DRIVING HEALTH INNOVATION WITH NEW SOCIAL MEDIA COMMUNICATIONS POLICIES

Alloutcoach

I recently had a truly unique opportunity to discuss a complex yet rapidly evolving topic of how to use and update our social media and digital communication policies with social and healthcare responsibility while improving our impact on the quality and timeliness of medical decisions! Darshan Kulkarni, PharmD, MS, Esq is a dynamic expert educator in this field who owns his private law firm, is a life sciences counselor, speaker, author, board member, and host of the DarshanTalks podcast who shared his perspectives on the latest developments in this field. Below are the highlights from our discussion.

6:20 Pharma and device social media / digital communication policies are highly variable across small and mature companies. Some smaller teams are building them from scratch, yet others are not updating them either deliberately, not prioritizing them, or are not addressing off-label discussions and their impact. 7:52 There have been several court cases that have admonished the FDA for being overly aggressive with its enforcement. The FDA released a 60-page memo in which it acknowledged that it does not know what to do with off-label discussions in social media or via multiple digital channels.8:30 In 1998 there were 195 or so warning letters from the FDA's DDMAC division and last year there were only 6. The FDA is trying to get its bearings on what is happening. Many companies have not updated their HCP engagement policies. The Pharma organization updated its policy in mid-January. There are discussions around "space limited" engagements. On social media, you have to decide whether or not your will have social media pages that are product based, company based, or claims-based. 11:44 What are any differences in risk and liability of a Medical vs Sales organization in pharma today? The DOJ had several court cases in the early 2000s that said either you have a Medical Affairs department that is absolutely separate or you both abide by commercial speech standards, not Amendment 1. For decades, the FDA regulated based on approvals, so if the requirement based on the standard of "truthful not misleading" is thrown out it may upend the entire regulatory schema that existed. So the court responded that the 1st amendment has been changing since the 1980's but the FDA has not updated it. 16:03 The FDA is convening a Task Force to address 1st Amendment application concern in pharma. 17:22 Most pharma companies are still operating under a clear distinction between Medical and Sales from early 2000s but this will likely change in the next 2-5 years. 17:40 Q: What are some types of social media activities that are safe vs others that are more scrutinized? 21:48 CDRH in Medical Devices has significantly less resources than CDR's OPDP in pharma, and this is why the regulations in medical devices are much more loosely defined. 25:05 Has the line of "misleading" changed over the last few years? How can we balance the misleading medical information used by patients themselves? 27:05 Confident and Reliable Scientific Evidence (CRS) FDAMA114 - lowest level of truthful not misleading information. The second is Substantial Scientific Evidence (SSE) which is rarely if ever used. The third level of information used for claims is Substantial Evidence, classically referred to as two randomized controlled studies (RCTs) needed for drug approval. The New Patient Focused Drug Development FDA guidance is now advocating for pharma to communicate with patients. EMA has lay summaries to communicate clinical trial results in a language accessible to the general public. Many ICMJE journals now require for trial sponsors to provide a lay summary for patients prior to consideration of publication. 41:20 How are the current latest regulations impacting how transparent we can or have to be in reporting clinical trials? There are 7 levels of clinical trial transparency (discussed in detail).