Last year the campaign for Chimerix to give an experimental cancer drug to a 7-year-old gave biopharma firms another reason to be wary of the power of social media. Having seen Chimerix be engulfed by the social media maelstrom, BIO is working to equip small biotechs with the skills they will need if they find themselves in a similar situation.
The FDA has released a list of almost 100 draft drug guidance documents it plans to introduce or update in 2015. The documents cover a range of biotech IT-related topics, including electronic informed consent in clinical trials, links to third-party sites in social media adverts and statistical approaches to showing biosimilarity.
In the realm of drug industry enforcement, the Office of Prescription Drug Promotion is like a meter maid. OPDP citations aren't as scary as warning letters from other FDA enforcers that can shut down a manufacturing plant or clinical site. And they certainly aren't subpoenas from the Justice Department.
The explosion in online discussions about medicines and the rise of social-listening tools to mine and analyze the data have given drugmakers another way to learn what patients think about their products. But pharma companies aren't the only ones listening. Wall Street has its ear to the digital grapevine, too.
An attorney whose practice is focused on medical device law has called into question the FDA's authority to regulate devices that are promoted on social media platforms like Facebook and Twitter.
Pharma's social media evangelists have been urging companies to lend an ear to the chatter on Twitter, Facebook, patient forums, physician networking sites and the like. It's a way to engage with patients, monitor doctors' opinions, tailor marketing and spot safety concerns, they say.
Now, it's U.K. drug regulators who are devising plans to eavesdrop on social media. But unlike the FDA, which plans to monitor the world of online sharing to see whether its communications are hitting their targets, the Medicines and Healthcare Products Regulatory Agency plans to search for drug safety info.
A Wall Street Journal feature this week on researchers' long-standing concerns about the consequences of patients talking about clinical trials online digs into how biopharma companies are tapping technology to counter concerns about unblinding and manipulating inclusion/exclusion criteria.
What's #FOGO? Hint: Many of us have it. Another hint: Pfizer wants people to talk about it.
The FDA may be having problems handing down its social media commandments. But it's playing enforcer just the same.