The FDA is issuing new rules to pharmaceutical companies regarding how they are to interact with consumers on social media. The rules will not yet have an impact though as companies say they need more clarification from the FDA before they’re comfortable getting back online again, according to The American Medical Association (AMA).
The agency’s draft guidance says all unsolicited information requests be handled in a nonpublic format. The AMA noted that requests include doctor requests for details on the off-label uses of certain medications.
One of the rules encourages all responses to unsolicited requests for information be made in a nonpublic format. That includes requests from physicians for information on off-label uses for certain drugs.
The FDA is also requesting that companies respond to public requests sent Facebook or Twitter, by guided to the appropriate personnel or department for private, one-on-one help. Private responses should be science-based and answer only the question asked, said the AMA.
The new guidance does not affect information or requests received in answer to industry solicitation and do not affect social media sites maintained by physicians or health care organizations, said the AMA. The AMA and some other physician organizations have issued their own guidance to members that includes advising members to proceed cautiously and maintain patient privacy laws when communicating online with patients, said the AMA.
Most importantly, pharmaceutical companies want to know if they are liable for information posted by third parties on social media sites owned and operated by the pharmaceutical companies. How to handle information that could be viewed as reporting an adverse drug event is especially troublesome to the companies.
Industry continues to await a more complete guidance covering all of the aspects of social media with which drug companies say they need the most help. Meanwhile, Kate Conners, spokeswoman for Pharmaceutical Research & Manufacturers of America, said her firm is planning on submitting comments on the proposed guidance. “We continue to wait eagerly for adequate FDA guidance on this issue,” she told the AMA.
According to Ad Age, the “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” which was published in the Federal Register, was quietly posted after a two-year wait.
“What everybody was expecting was actual guidelines around social media,” said Jim Dayton, senior director of emerging media for InTouch Solutions, a pharmaceutically focused digital-marketing agency. “I still think it’s monumental,” he added. “The FDA finally addressed the digital channel in a specific way by mentioning Twitter and YouTube in the document, and those have never been mentioned before. But this is an industry that wants specific instructions and rules, and that didn’t happen here,” he added, wrote Ad Age.
“We understand the level of interest and wanted to get out what we had available to provide guidance,” said FDA spokeswoman Karen Mahoney. Mahoney noted that that this release was just “the first of multiple planned guidances that respond to testimony and comments from the Part 15 public hearing that FDA held in November 2009,” according to Ad Age.
When Facebook ceased allowing drug firms to cut off public comments on their public comment pages in August 2011, many pharmaceutical companies opted to shut down their Facebook pages, specifically pages created for specific medications, explained the AMA. According to the firms, they did not receive sufficient FDA guidance on how to handle social media comments; most said they will keep the pages down until such time as the FDA provides adequate guidance on how to handle comments, said the AMA.
The FDA is accepting public comments on the guidance through March 26.