebar of this blog. It’s evident that the FDA has not clearly defined the rules of engagement in the social media space for pharma and for that matter medical devices and diagnostics companies. The same blog discusses ways to go around current FDA regulations using mobile marketing (But, I don’t think the point is to deceive customers or patients, or maybe it is? But that’s not my focus!)
Recently, Johnson & Johnson was slapped on the wrist by the FDA’s DDMAC (Division of Drug Marketing, Advertising, and Communications) for overstating the efficacy of Ultram ER, a drug for chronic pain, and understating its risks in this Ultram warning letter. In another similar situation, Shire Development Inc was reprimanded for inaccurately featuring Adderall XR Capsules on YouTube. Essentially, the Adderall warning letter claims that the video overstated efficacy and understated the risks, thereby “misbranding” the drug. So were both of these cases deserving of the reprimand?
Before answering that, consider the blog eye on fda and a related podcast that very succinctly discusses the need for pharma’s participation in Web 2.o, pharma’s reservation to do so, and the FDA’s point of view. In brief, Mark Senak of Fleishman-Hillard spoke with Dr. Jean-Ah Kang, who is the Special Assistant to DDMAC Director Tom Abrams. Although I recommend that you listen to the podcast, the script is nicely transcribed at MM&M. Basically, right now the FDA has no formal policy on the use of Web 2.0 social media. The key message from Dr. Kang was: “it’s not the medium, it’s the message.” As long as the message is fair and balanced, it doesn’t matter what medium it is conveyed in, whether it be Twitter, YouTube, website, or other traditional medium such as print. But even so, as a company with a drug or other product in a regulated industry, you still need to cover your a%#. How? Dr. Kang says: “follow the law” by submitting two copies of the final promotional materials using the FDA form 2253 under the guidance of 21 CFR 314.81(b)(3)(i) to DDMAC. If you think your marketing materials require advisory comments on the draft proposal, you can certainly solicit the DDMAC for assistance in advance via their CDER page. What this does is covers you from a third party wrongly reprocessing and misrepresenting your product and brand.
Is it better to have loose guidelines than to have an exhaustive list of rules and regulations spelled out by the DDMAC? Apparently not. The brouhaha continues. Just a few days ago, DDMAC issued draft guidance for industry presenting risk information in prescription drug and medical device promotion. The guidance hardly touches on the use of social media and the Web 2.0 environment. There seems to be an even stronger response to the lack of guidance provided in this document, especially since DDMAC reprimanded 14 companies via “Warning Letters and Untitled Letters” for using sponsored links on Google in March of this year. The letters basically claim: The sponsored links are misleading because they make representations and/or suggestions about the efficacy of _fill in the blank drug_, but fail to communicate any risk information associated with the use of this product. In addition, the sponsored links inadequately communicate _fill in the blank drug _indication and fail to use the required established name. So, if you want to provide input to the draft guidance document, you have 90 days to do so, or you can join the bandwagon with others already planning to!
The landscape is much more complicated than what meets the eye. How do you formulate policy around promotional materials in a regulated industry in a medium that can be altered, such as a wiki, or that must be communicated in 140 characters or less, i.e. Twitter? For example, is it okay to Tweet: “Joe used Viagra and he’s never looked better. Ask your doctor how you can too!” And, even if you can, I wonder what the effectiveness of such new media tools will be for the companies looking to promote their regulated products? And, even more interestingly, how will and should the combination of various marketing channels change to optimize delivery of the promotional message?
I would love to hear your thoughts. Yours truly – startupmarketingdiva.
P.S. follow me on Twitter @startupmktgdiva