The days when pharma reps could discuss off-label uses of their companies drugs are a distant memory for some, and no memory at all for younger reps who entered the business after the FDA issued strict regulations on the matter.
So it was a little confusing when the FDA issued draft guidelines on Dec. 27 on how reps should respond to questions on off-label drug and device use. The regs sounded, well, pretty much like the old ones.
It turns out the FDA statement is specifically looking at the social media exchange of information. The agency wants people who request information from drug makers via an online post or a tweeted question in other words, a public request for information to get a minimal public response, basically a contact us for more information. Then, if the questioner follows up, he or she would get more comprehensive medical information.
This is the same protocol pharma reps have followed for years: Queries about off-label uses of drugs must be referred to medical or scientific personnel who provide an individual, non-public, non-promotional response to the person who requested the information.
In its draft guidelines, the FDA notes that social media have made it easier for consumers and healthcare professionals to quickly search for information about medical conditions and treatments. These days, drug makers could get requests for information through their own websites, chat rooms, or other electronic forums. The FDA states that such posted information is likely to be available to a much broader audience than just the original requester, especially because communication threads are often available for an indefinite period of time. The new draft regulations are intended to give pharma a road map for handling such queries. This might require a few protocol tweaks for pharma, but it won't create any big changes for the industry.
The new draft regulations are timely. According to Manhattan Research (a sister company of HealthLeaders-InterStudy), 45 percent of U.S. adults use social media sources for medical information. In addition, 42 percent of online U.S. adults agree that pharmaceutical companies should be involved in online health communities for consumers. As healthcare reform begins giving an additional 32 million Americans access to healthcare coverage, use of social media for medical information will increase even more.
The expectation for pharma to be active in health communities is quite high, particularly among certain disease states and the caregiver population, said Maureen Malloy, senior healthcare analyst at Manhattan Research. This emphasizes why it's so important that the FDA builds on the guidance they recently issued for off-label discussions. Patients are calling and many brands are trying to determine how to respond.