FDA Considers How Drug, Device Companies Can Participate Online

The FDA’s crackdown earlier this year on prescription drug search ads produced a less-consumer-friendly environment, said David Zinman, Yahoo vice president and general manager of display advertising. The FDA sent letters to pharmaceutical companies warning them they needed to include risk information in the search ads. But search ads are a “tightly defined space,” Zinman said, limited to 145 characters for title, description and URL. With no room to add risk information, drug companies instead removed brand- specific information that would trigger FDA requirements, he said. Now the URLs are masked -- for example, as managebloodpressure.com or bloodpressurecholesterolrx.com -- rather than using a company or drug name, he said. “We've resulted in a world where users have less transparency,” he said.

Google representatives agreed with Yahoo that the FDA letters resulted in less useful search results. Amy Cowan, head of industry, health, at Google, said the click-through rate on ads was steady throughout 2008 but dropped dramatically after the advertisers instituted new language following the FDA letters. Before the letters, she said, people were clear they were clicking on an advertisement. She said Google recommends standardized formats for ad search results across the Internet. The standardized form would include the brand name, risk information and two links -- one to the drug site, and one following the risk information labeled “more info” that would take the user directly to a more detailed description of the risks. She said Google recommends two formats -- one for branded drugs and one for “black box” drugs, the drugs with the strongest warning labels.

In general, however, the Internet can offer more transparency, speakers said. Users understand how links work, said Wayne Gattinella, CEO of WebMD Health Corp. They use links to drill down into the details of their specific concerns, he said. Links shouldn’t be considered a way to hide information, he said, but a way to ensure people are getting the information they want at the correct time. If people aren’t clicking on links, then the site is doing a poor job, he said.

But links are inadequate, said Diana Zuckerman, president of the National Research Center for Women & Families. “I think ‘one click away’ is one click away too many,” she said. While print and broadcast ads cost more money for every bit of additional information included, the same can’t be said for the Internet, she said. Therefore, a product’s risks should be “as prominent and as persuasive” as the information about its benefits, she said. She cited as an example the new product Latisse, which is the “first and only FDA-approved prescription treatment for inadequate or not enough eyelashes.” The information on the Internet is “very promotional,” she said, and doesn’t state the risks in clear language. For example, it’s not clear that the warning that using Latisse “may also cause increased brown pigmentation of the colored part of the eye which is likely to be permanent” means that it could turn blue eyes brown, she said.

Zuckerman suggested the FDA establish relationships with the most-used Web sites to ensure they maintain correct and balanced information, acknowledging that regulating all sites on the Internet is difficult. For example, she said, the site drugs.com, which appears to be a reputable site, doesn’t include a caveat about the drug Vytorin that the FDA has required the manufacturer to include on its site. Wikipedia has an open, egalitarian system, and prohibits companies from promoting themselves on the site, she said. Some entries on drugs and medical products are balanced, but others appear practically as advertisements, she said. Wikipedia is biased in favor of people who edit a lot, she said, so if a drug company were to hire someone to work full-time on such projects, it’s unlikely they would be caught. She said the entry on breast implants has been repeatedly edited by one person and when others have attempted to enter negative information from journal articles or the FDA, that information has been disputed and deleted.

Industry is also trying to figure out how it can enter the social media universe. Robert Winder, CEO of VuMedi, a site for orthopedic surgeons, said device manufacturers are confident in sponsoring traditional meetings and journals but are unsure of sponsoring sites like his, meaning it currently has only four sponsors, though more are interested. On his site, he said, surgeons can watch videos of surgeries and download technique guides for new devices. They get the education they would formerly have gotten at conventions and the device makers have an opportunity to sell their products, he said.

Sites meant for the general public are trickier still, especially when it comes to discussions of off-label use. Industry has an obligation to participate in online discussions in a transparent way as it has the expertise, said Tiffany Mura, director of digital at Consensus Interactive. It’s not a question of advertising but of getting information out, she said. Craig Audet, vice president of U.S. regulatory affairs for marketed products for Sanofi-Aventis, said companies should submit their “static” marketing elements to the FDA, as they do now, but shouldn’t be required to submit things like visitor postings and the company’s response to visitor questions. Those postings are akin to the conversations a salesman in the field would have, which don’t have to be reported, he said.

A panelist, however, questioned the similarities, saying a salesman’s conversation isn’t available for millions to see indefinitely. Audet said the company’s representatives are trained to give balanced answers, so any answer appearing online would be balanced. “The point that it would be enduring is fairly irrelevant,” he said. The logistics of submitting all such postings would be daunting, he said, although if the FDA wanted to pursue such a regulation, he suggested requiring batch reporting. If someone posts a question about off-label use, the company medical staff should respond and the wider site community made aware that the question applied to off-label use, said Mark Gaydos, senior director, U.S. regulatory affairs for marketed products for Sanofi-Aventis, speaking on behalf of the industry-sponsored Social Media Working Group. The company doesn’t want to hurt the doctor-patient relationship by appearing to say a particular use of the drug is wrong, nor does it want to censor comments, he said. However, it’s probably appropriate to remove the post after a “reasonable” amount of time and after having left a response, he said.