Indeed, the FDA is proposing a set of guidelines, outlining the types of apps that it plans to oversee. This won't be all apps in the "Health" category, but will include those that, in the FDA's words, "could present a risk to patients if the apps don't work as intended."

But the FDA says that it needs to do more to make sure that consumers and medical professionals are getting accurate information when they turn to their mobile devices for information and diagnoses. There are apps, for example, that warn breastfeeding mothers which medications to stay away from, ones that help monitor heart irregularities and ones that offer basic diagnostics and disease information (such as WebMD).

The FDA says it doesn't plan to review all medical apps. Rather it will monitor and approve those apps that are used as an accessory to an FDA-regulated medical device or that transform a mobile platform into a regulated medical device. Based on the wording in these draft guidelines then, the oversight will be geared towards apps that are aimed at medical professionals, not at the general public.

The general public is, of course, welcome to give the FDA feedback on these proposals. FDA is asking for consumers, health care workers and others to weigh in on its proposed guidelines during a 90-day public comment period.

The widget was encouraging people to share content that misrepresented the drug, the FDA said in its letter, which it publicized last week. The letter also mentioned the "Share This" tool, which the agency said raises similar issues about other social media sites. But the offending text in the Facebook Share widget was drawn from the source's metadata, content that is written for search engines and usually does not appear on a web page.

The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug. In addition, the shared content inadequately communicates Tasigna's FDA-approved indication and implies superiority over other products. Thus, the shared content for Tasigna misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA implementing regulations.

A screenshot showing the widget before Novartis took it down. [via John Mack]

The FDA also dinged Novartis for failure to submit the Facebook Share widget for approval as is required for pharmaceutical promotional materials.

Illegal text was from site metadata

The articles and images in the widget were drawn from online content generated by Novartis. The description of each link was pulled from the meta description in the page's code, which was also written by Novartis. Normally, that text is less than 200 characters and is visible to users on the results page of a search engine.

Novartis removed the Facebook Share widget after the FDA's request, but it also made another change. The company edited the description in the metadata of each page to conform to FDA rules.

Metadata not exempt

The FDA letter does not mention metadata. But the same rules that govern advertising, labeling and promotion also apply to metadata, according to a regulatory alert issued by healthcare marketing agency Digitas Health.

And this isn't the first time the FDA has taken issue with metadata, Digitas Health said - Sanofi-aventis received a letter in March 2009 for metadata on a website for the drug PLAVIX, prescribed to prevent strokes and heart attacks. "The letter received little comment at the time because it was released on the same day as 13 other letters relating to paid search engine marketing. Few people noticed that the infraction cited by DDMAC (the FDA's Division of Drug Marketing, Advertising, and Communications) related to organic, non-paid search engine results," Digitas Health said in its regulatory alert.

Metadata violations not uncommon

Social media has been on the FDA's radar for some time. The agency held so-called Part 15 hearings seeking input on a set of social media guidelines in November last year.

But metadata, which has been appearing in search engine results for a decade, does not seem to have been as high a concern. Some quick searches for popular drugs showed some companies are careful about what statements appear on the search engine result page. But others are not, posting text that could potentially constitute a violation if they appeared in an advertisement or on a website.

We're not lawyers. But the FDA cited Tasigna for making "representations about the efficacy" but failing to "communicate any risk information." This site description would appear to make representations about efficacy by saying Zyrtec "provides relief."

Trying to spread the word about the dangers of Salmonella-infected peanut butter forced the HHS, FDA, and CDC to get creative. Leveraging social media to spread the word, proved to be the point on which the agencies could quickly combine forces. According to Nextgov, the various health agencies gathered to brainstorm ideas, propose various forms of social media outreach, and collaborate on launching the campaign.

"We tried to use every available form of media," said Dick Stapleton, deputy director of the Web communications and the new media division at HHS.

The avenues employed by the agencies included blogs, texting, mobile versions of agency Web sites, online video from the FDA and CDC on YouTube, podcasts, XML files and RSS feeds including "CDC Emergency Preparedness and Response," social network outreach on sites like MySpace, a variety of Twitter entities like @FDArecalls and @CDCemergency, virtual worlds, and widgets. The various channels carried both breaking news as well as education information on Salmonella.

Previously, inter-agency collaboration was all but non-existent, as Stapleton explained to GovHealthIT:

"Traditionally, [HHS] is a very siloed organization, with the CDC, FDA and other agencies doing their own thing and the public left to go to individual agency pages to find out about what is going on," he said. "We have a lot of potential resources, but they are scattered."

Social media not only enabled the agencies to accelerate outreach, it made the health organizations more social, themselves, by introducing a means of collaborating among the formerly disjointed departments.

And while it's hard to pinpoint how many potential illnesses or deaths were prevented, it's safe to say that far more people were aware of the dangers of Salmonella-tainted peanut butter thanks to the social media efforts of these agencies.

Where Do We Go from Here?

Hopefully, this is just the first step - rapidly disseminating information - of many for incorporating Web 2.0 technologies into these agencies.

With continued adoption, one can easily imagine the possible advances in protecting the populous from disease before it happens - like employing technology similar to Google's flu trends combined with social graph information. And that's only one example.

Here's hoping the health agencies continue to break new ground - and continue to collaborate - for all of our sakes. That's when social media will truly become a way of life.