Consequences of the Lack of FDA Guidance on Social Media (Reid & Senak)
There was a year-end deadline, and much debate over how much (or how little) those new rules would change the approaches that drugmakers took. But we rang in 2011 with no guidance, and the revised deadline of March 30 also came and went with no action, and there is less and less evidence that the agency will ever act.
There are 5 major consequences of the FDA decision not to move ahead:
- Branded promotion has been stunted. Branded promotion online exists, but it has yet to flower, for the simple reason that the risk of being accused of improper marketing far outstrips the benefit of educating doctors and patients. The lack of guidance only inflates this perception of risk and stems the flow of creative ideas.
- Unbranded promotion has been delayed. There are some excellent examples of pharmaceutical companies doing great, creative work online that is providing clear and obvious benefit to the health care system (including some great work by our clients), but these pilot efforts could have been blooming two (or more!) years ago. Instead, fear and uncertainly slowed their trajectory. Now that industry has figured it out on their own, guidance might not have a huge impact.
- The public health has (probably) been harmed. While pharma companies — which arguable have more expertise in certain arenas of health care than any other organization — have been shackled on social media, there continues a rising tide of pseudo-science and fearmongering online. The best way to fight lousy information is with good information. Restricting the ability of industry to join this conversation has been a net benefit to those who with an anti-science agenda.
- Basic questions remain unanswered. No one expected comprehensive guidance, but there has always been hope that the FDA would weigh in on some specific questions, such as whether — in a character-limited environment (Twitter, AdWords, etc.) — pharma companies were required to include or link to an entire package insert. Companies have made their best guesses, but, after years of study, only the FDA knows for sure what the rules are.
- The agency has opened itself to charges of hypocrisy. The FDA has itself become increasingly skilled with its use of social media tools, even as they refused to push out guidance. It creates an unusual and ironic playing field: the FDA has great latitude to use modern communication tools to inform the public through a variety of channels, but it has stymied the industry’s ability to follow suit.
Reid, Brian. The 5 consequences of the lack of FDA Social Media Guidance. WCG, Posted on December 8, 2011. http://blog.wcgworld.com/2011/12/the-5-consequences-of-the-lack-of-fda-social-media-guidance
MarkSenakbelieves as well that the lack of guidance has meant that social media is not being used in an area where it could do a tremendous lot of good – clinical trial support. One example for the use of social media creatively in clinical trial recruitment is with YouTube. PharmaYouTubechannels are notoriously under-utilized and the content has largely been lackluster. Some of the most successful channels in the past, however, have featured patients talking about living with their particular condition. (…)Using patients to talk about their experience taking a specific treatment is risky from a regulatory perspective – they can easily broaden the indication or make a superiority claim if not heavily scripted. A patient talking about what its like to go through a clinical trial – not so much.
Clinical Trials and Social Media – Part 1 in an Intermittent Series. Eye on Fda, Posted on December 12th, 2011.