We are enjoying more respite from heat here in the mid-Atlantic. Certainly a difficult week that brought reflection and sadness for many. And so we’ll get right down to some of the things that happened FDA-related that were noteworthy:
- Tragedy in Orlando and FDA Blood Policy – In the wake of the Orlando tragedy that so heavily involved the LGBTQ community, most members of the community were barred by FDA policy from donating needed blood to help treat survivors. In a guidance document issued last year, FDA had revised its extreme policy of defacto deferral of all donations from gay men to one that deferred donations from gay men who had had sex within the past year. (See “The Guidance that Dare Not Speak its Name“). Other countries have followed suit. The tragedy drew scrutiny on the latest deferral policy raising question as to whether or not the new construct was in fact justified. From an issues management perspective as well as a policy perspective, FDA would do well to convene another public forum on the matter and cast the net widely for input.
- FDA Approves Cholera Vaccine – This week FDA announced approval of a new vaccine to protect against cholera. Called Vaxchora, it had fast track designation and priority review status and is the first such FDA approved vaccine. While the FDA release states that the vaccine is intended for travelers, in fact cholera can occur in settings where there has been a breakdown in sanitation, such as in the wake of a natural disaster.
- Device to Treat Obesity Approved – A tube that is surgically inserted into the patient that drains a portion of stomach contents after every meal was approved this week by FDA. The approval is meant to provide another device/surgical alternative for patients who do not respond to non-surgical means of weight loss and the release states that it is intended for use in adults with a body mass index between 35 and 55 over the age of 22 years. According to the FDA, the device will allow patients to remove approximately thirty percent of the calories that were consumed during the meal when used 20-30 minutes afterwards.
That’s all for me this week. I had intended to have a posting with an update on pharma and twitter use, but it is now scheduled for next week. Until then, be well and be safe.