This week we learned from iHealth that the FDA issued a draft on social media guidance for drug and device makers. This is quite important as pharmaceutical companies and medical device manufacturers while producing a helpful product, are not your “friends”, despite friending you.
Simply put, when you are deciding whether to use a drug or medical device, it is important to have ALL the information. This means that drug and medical device makers must highlight the risks of the products along with benefits via social media channels.
According to the Wall Street Journal‘s “Pharmalot,” FDA must finalize the guidelines before a July deadline that was established under a 2012 law, which requires the agency to offer guidance on product promotion on the Internet (Silverman, “Pharmalot,” Wall Street Journal, 6/17).
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For example, the manufacturer would have to specify whether a hypothetical memory loss drug was for “mild to moderate memory loss,” rather than just for “memory loss.” The draft guidance notes that there might be limitations in character space on some social media platforms, which “may not enable meaningful presentations of both benefit and risk,” especially for products with “complex indications or extensive serious risks.”
The draft guidance bids correction of misinformation posted by others in forums and chat rooms that give incorrect claims by the drug and device makers.
In a blog post about the draft guidance, Abrams wrote,
“These documents strive to ensure that the information provided by drug and device companies is accurate and will help patients to make well-informed decisions in consultation with their health care providers” (Abrams, “FDA Voice,” FDA, 6/17).
Separately, Abrams said the guidance is
“intended to have a beneficial impact on public health,” noting that the regulations were “not developed in a vacuum. They were developed with careful consideration and with input from industry and many other stakeholders. There was a lot of important consideration given to the issues” (“Pharmalot,” Wall Street Journal, 6/17).
These guides by the FDA are keys in helping us make health decisions for ourselves in an evolving patient-centric model. Knowing the facts and the whole story will help us in the healthcare realm.
Do you go into chat rooms or participate in forums to discuss health issues? Share your views and experiences in the comment box below.