Today marks the beginning of autumn and the summer of 2017 is over. The first turning of trees has begun and leaves and acorns are dropping on lawns. The linens have left our closets and we are beginning to think about getting all of the sweaters organized and cleaned. And most certainly, the days grow shorter. Meanwhile, as we ready ourselves to shift gears, here is a bit of what happened this week – and a new feature I would like to add – what to look for in the coming days.
- A Report and a Meeting on Antibiotics – Two items of note this week on antibiotics. First the World Health Organization issued a report stating that the world was “running out” of antibiotics and that the current pipeline offered only modifications of existing medicines while we face the development of resistant strains of infection, particularly in tuberculosis. WHO calls on the pharmaceutical industry to focus on new antibiotic development. And also this week, FDA announced the 2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System to be held on October 24-25. For those interested in participating, you must pre-register by October 10. The docket will remain open for public comment until November 24.
- FDA Statement on Medication Assisted Treatment (MAT) for Opioid Addiction – The Commissioner issued a statement yesterday regarding FDA’s efforts to support treatment for opioid addiction through medication assisted therapy – the use of medication combined with behavior therapy, where he reiterated that addressing the opioid epidemic was his “highest public health priority”. The statement highlighted the release by FDA of a Drug Safety Communication regarding MAT used in patients who are also receiving therapies where there could be a heightened potential for adverse events, and underscores the priority of treating addiction. This risk/benefit assessment is an example of weighing two risks – one involving untreated addiction and the other an adverse event caused by drug combinations – and setting a priority.
- FDA Advisory Committee Splits on Recommendation – The Oncologic Drugs Advisory Committee delivered a 6-6 vote this week after considering the risk/benefit profile of SUTENT® (sunitinib), a proposed adjuvant treatment for patients who have a high risk of cancer recurrence following surgical removal of a cancerous kidney as part of a sNDA submission. SUTENT was first approved in the U.S. in 2006 for the treatment of advanced renal cell carcinoma and has indications for GIST and advanced pancreatic neuroendocrine tumors. The company stated that an FDA decision is expected by January 2018.
- Upcoming Meetings This Month
- Peripheral and Central Nervous System Drugs Advisory Committee will meet September 28 to discuss new drug application for ataluren for oral suspension, sponsored by PTC Therapeutics, Inc. for the treatment of patients with dystrophinopathy due to a nonsense mutation in the dystrophin gene. Meeting materials will be located here.
- Senate HELP Committee Hearing on Opioids – Among those scheduled to offer testimony are Dr. Scott Gottlieb, FDA Commissioner, Dr. Francis Collins, NIH and Dr. Brenda Fitzgerald of CDC – on October 5 – see details here.