As director of regulatory advertising, promotion and global labeling for Shire Human Genetics Therapies (HGT), Cynthia Phillips supports the marketing team to ensure compliance for all materials and activities in the US and Canada. Her aptitude for and interest in technology has driven her to initiate dialogue about how pharma and regulators might best navigate the Web 2.0 world. This year, Phillips has given Web 2.0 presentations at three conferences—not as a representative of Shire but as a regulatory expert.
“There's been no guidance from the FDA on the Internet, let alone social media, and we're not anticipating it,” she says. “We're all trying to figure it out. There's tremendous opportunity for marketers to educate medical, legal and regulatory leaders about these new initiatives and get them comfortable with what's going on.”
Phillips adds that marketers often speak jargon that regulators don't understand, which makes it easy for them to tune out. She thinks it's critical that agencies and marketers understand regulations and regulatory speak, and she notes the importance of considering legal issues in tandem with regulatory issues. She also feels pharmas can expand thinking about advertising and promotion to include medical, legal and regulatory in the process.
“Rather than not doing something for fear they're going to say no, teach marketing, legal, regulatory teams about Web 2.0,” she says. “Send them sample websites and tell them what you'd like to do…and ask them what issues they see. Get them involved early, and give them tools.”
Clearly, there's uncertainty and risk involved as pharma intersects the web. A perfect example is the FDA warning Shire got this fall regarding a testimonial video for Adderall XR that someone lifted and posted on YouTube without risk information. Phillips wasn't directly involved, but she notes the importance of protecting information online. “People can post anything,” she says. “They can talk off label, and you have no control. If you try to control it…that opens you to being accused of promoting off label. People can pull anything off any website. Make sure your sites have met regulations. Make sure downloadable information [includes] safety information.”
“The FDA is poking around on the Internet, and they'll discover things on their own,” Phillips continues. “They're curious. But they're still applying the same regulations—whether it's print or the web.”
Social media can provide incredible insight into patient populations, but monitoring also presents regulatory challenges, including questions around ownership and reporting adverse events. Phillips explains that Shire “has a good understanding” of its HGT patients, but she adds that social media monitoring can provide “a ton of really good information” that companies can use to inform marketing.
Phillips began her career 26 years ago as a temporary secretary at Merck. She became a sales rep after earning her BS in management (and later an MBA in eCommerce). Over the years, she has seen a lot of industry changes. She says cost pressures, issues of truthfulness and transparency, and tightening of controls on CME grants will all continue.
“It's difficult for reps to even get in and talk to doctors about products,” she adds. “This is all sending a clear message that we need to redo our thinking on selling products. We need to be open, transparent, honest and present safety information without hesitation.”
She also notes that the FDA, pharma companies, agencies, and physicians need to recognize that the role of consumers in healthcare is changing. “In the Web 2.0 world, consumers talk to one another,” Phillips says. “They believe each other more than they believe physicians and certainly more than the pharma industry. There's potential for a lot of incorrect information to be flying around. We need to [ensure patients] are educated and know where to get good, useful information.”
Director, regulatory advertising and promotion,
2005 – 2007
Director, promotional compliance and global labeling, Bristol-Myers Squibb
1982 – 2005
Statistical secretary, Merck Sharp & Dohme to dir., promotional regulatory affairs, AstraZeneca