We have no sooner gotten rid of the candy from Halloween then we are preparing to receive our Thanksgiving guests and putting together menus for the big day, only to rush headlong into the next holiday season that will involve a crescendo of preparation! Our days are darker earlier and soon we shall slow down to a crawl. And in fact, Eye on FDA will be on hiatus until after the Thanksgiving holiday. But before that, here is a bit of what happened this week.
- Big Day for Regenerative Therapy – Since in office Scott Gottlieb has announced multiple initiatives aimed at enhancing the development of new therapies – in the past few months in devices – and this week with the issuance of multiple guidance documents – in regenerative therapies. Two guidances in particular shed light on FDA’s risk-based approach for regulating regenerative therapies, providing categories into which therapies may fall and therefore receive varying degrees of regulatory oversight. In total there are two new guidance documents and two new draft guidances which provide insight into how regenerative approaches can take advantage of a streamlined application process and another on getting expedited reviews. The framework brings clarification on a comprehensive scale.
- First Device for Opioid Withdrawal – FDA announced approval of the first device intended to ease opioid withdrawal symptoms. The device, called the NSS-2 Bridge, is a small electrical nerve stimulator that is placed behind the patient’s ear, emitting stimulative pulses to some cranial nerves to address symptoms of withdrawal such as sweating, gastrointestinal upset, agitation, insomnia and joint pain, and can be work for five days. The approval was based on a single study which showed that all patients had a reduction of symptoms within a half hour of use. Information from the manufacturer can be found here. The approval happens in a week when there was also publication of a head to head study of two medicines approved for opioid addiction treatment.
- Two Warnings from FDA – The agency issued two unrelated public safety communications this week. The first was related to the use of silicone injected as a dermal filler for cosmetic purposes (different from approved silicone implants). The agency noted that in some cases industrial grade silicon was being used and said any silicone injections for this purpose, often by unlicensed practitioners, were an unapproved use and could result in serious adverse events. The other public health alert was issued to address concerns related to the use of kratom, a plant being imported and marketed for use in treating anxiety and depression and opioid addiction. The agency warned of very specific risks associated with the use of the plant, including liver toxicity.
Upcoming Events to Keep an Eye On
Next week being Thanksgiving Week, there are no FDA scheduled events and you can bet Members of Congress are not sticking around. Here are a few things thereafter though:
- Public Meeting on Assessment of FDA Hiring and Retention – On November 30, FDA is holding a public meeting to share findings of a recent assessment on FDA’s hiring process.
- Bone, Reproductive and Urologic Drugs Advisory Committee Meeting – On December 7, to discuss patient selection criteria and clinical design features for drugs to treat interstitial cystitis and bladder pain syndrome as well as a discussion of the two conditions.
Regulatory Developments in Pharma/Biotech/Devices
- FDA Expands Label of Sutent to Reduce Risk of Kidney Cancer Return
- Remarks by Commissioner Gottlieb at FDA Office of Criminal Investigation Meeting
- FDA Grants Expedited Pathway for Medical Device – a Coritcal Visual Prosthesis System
For US readers – have a wonderful Thanksgiving – everyone else have a great weekend.
Photograph by Lynne Bertram