Weekly Roundup 5.8.15

It is one of my three favorite times of year – the days are so much longer – the evenings cool and pleasant for sleeping near open windows – the mornings crisp and the afternoons languidly warm. Flowers abound. There is a lot of birdsong. It is a good time to be living in the moment and not worrying about the future or the past.

Though speaking of the past, we will cast our eyes backward just a bit to see what the week brought us of interest. And then look onward to the weekend and next week, when I promise an interesting posting about Advisory Committees.

In fact, the folks at FDA must be enjoying Spring too. There were no press releases from this agency, which normally has a lot to say, but which can suddenly from time to time go all quiet. But other than press releases, there were some items of note:

  • FDA Withdraws 47 Draft Guidance Documents – As the entire community of people who waited for 5 years for FDA to come forward with draft guidance documents related to the social media and internet will attest, the agency is not very speedy when it comes to drafting, developing and issuing these important documents. And once the draft guidance documents come out, and the agency collects input through open dockets, a final version may take months, years, and even more than a decade to come into being. This week the agency decided apparently to clean house by announcing the withdrawal of 47 draft guidances that were developed before December 31, 2013 and never finalized. The complete list can be found here, and includes some documents going back to 1991, during the first Bush presidency. It is good to remove the clutter, but even better to improve the process.
  • Senate HELP Committee Questions FDA on Biosimilars – And speaking of guidance, Republicans on the Senate HELP Committee has sent Acting FDA Commissioner Stephen Ostroff a letter to express concern over FDA’s implementation of regulatory pathway for biosimilars. Specifically, they noted that the agency has not provided guidance on a number of fundamental issues, even as biosimilars are coming before AdComms for consideration for approval. The letter stated that the agency has not provided guidance on issues relating to the review and approval of applications for biosimilar products such as naming, interchangeability and production of patent information. They also expressed concern that guidance remains in draft form at this stage and set forth a list of questions that sough answers from the agency by May 22.
  • AdComm Set to Consider NDA for HSDD Treatment – A joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee with the Drug Safety and Risk Management Advisory Committee has been set for June 4 to consider an investigational treatment for hypoactive sexual desire disorder (HSDD). This is significant on a number of fronts. First and foremost, while there are many treatments available for male sexual disorder – erectile dysfunction, there are no approved treatments available for women. Secondly, the meeting comes after a 2-day Public Workshop on the subject held by FDA in the Fall of 2014 – the materials from which can be found here. And third, many therapies have been explored, none have been approved. This is one to watch.

That’s all from me this week folks. Have a wonderful weekend. And next week, look forward to some observations on AdComms.

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