A Look Back at 2013 and FDA

Happy New Year!  It is natural for each of us to look back on the year and see where we did well and where we stumbled and also to assess how the past year might shape the one to come.  Here is a little overview of events that shaped the FDA landscape this year:

• Legislation and FDA Authority – Occasionally FDA gets new regulatory authorities as a result of legislation passed by Congress.  Despite the fact that this Congress has not produced as much legislation as others have, the Congress did pass and the President did sign legislation – the Drug Quality and Security Act – that gives the agency new authorities in regulating compounding pharmacies.  The action came after several high-profile recalls during the course of the year that resulted in Congressional hearings, FDA testimony and consequential legislation.  An overview of the compounding issue events can be found at the blog web site tab on Compounding.
• Guidances – Related to the passage of the above mentioned legislation, FDA developed pharmacy compounding draft guidances in record time, indicating that FDA was not only eager for the compounding authority, but was quite ready to accept the authority once given by the legislation.  By my count, I saw 29 guidance documents issued last year – 3 of which were about pharmacy compounding:  (1) Interim Product Reporting for Human Drug Compounding Outsourcing Facilities; (2) Registration for Human Drug Compounding Outsourcing Facilities, and (3) Pharmacy Compounding of Human Drug Products. In addition to these draft guidances on compounding, an additional draft guidance of interest to those in communications would be Product Name Placement, Size and Prominence in Advertising.
• Drug Approvals – While last year, there were a whopping 39 approvals last year, there were only 27 new molecular entities approved this year. That said, there were some important approvals among those 27, including new treatments for Hepatitis C and one new treatment in prostate cancer.  Aside from new molecular entities, also of note this year was the approval for OTC status of the contraceptive pill Plan B – often called the “morning after pill” which had the rockiest road to OTC status of perhaps any drug – among other things first being approved for women 15 years and older and later for all women of child-bearing age.
• Device Approvals – There were over 30 device approvals during 2013 – one of which was approved to reduce the frequency of epileptic seizures in patients who have not responded well to medications and another of interest which was the first device approved for use in the treatment of migraine pain relief.
• Social Media – Of course, the one thing that didn’t happen in 2013 was the same thing that did not happen in any year since 2009 when FDA held a public meeting about the regulation of product promotion via the Internet or through social media.  Long termed a priority, the development of a guidance resulting from this meeting is still to come.  Word on the street is to look for the draft to come out before or during July 2014 when there is a legislative requirement. Note, however, it is not unprecedented for the executive branch to let legislative requirement deadlines come and go. (Meanwhile FDA is now running 13 different twitter feeds – a new one which was added this year – the @FDA McMi feed, a Facebook page, Flickr and a YouTube channel.  You can view all FDA tweets from the Eye on FDA listing of all FDA Tweets.)

As for Warning and Untitled letters, that will be the subject of a separate posting.  The posting of these letters on the FDA site sometimes has a lag time and so that analysis will come a little further into the new year.

Again best wishes for the new year.