Big Pharma is making one last push to the Food and Drug Administration urging the regulatory agency to quickly adopt new guidelines for marketing on the web and using social-media tools.
«Right now there are no internet-specific standards on how manufacturers can use these media,» said Jeffrey K. Francer, assistant general counsel for the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA). «The lack of such standards is chilling the use of such technology.»
The FDA held two days of public hearings in Washington last November to take testimony on establishing guidelines for how the pharmaceutical industry goes to market on the web. More than 60 speakers were given 10 minutes each to talk on the topic, but the FDA took public comments in written form through the first week of March.
The hearings were sparked by the controversial issuance of warning letters to 14 companies in April 2009 for search-engine ads that the FDA said violated regulations regarding presentation of fair balance. The industry countered that the regulations requiring disclosure-of-risk information in print and broadcast ads should not be applied to internet ads that only contain 12 words on Google ads, or 140 characters on Twitter.
PhRMA, Pfizer and Merck were among the many that beat the deadline and took advantage of the public comment period to be more expansive than a 10-minute speech. PhRMA sent the FDA a 16-page letter, issued a statement and held a conference call to reiterate its call for an FDA logo or link on an ad that would denote that the ad is regulated a sort of «Good Housekeeping» seal of approval and allow the user to one-click their way to safety information.
PhRMA also wants the FDA to clear the way for drug makers to microblog newsworthy events, just as the FDA uses its own Twitter feed for such news.
In PhRMA’s statement, Senior VP David E. Wheadon said: «At a time when more than half of adults first turn to the internet to find health information, the extraordinary volume of dangerous and inaccurate information about medicines on the web makes the FDA’s leadership on this topic all the more essential.»
Indeed, in its own 16-page letter to the FDA, Pfizer detailed the results of its search-engine experiment, which concluded with fascinating some might say stunning results. Using WeissComm Group to conduct searches on Google relating to eight different Pfizer products last month, the drug maker found that only 22% of first-page results and linking sites were regulated by the FDA. The company used only first-page results, noting that 90% of those who search for information online do not look beyond the first page.
The remaining 78% of the search results took users to unregulated sites such as international pharmacies, spam sites, user-generated sites, blogs and attorney sites for lawsuits.
«Absent a comprehensive new set of regulatory standards for product communications through the internet and in the social media setting that encourage manufacturers to engage in these new media, subject to appropriate FDA oversight, the conversations taking place in these media will remain largely unregulated,» Pfizer senior VP-associate general counsel Geoffrey Levitt wrote to the FDA.
Merck’s letter to the FDA was 12 pages long and advocated for the «one-click rule,» and also called on the FDA to create a new panel to oversee the liquid nature of Web 2.0.
«Since the internet and associated tools are ever-changing, FDA should consider the establishment of an Advisory Committee comprised of key experts (including consumer advocates, representatives from the medical community, technical experts and industry representatives) to review issues periodically that involve the communication of product information over the internet and via social-media tools,» wrote Sandra A. Kerr, Merck’s Office of Medical/Legal senior director. «Such a committee could exist as a subcommittee to the FDA Science Board or the Risk Communication Advisory Committee.»
It is not known how long it will take for the FDA to issue new guidance on social media.