This is it. We are in the home stretch. Summer, at least the one defined by the school year, is almost over. Even though it is many years for me that I have been ruled by that calendar, it will always be the one most real for me. So even though Summer officially ends much later in September, really, this is it. We get one more week of respite from traffic before the Labor Day weekend signals the return to regular routine. And even though it is a time that is less productive than other parts of the year, here are a few things that happened this week of note.
- FDA Announces Effort to Devise a Framework for Opioid Guidelines – The Commissioner issued a statement this week announcing that the agency has awarded a contract to the National Academies of Sciences, Engineering, and Medicine (NASEM) to assess the evidence that would be needed to inform future clinical practice guidelines for opioid analgesic prescribing are sufficient and to identify the research necessary to generate needed evidence. The scope of the work includes the commencement of a consensus study to identify where evidence-based clinical practice guidelines would best inform prescribers as well as a gap analysis of existing guidelines by, among other things, conducting a series of meetings and public workshops to engage contributing stakeholders in the analysis.
- First Drug Approval for Rare Disease of the Cornea – Oxervate (cenegermin) won approval from FDA this week for the treatment of neurotrophic keratitis, a condition affecting the cornea in less than five in 10,000 individuals. It is, however, a degenerative disease that has a huge impact on the patient resulting in the loss of corneal sensation and progressive damage that in turn can mean thinning of the cornea, ulceration and perforation. Until now, treatment was palliative and involved surgery. Oxervate, a first-in-class recombinant human nerve growth factors, is a topical eye drop and is the first topical biologic approved in ophthalmology. Oxervate was a Priority Review, with Orphan Drug Designation, Fast Track and Breakthrough Therapy Designation. The company release can be found here.
- FDA Extends Expiration Date on EpiPen – In the face of reported shortages for EpiPen and coincident with back-to-school time, FDA announced this week that it was extending the expiration date of some lots of the product by a period of four months and has put up a web page where consumers can check the numbers of the batches for dates. While it brings some relief to the shortage, along with the recent approval of a generic demonstrates the types of actions FDA can take to impact the status quo with regard to both supply and price. It also leads one to wonder what are the criteria for deciding what dates can be extended and how much wiggle room there is around a stated expiration date.
Things to Keep an Eye on This Week
- August 29 – Senate HELP Committee Hearing – FDA Oversight: Leveraging Cutting-Edge Science and Protecting Public Health (Commissioner Gottlieb is sole witness)
- September 4 – Public Hearing – Facilitating Price Competition and Innovation in the Biological Products Marketplace
Regulatory Developments in Pharma/Biotech/Devices
- FDA Adds Four Tropical Diseases to Priority Review Voucher Program to Encourage Development
- FDA Issues Draft Guidance – Hematologic Malignancy and Oncologic Disease – Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development
- FDA Issues Draft Guidance – Osteoarthritis – Structural Endpoint for the Development of Drugs, Devices and Biologics