UPDATE: The guidance mentioned below was released. Here's the link.
The FDA has released the CDER Guidance Agenda. For ad-promo professionals, the most most significant item is the inclusion of an item labeled:
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products--Questions and Answers
Also notable is that no other advertising or promotional guidances are listed. The draft guidance on presenting risk information turned 10 years old last year. It seemed ripe for an update and perhaps even finalization. That seemed even more likely in the context of OPDP's study of the so-called one-click rule. That study was first announced in 2017. There's no update on the FDA website about the study, but I expected it to be completed last year.
FDA's social science research has clearly been influencing recent guidances, so I assumed (and continue to assume) that FDA would want to update the risk presentation guidance in light of its most recent research about presenting risks, including the one-click study. Apparently, we'll have to keep waiting.
BTW, for those interested in the topic of biosimilar promotion, the Drug Information Association's Advertising & Promotion Regulatory Affairs Conference will have a session covering this topic. Full disclosure: I sit on the programming committee for the conference and will be leading the medical device primer the day before the full conference kicks off.
On Friday, the House of Representatives passed the 21st Century Cures Act. An early draft of this legislation included a provision about social media that would have essentially written the one click rule into law.
This video presents the exchange between Dr. Janet Woodcock, who leads the Center for Drug Evaluation and Research at FDA, and Representative Billy Long of Missouri about that provision (exchange begins at 2:35:35 mark).
Unfortunately, that provision didn't make it into the final version that passed last week; however, one click isn't finished just yet. As I discussed in a new column for DTC Perspectives and another recent article in The Medicine Maker, this is far from finished.
Representative Billy Long of Missouri has sponsored this item as a standalone piece of legislation. In addition, copy and paste is one of the easiest technologies to master, and once draft language is available, there is a tendency for it to get picked up in other efforts that aren't always directly related.
It's worth noting in that regard that discussions have kicked off in earnest about the renewal of the Prescription Drug User Fee Act (PDUFA). The last time this legislation came up for renewal was 2012, and that renewal included a mandate that FDA release guidance about using social media, leading directly to a new national holiday.
At the moment, one click doesn't have a Democratic cosponsor, but I know from conversations with Rep. Long's office that they consider this a bipartisan issue and expect to find a Democrat to sign on. Certainly, from my perspective, there is nothing partisan about this topic. People are adopting social media channels, and there is an incentive for industry to provide truthful, balanced, FDA-regulated information to them. But FDA's current interpretation of the regulations makes it difficult (and frequently impossible) for industry to provide that information.
It is worth pausing to consider the implications of industry's forced absence from these conversations. Of all of the information that is available about prescription treatments, the ONLY information over which the FDA has jurisdiction is promotional communication by industry. So, the only people who are required by the FDA to provide accurate, balanced information are currently being hindered in their efforts to provide that FDA-regulated information.
And as Aristotle (and Gary Larson) taught us, nature abhors a vacuum. Absent industry's involvement in these platforms, others, who don't face the same restrictions, will participate. Some of that information will be accurate; some of it won't. None if it will be subjected to the same high standards required by the FDA for industry's communications.
