Nov. 8, 2016 – When the votes are counted, expect many discussions on what will happen next. One thing is certain – there is change ahead. To get the real skinny on what will happen to medical marketing, attend the Coalition for Healthcare Communication post-election meeting next Wednesday and Thursday in Washington. Speakers from throughout the medical marketing and advertising community will provide their unique perspectives at dinner on Wednesday and during morning sessions on Tuesday.
Meanwhile, several non-election matters deserve your attention:
- Last Thursday night Andy Slavitt, Acting Administrator of CMS noted that many companies have raised prices well beyond inflation. “Mylan and EpiPen don’t even make our top 25 list,” he said, virtually promising more bad publicity ahead for our industry.
- Wednesday and Thursday of this week, the FDA will hear scores of advocates speak on off-label marketing communication. FDA may have some guidance as early as late this year, but expect incremental, not dramatic change. The CHC testimony can be found here: testimony-at-fda-off-label-hearing.
- FDA has sent its fifth enforcement letter of the year. The Untitled Letter to Supernus Pharmaceuticals Inc. cited a KOL video for Oxtellar XR. Consistent with precedent, the video was cited for broadening the indication and for a lack of adequate directions for use. At this rate, the FDA will break all records this year for the low number of enforcement letters.
- And, FDA has proposed to do a research project on the one-click rule. It’s the first step in a long process. CHC is looking for your ideas to inform its comment to FDA, due Jan. 6, 2017.
Register today for the CHC post-election meeting by emailing me at firstname.lastname@example.org, Hotel rooms are scarce but still can be found on your favorite sites, including Expedia and Hotels.com. Indeed, the Trump International, the site for Wednesday’s dinner, still has rooms available.
Stay tuned. We’ll have much more to say post-election.