We are at the end of summer. Though not young, my mental calendar is still locked into the mentality regarding the beginning of school. This is the last week to relax before the onslaught of back to school, days full of classes, new people to meet, new subjects to explore. And of course, the coming of Autumn. But first, the last, lazy days to spend at the beach, at cookouts and driving in days that are low in rush-hour traffic.
On that note, I will be taking next week as a end of summer holiday week – so unless something extraordinary happens, there won’t be any postings. However, I will be working on a few things that I hope will interest you when we are “back to school” and in the swing of things.
FDA it seems has already been on vacation – it has been a slow August, but a few items of note:
- Approval for HSDD Drug for Women – Here it is. There has been a long quest to bring to market a drug for women affected by hypoactive sexual desire disorder (HSDD). Back in June, we reported on the Advisory Committee being held to consider approval, having voted 18-6 in favor of a recommendation. Now, the first successful candidate to treat HSDD, Addyi (flibanserin) (and pronounced add-ee) was approved this week by the agency for us in premenopausal women. Much of the media coverage of the approval employed an unfortunate shortcut to describe it – using terms to equate it with male treatments for erectile dysfunction – when it is in fact, quite different. In its press release, FDA stressed that the drug was coming with a Boxed Warning due to its potential effects when used with alcohol (fainting and low blood pressure) and that it would be available as a result only through certified prescribers. The REMS program also extends to pharmacies as well. The treatment, which is not hormonal, was also described by the agency has having a mechanism of action that is not known. The manufacturer – Sprout Pharmaceuticals – said in its press release that it was aiming to have the drug available in mid-October. It was a big news week here as it was also announced that the company was being acquired.
- Consent Decree Related to Supplement Manufacturer – Many times people are under the impression that FDA does not really regulate supplements so it is therefore worth noting when action is taken that sheds a spotlight on the role that FDA has in that regard. In April 2014, FDA issued a Warning Letter to Iowa Select Herbs regarding the misbranding of supplements due to the claims being made in relation to their marketing which would cause them to be drugs rather than supplements. Specifically the claims that FDA centered on related to stated that a range of specific products could treat and prevent very specific conditions. The letter provides a strong example of how FDA can act when certain conditions are present. This week the agency announced that a consent decree which will address the labeling issue.
That’s it for the week, and the summer. Enjoy the last lazy days before the return to school!
