It has been a really busy week with travel and work that last Friday I didn’t even get to the Weekly Roundup. The schedule has been so busy, leaving no spare time for either posting here on the blog or continuing to clear away the dead growth in the garden. We have had a few minutes of Spring that already seem tempted to ebb into humid muggy days that we should not get till Summer.
But here is a bit of what I saw that happened when I came up for air:
- Compounding the Issues Around Compounding - Three developments transpired this week regarding the increased scrutiny around compounding pharmacies in the wake of an outbreak of meningitis due to sterility issues. Taking them in chronological order – on Monday FDA issued an alert about the lack of sterility regarding products from two compounding pharmacies and serving notice of an impending recall. Then on Tuesday, the House Energy and Commerce Committee held a hearing entitled “A Continuing Investigation into the Fungal Meningitis Outbreak and Whether it Could Have Been Prevented” that was held nearly simultaneously with the release of a report by the Committee entitled “FDA’s Oversight of NECC and Ameridose: A History of Missed Opportunities“. Dr. Hamburg’s written testimony is available on FDA’s Web site, as is her testimony from a previous hearing held by the committee on this topic in November 2012 as well as a hearing before the Senate. Given the lack of clarity about FDA’s authority with respect to compounding pharmacies, it is probably an issue that is going to continue to be the subject of further public discourse.
- Eye on FDA Tab on Compounding – Accordingly I have developed a tab on the blog that will be a repository of links to key milestones in the compounding saga.
- FDA Approves Abuse-Deterrent Labeling for Reformulated OxyContin, But No More Generics – The agency announced this week that it had approved updated labeling for reformulated OxyContin which has physical and chemical properties to help reduce abuse potential. Moreover, the agency said that since original OxyContin now would pose a higher risk, that the agency has recalculated the risk-benefit consideration and determined that the risks no longer outweigh the benefits and therefore will not be accepting any applications to make original OxyContin in generic form. In addition, FDA provided an updated information page entitled Opioid Medications that outlines agency steps and provides more detailed information about the class.
That’s it for me this week. I hope everyone has a good and safe weekend.