Weekly Roundup 8.14.15

The summer is flying by. The lightning bugs have lit up and lit out. The grass has had it. Vacations are nearing an end. The last of the picnics are being planned. Somewhere someone is busy tuning up the yellow school buses so that in a few weeks time, they will be hauling the kids – some eager, some not – back to their school days. Heck, it won’t even be that long before we are looking at a snow day.

It was kind of a slow week (other than the OPDP Warning Letter re the Kim Kardashian social media promotion), here is a bit of what happened in the past few days:

  • Big Court Decision on Off Label Speech – It was big news – bigger even than the Warning Letter from OPDP that was issued this week. Everyone by now will have heard the news by now that there was a court decision in New York this week that may put FDA on a bit of a leash when it comes to having its way on off-label promotion by a pharmaceutical company. Specifically Amarin Pharmaceuticals brought suit against the agency asserting that if information about a product were truthful and not misleading, then speech about an off label use should be considered a legal exercise of speech. How this will play out is still a bit up in the air and FDA could appeal, though the company said in a press release that it would begin promotional efforts consistent with the court opinion. I almost wrote a posting on this, but there were greater minds doing a better job of it and you can read some of them here on the FDA Law Blog and here on In the Pipeline.
  • Sculpture Protesting FDA Policy on Gay Blood Donation – For many years FDA had a policy that virtually banned blood donations from men who have had sex with men. In 2015, the agency put out a new proposed guideline for blood donation from gay men proposing that blood be accepted from any gay man who has been celibate for a period of one year. While many feel the step is in the right direction, it nevertheless holds gay individuals to a different standard in spite of the fact that donated blood is screened. This week, media reports carried news regarding a new exhibit being put on at the American University Museum  in Washington, D.C. featuring a sculpture that contains blood donations from various gay, bisexual and transgendered individuals encased in resin.
  • FDA Responds to Energy and Commerce Letter Re Warning Letters Back in a June posting in the Weekly Roundup, it was noted that FDA had received a letter from the House Energy and Commerce Committee seeking information on how the agency posts Warning Letters as well as how it decides whether to send a Warning or Untitled Letter. In late July, FDA responded to the letter and it has posted to the House E&C site. The deets are more than we can go into here in the Roundup, but I thought they were interesting.  See what you think as well.

That’s it for me this week. As we wind down the summer, enjoy!

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