FDA mulls regulating online claims, discussions about pharmaceuticals

While the Food and Drug Administration considers how to regulate drug marketing on the Web, it needs to realize much of the information on pharmaceuticals and therapies discussed on social networking sites is difficult to track, health professionals say.

"FDA should remember that not everything that is happening via the Internet is searchable," said Gilles Frydman, founder of the Association of Cancer Online Resources, a social network for cancer patients that aims to provide credible medical information. He referred to the so-called deep Web, online pages containing databases or password-protected content that a typical search engine cannot catalog.

"None of our content is searchable through any of the major search engines," he said. "But we have tons of patient-reported information about a large number of treatments."

In the future, the cancer patient site plans to "surface a lot of the private conversations taking place in our system," Frydman said. "At that time, the FDA will be able to use machine learning to track in real time [adverse side effects from drugs] and . . . red flag notifications of unexpected issues with any treatment."

But for now, the nonprofit's site and others like it pose a problem for FDA as it tries to find false claims, rumors or misleading advertising about a drug's efficacy. In hopes of finding solutions, FDA invited manufacturers, health care professionals and consumer advocates to an open hearing on Thursday and Friday to discuss policing the promotion of prescription products on the Internet. Currently, there are no rules specific to prescription advertisements or descriptions that are posted online. But FDA regulates promotional materials for products that fall under its purview, wherever they appear.

FDA officials said it would be premature and inappropriate to speak about the technologies and processes it might use to enforce any new policies, but acknowledged they have a surveillance and enforcement program for online marketing.

Government regulations require certain promotional materials be submitted to FDA before they are published so the agency can review the content before it is released online. Personnel at FDA's division of drug marketing, advertising and communications also monitor the Web, and they respond to complaints from consumers, health care professionals and drug manufacturers about questionable marketing on the Internet. In addition, if a particular product is under review for other reasons, FDA will examine that product's Web sites as part of its review.

When FDA discovers potential marketing violations, the agency e-mails warning letters, called cyber letters, to the site's operators to inform them of the rules governing drug sales and tell them to remove content that is not allowed.

For example, FDA sent a cyber letter on Sept. 14 to SKW Ventures, which was marketing unapproved H1N1 flu virus products. "These products have not been approved, cleared or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment or cure of the H1N1 flu virus," FDA stated in the letter. "We request that you immediately cease marketing [such products]."

In preparation for the public hearing, FDA asked manufacturers and consumers to provide feedback on specific issues, including:

--What online communications are manufacturers and distributors accountable for?

--When should third-party online forums be considered affiliated with the companies that market the product, rather than independently operated?

--How can companies comply with regulatory disclosure requirements when using tools that limit word length, such as search results or the blog broadcasting tool Twitter.

Some manufacturers said they want to correct what they view as misinformation about their products on sites outside their control, including blogs, social networking sites or wikis such as Wikipedia, an online encyclopedia that anyone can edit. FDA is exploring the possibility of procedures that would permit companies to fix information on sites controlled by third parties.

Jay Walsh, a spokesman for the nonprofit Wikimedia Foundation, which operates Wikipedia, said in an interview that he was pleased to see FDA tackling such complicated questions. Wikipedia includes many user-generated entries describing medicines with information on the history of the treatment, FDA-approved uses, press coverage and investigational research.

Walsh acknowledged that not every user contribution is necessarily welcome, but "the reality is that all the content of Wikipedia is designed and managed toward providing the most factual [information] available on that product," he said. Experienced editors remove content that is not attributed to existing research. For example, Internet users will notice and delete side effects in an entry that are stated as fact without a citation.

"One of the basic principles of Wikipedia is that we don't permit introduction of original research," he said. "When it comes to articles about human health, medications, human processes, those articles tend to be more scrutinized."

Also, the site's methodical editing process prevents the kind of instant communication of misinformation that other social networking sites may fall victim to, Walsh said. "Wikipedians are generally ahead of the curve" in removing damaging information, Walsh said. "We still appreciate that there is risk."

To assure Internet users that they are viewing accurate drug risk data, an industry group representing pharmaceutical companies is recommending FDA require a uniform emblem, akin to the Good Housekeeping seal, on Web content containing medication information. The so-called universal safety symbol would link to more comprehensive product information.

"As currently proposed, the symbol link could lead to either a government or corporate Web site," said Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America. "We look forward to continuing our discussions with [FDA] and other stakeholders on these important questions."

Frydman said FDA should alert information services like his to the kinds of content they should be looking for on their sites and inform them how to report problems they find to the agency. In turn, FDA should try to learn from organizations like Frydman's how patients search for and use information about pharmaceutical products.

"Putting trust in some new proxies like patient organizations would greatly help the reporting capabilities of the FDA and would certainly provide much faster feedback about [adverse side effects] and also unexpected successes," he said.