Pharmaceutical sales and marketing has become increasingly challenging over the last several years for a number of reasons. Rising patient loads resulting from the aging baby boomer generation have overloaded doctors, leaving little to no time for physicians to see pharmaceutical sales representatives. The average interaction time between a physician and sales rep is now less than 30 seconds in primary care settings. Industry regulations have gotten much stricter as well, creating numerous obstacles for pharma manufacturers.

For example, the American Medical Association's (AMA) Physician Data Restriction Program (PDRP) allows doctors to opt out of sharing prescription information, making it more difficult for pharma's to analyze market trends and identify physicians to target. Even more challenging are the new OIG regulations and the Physician Payment Sunshine Act. Popping up now on a state-by-state basis are regulations the severely limit not only the amount of money pharma's can spend on promotional activity towards each physician, but more importantly, the type of promotion. Due to limited office hour availability, many sales reps have relied heavily on offsite visits, such as dinners and lunches, to capture doctors attention and share promotion presentations with them. The new regulations largely prohibit these activities, especially in state's like Massachusetts. As a result of these growing challenges, pharma's are quickly searching for new avenues and mediums to harness for effective delivery of sales and marketing information. This has placed social media advertising at center stage for pharmas, as they look to tap into the biggest marketing technology wave in years, but cloudy regulations surrounding this medium have caused significant controversy and frustration for the industry, as they scramble for a legitimate way to get involved.

While social media marketing through outlets like Twitter, Facebook, and other web 2.0 platforms have been hugely successful for almost every industry, pharmaceutical companies have largely been sitting on the sidelines, largely due to three reasons. First, social media marketing lacks control, and pharmas fear distortion of their branded messages. Second, current FDA directions on regulatory compliance guidelines surrounding social media marketing are extremely vague and difficult to interpret. And thirdly, pharmas fear exposure to class-action lawsuits resulting from their responsibility to track reporting of adverse events via social media platforms. Although these obstacles have kept pharmas largely on the sidelines when it comes to social media, the industry realizes it desperately needs to get involved to help bolster sales and expand current marketing tactics. This is especially true during this age of massive patent expiration and thinning product pipelines. In response to industry outcry, the FDA recently held a hearing to collect information and opinions from many different stakeholders involved in the situation (manufacturers, wholesalers, industry organizations, social media companies, etc…) so they could assess all viewpoints and ultimately create new rules for the industry to follow that include more well defined guidelines. No new regulations are expected to be announced for several months, but many are hoping the information collected in the hearing will be enough for the FDA to release some stopgap guidelines, allowing pharmas to begin taking baby steps to get involved, while the industry waits for more complete regulations to be released some time next year. One approach to this would be to get some short term guidance around specific mediums. Rather than the FDA taking a universal approach, stipulating that marketing guidelines apply to all advertising regardless of medium (print, online, etc…), guidance that varies by medium would actually be more appropriate. It does not make sense for a manufacturer to be required to include all the same information in a search listing, as they must include in a full page ad. Likewise, limited character availability in a Twitter "tweet" should dictate different information inclusion requirements than a banner advertisement. Two ideas presented at the hearing that go hand-in-hand included the suggestion that the FDA should allow certain warnings to be accessed via a prominently labeled hyperlink, and that the FDA should create an approved logo, or safety symbol, to be used along side ads that links to pharmaceutical company's FDA mandated risk information. On the flip side, some consumer advocate groups argued that pharmaceutical companies should not be allowed any involvement in promoting their products via e-mail, text messaging or social-network sites, and should only use their own website, where full disclosures can always be displayed.
Of equal, if not greater, importance is establishing clear guidelines around what type of adverse event reporting pharma's are liable to capture and report in social media environments. Without them, class-action lawsuits are too large a threat, which will keep pharma involvement in web 2.0 at bay. Unfortunately, this topic will likely take longer for the FDA to solidify new guidelines. No specific dates for FDA "conclusions" has been set, but the information shared at the hearing certainly has set the FDA's wheels in motion, which is a positive step for the industry.