Oh dear. The longest day of the year is next week and that is my favorite day. Yet it seems I haven’t really enjoyed the full days of sunlight. For example, yesterday I got up before the sun and got home after it had set. That just isn’t right for this time of year. Still, other things happened:
- Zimulti by Sanofi-Aventis Gets No Nod by Advisory Committee – It may be a case of the wrong drug in the wrong place at the wrong time, but Sanofi-Aventis’ Zimulti was soundly rejected by the Endocinrological and Metabolic Drugs Advisory Committee in a unanimous vote. The reason was not efficacy, but perceived issues of safety. This was premised on studies assessing evidence of suicidal thoughts and behaviors in those taking the drug. Despite the unanimous vote against recommending approval, there were comments made by panel members stating that more data is necessary. That leaves the door open to the possibility of a future shift, especially given the fact that the drug, under the name Acomplia, is already approved and marketed in other countries. Time will tell, but the oversight hearing held in the House last week which criticized the FDA for not paying enough attention to FDA Medical Reviewers is certainly something to keep in mind.
- The Danger of Tomatoes Being Addressed – Ok, forgive me, I hadn’t heard this one. Pet food dangers, yes – I’ve heard of that – but not the tomato. Every time I give Nick and Nora a treat, I am now wondering. But I never think anything about slicing a nice ripe tomato and mixing it with my homegrown basil and some mozzarella. But for those of you who do worry about the latter rather than the former, you will be assured by the fact that the FDA has begun a multi-year Tomato Safety Initiative. Phew. While I make light of it, the release from the FDA does state that "[d]uring the past decade, the consumption of fresh and fresh-cut tomatoes has been linked to 12 different outbreaks of food borne illness in the United States. Those outbreaks include 1,840 confirmed cases of illness. The majority of these outbreaks have been traced to products from Florida and the eastern shore of Virginia; however, tomato-associated outbreaks also have been traced to tomatoes from California, Georgia, Ohio, and South Carolina." Ok, but I’m still more worried about pet food. Give me a pet food task force instead.
- Pass the Tissues – Meanwhile, though the tomato is apparently a threat, human tissue is not. The FDA announced that an intra-agency Task Force has announced that practices in the human tissue industry are not experiencing significant industry-wide problems. Tell that to Alistair Cooke.
A curious week in FDA announcements.
