We are almost through it! Just a few more days.
In the meantime, the more enjoyable aspects of autumn, chilly nights, fires in the fireplace, and brilliant leaves are all upon us. Soon the end of year holidays will be upon us. In the meantime, a few interesting things from the week:
- OPDP Issues Fifth Warning/Untitled Letter of 2016 – To say that it has been an anemic year from OPDP’s enforcement letters is a bit of an understatement. This week the agency issued its fifth of the year and if it does not double that number in the next few weeks, it will be the lowest level of enforcement seen from this office of FDA. The untitled letter cited a video for Oxtellar XR – an extended release tablet indicated for adjunctive therapy of partial seizures in adults and children 6-17 years. The product has some specific risks associated with use in the label, including warnigns of anaphylactic reactions among others. The video was cited for a lack of adequate diretions for use because of the specific language used in the video that OPDP felt broadened the indication of the compound to include all seizure types and because the presentation did not present risk information in conjunction with the benefits. Of the five letters issued this year, four were Untitled Letters and one was a Warning Letter.
- AdComm Gives Up Vote on Nocturia Candidate – A meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee voted 14-4 in favor of the benefit/risk profile of SER120 (desmopressin nasal spray) for the treatment of nocturia – a condition in which adults awaken two or more times a night to urinate. If approved, it would be the first treatment approved for nocturia, though there have been previous attempts. In January 2015, a tablet formulation put forth by a different company and reviewed by a different advisory committee, resulted in a negative recommendation.
- How Much of the Economy is Regulated by FDA? For many years, many people (including this people) have touted the characterization that FDA regulates one-fourth of the U.S. economy – or in other words, regulates 25 cents of every dollar spent. In a blog posting this week, FDA put that characterization to pasture with a new study by the agency’s staff economists that takes it down a peg – with FDA regulating one-fifth of the economy, or 20 cents of every dollar spent – a level that has apparently held steady over the past five years. The study was done analyzing expenditure data from the Bureau of Economic Analysis (BEA). I stand corrected.
Enjoy the weekend everyone. And get out and vote, if you haven’t already.
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