Those speaking during the second and final day of the FDA's public hearings regarding the promotion of regulated products on websites and social-media sites weren't nearly as enamored of the technology as those speaking on the first day. And they weren't inclined to give the pharmaceutical industry much leeway.
"Drug companies should not be engaged in promotion of their products via e-mail, text messaging or social-network sites. It should be done on their own site," said Steven Findlay, senior health policy analyst for the advocacy group Consumers Union. Mr. Findlay said current print advertising guidelines issued by the Food and Drug Administration that require pharmaceutical companies to explain the risks associated with taking a prescription medication should apply to online advertising, where "space is not an issue." He added that "apps for smartphones and other digital devices should have risk information as well."
The hearings were held to establish guidelines for how drug makers go to market on the web, but they are not expected to be implemented for almost a year. Public comments can still be taken until February.
The two-day hearings were prompted in part by the lack of regulations regarding the internet and by the chaos that ensued following the FDA's issuance of 14 warning letters to companies in April of this year. The FDA said pharma companies violated regulations regarding presentation of fair balance, but drug makers, health-care ad agencies and internet sites argued that it's impossible for the same risk information that is conveyed in a 30-second TV ad or a print ad to be duplicated in a 140-character Twitter message or internet banner ad, hence the need for a defined set of guidelines.
The 12-member FDA panel hearing testimony was chaired by Thomas Abrams, director of the FDA's division of drug marketing, advertising and communications.
Advocates for using the web to market prescription medications and medical devices talked about the unofficial "one-click rule," where clicking a hyperlink would take you directly to the risk information.
But Mr. Findlay said that consumers don't click through, and that "companies who have a website that shows all the good stuff" should not make customers click-through to the side effects. The information should be right there.
Said presenter Kim Witczak: "Existing guidelines that apply to print should apply to online. The risks are an absolute must."
Ms. Witczak presented as an individual consumer but she has a vested interest in the hearings from both sides. She is in the ad business, formerly at Fallon, Minneapolis, and she also sued Pfizer after her husband committed suicide six years ago after being on the anti-depressant Zoloft for five weeks.
"I'm torn on the subject," she said. "Professionally, we use [the web] all the time. Pharma companies hire the best and brightest in the business to help build brands. The internet gives us an opportunity to have an ongoing dialogue. But it also has a history of secrecy and anonymity. Prescription drugs are serious business."
Others echoed Ms. Witczak's sentiments, saying that the FDA needs to police the inaccurate information on the web, even at the expense of hiring more people -- money it could easily afford by charging pharma companies more in user fees, several presenters said.
"DDMAC has to hire more people well-versed in interactive media and new technology," said Zen Chu, founder of the health-care social-media company Accelerated Medical Ventures, Boston. "Guidance needs to be specific to each media. That takes people, which means it takes money. So charge more fees. Plenty of companies here have large marketing dollars."
Jack Barrette, a former Yahoo executive and now the CEO of health activist site WEGO Health, said the onus should be on the drug makers.
"We're talking about companies that are big enough to monitor what's happening out there," he said.
But Jonathan Richman, director of strategic planning for the digital agency Bridge Worldwide, reaffirmed the first-day message from the hearings that while the challenges of engaging in social media are numerous, the importance of utilizing new media is just as great.
"Beyond any other marketing issue, this is by far the one getting the most attention," Mr. Richman said. "For more than a year, a number of people have publicly called on the FDA to issue specific guidance around the proper use of social media. I'm optimistic that this hearing is the start of a process that will clarify many of the nagging questions healthcare companies have regarding the proper use of social media. I hope this will open up a new era in communication between patients, doctors, and healthcare companies, all with the ultimate goal of improving patient care."
Rich Thomaselli, AdAge.com November 13, 2009
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