WASHINGTON: The Food and Drug Administration released a first draft of social media guidelines this week, providing pharmaceutical companies with a preliminary guide of dos and don'ts to market their products.
The guidelines provide a definition of interactive and promotional media, criteria for determining the necessity of postmarketing submissions, and recommendations for fulfilling regulatory requirements, said Jennifer Fuhrman-Kestler, GolinHarris senior manager.
Fuhrman-Kestler said although the guidelines are vague and coming from the federal government in pieces, they are encouraging because they allow the industry to usher clients into the world of social media. She noted that some had been hesitant because of a lack of clarity on how they could use new media platforms.
The guidelines were focused on FDA reporting requirements on what it calls “interactive promotional media,” and they explain how the agency would decide whether a firm is responsible for information disseminated by third parties on social media. It also listed steps that companies can take to avoid the FDA bringing enforcement action against them in such a case.
Fuhrman-Kestler added that the lack of specificity is due to the FDA not wanting its guidelines to have “a short shelf life” by applying them to a few specific platforms, such as Twitter or Facebook. Firms are hoping to help clients solve challenges such as how to control spammers on websites and determine what can be considered acceptable responses when a consumer is speaking “off-label” about a product's benefits or side effects.
Fuhrman said she does not expect the guidelines to cause significant challenges for marketers.
“These guidelines do not have all the answers because they have to leave some wiggle room,” said Fuhrman. “I certainly think that as these guidelines continue to come out, there are going to be more answers to new questions.”
Guidelines were promised in 2009 as a part of section 1121 of the Prescription Drug User Free Act. Those released this week are only the first of several social media guidelines distributed before the law's deadline of July 9.
“They're forward-thinking and reflective of the environment we live in. We've been waiting for them for so long,” said Fuhrman-Kestler.
Carrie Jones, principal and MD of JPA Health Communications, said she had stopped waiting for the FDA to release social media guides, but is looking forward to giving the government agency feedback as they evolve.
“I would like to remind everyone to talk with your peers and your clients and figure out if the guidelines are specific enough and provide enough clarity so that we can give feedback to the FDA,” she said. “This is a good time to pause and read through them, and to let [the FDA] know what we're thinking.”
Jones said some JPA clients are fearful to make the leap to social media and release information to nonprofit sites that is not completely vetted.
“I'm really hoping our clients will feel more comfortable engaging more third-party groups and engaging directly with patients to educate them and keep them informed of the latest and greatest,” said Jones. “I'm optimistic this will increase the level of information sharing that will ultimately benefit the patient.”