The leaves are falling around us and still no first frost. And we are just a few short days from the knocks at the door by young and sometimes not so young seeking sugar handouts while dressed in costume. If you don’t have your candy in hand, better run to the store. Before you do – a few things that happened this week:
- FDA Issues Draft Guidance for “Breakthrough Devices – This week the agency published in the Federal Register a draft guidance to enhance the regulatory approval for breakthrough devices. As with breakthrough status designation for drugs already in existence, FDA is seeking to enhance the approval of devices, however, the status for devices differs from that of drugs in important respects. The particulars of the program as described in the draft guidance are detailed by the Regulatory Affairs Professional Society. In short, while allowing for an enhanced pathway to approval, it is not a guarantee of faster approval. In addition, Commissioner Gottlieb released a statement respecting the development of a new medical device evaluation tool for use in cardiovascular devices that ties patient output with device development as part of the FDA’s Medical Innovation Access Plan.
- Duchenne Treatment Candidate Gets Complete Response Letter – Last year the agency gave accelerated approval to a drug for use to treat a subset of patients with Duchenne muscular dystrophy and earlier this year another that could be more broadly applied. However, this week in issuing a complete response letter for another candidate treatment – one that would treat patients with Duchenne due to a nonsense mutation in the dystrophin gene, FDA said that the compound needed further evidence of efficacy which reflected some of the input from the FDA Advisory Committee held earlier this year. In a statement, the sponsor has said that an appeal to the decision will be filed. The webcast and meeting minutes from the advisory committee meeting can be found here, though the transcript is not yet posted.
- Opioid Public Health Emergency Declared – A long-anticipated announcement by the White House declaring the opioid epidemic a public health emergency was announced this week. The measure opens up the way for government agencies to work to take measures to address the spectrum of complex issues that make up the epidemic, but fell short of the expectations of many to provide new funding for states. Last week in a panel discussion at the Washington Post called Addiction in America, Senators Portman, Hassan and Manchin expressed the hope that the declaration would bring with it additional funding. In addition, Commissioner Gottlieb issued a statement from FDA outlining the steps the agency has been taking on opioids.
Upcoming Events to Keep an Eye on This Week
- Joint Meeting of Psychopharmacologic Drugs AdComm with Drug Safety and Risk Management – On October 31st to discuss NDA for new treatment for opioid dependence. Meeting again on November 1 to discuss a second NDA for the same indication.
- Antimicrobial Drugs Advisory Committee – On November 16 to discuss NDA for ciprofloxacin inhalation powder for reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) in patients with respiratory bacterial pathogens.
Regulatory Developments in Pharma/Biotech/Devices
- FDA Breakthrough Status for Melanoma Investigative Compound
- Very Nice Roundup of Digital Device Clearances for 3rd Quarter (mobihealthnews)
Photograph by Lynne Bertram, Woodstock, Vermont