The vacation continues here in Washington, D.C. Traffic is lighter than a feather. Heat and thunderstorms continue and some of the leaves on trees have had it and are falling early, not in autumnal fashion, but as dried up little tired things – perhaps they were the earliest to appear in Spring and are now calling it a season. Tomatoes are still in their full glory which coincides nicely with bumper crops of basil. In the meantime, there was a little official life going on and here is some of it:
- FDA Pronouncement on Opioids and Animal Care – Commissioner Gottlieb released a statement this week addressing the agency’s ongoing efforts to curb abuses in opioids but this time in relation to veterinary medicine. FDA produced a new resource to inform vets regarding potential abuse by humans with pets, designed to provide context around possible diversion by humans who are exploiting an animal in order to obtain opioids. The agency is recommending the use of alternatives to opioids where appropriate and advising vets on the development of plans should they encounter a situation where there is suspected diversion. The resource, however, refers vets to local police for information and does not provide a blueprint, guide or considerations for development of such a plan.
- EpiPen Generic Approved – As headlines appeared regarding an Epipen shortage, FDA this week approved a generic version of the combination product auto-injector of epinephrine for use in the emergency treatment of allergic reactions. While FDA does not have authority over pricing of the products it regulates, the approval and introduction into the marketplace is one means by which FDA may influence pricing. According to the agency’s press release, this is the first approval of a generic version of the most widely prescribed epinephrine auto-injector in the US.. He added that the agency is committed to the development of generics, particularly of hard-to-copy products and would be advancing new guidance in this space as well as prioritizing review of generic applications. Last year FDA approved a record number of generic drug applications.
- FDA, NIH on Modernizing Gene Therapy – In the wake of the approvals of the first three gene therapy treatments by FDA this year, the heads of FDA and NIH announced reforms to the review of gene therapy research designed to maintain safety while streamlining overnight, a regulatory reform theme during the past two years. Drs. Gottlieb and Collins stated that they would seek to reduce duplicative reporting requirements made by their agencies on research and that NIH would be dropping several of its review procedures though research will continue to be subject to FDA clinical trial regulations. To provide more thorough context and history regarding the gene therapy research and regulation, the pair published an article in the New England Journal of Medicine.
Things to Keep an Eye on This Week
- August 23 – Senate HELP Committee Hearing – Prioritizing Cures – Science and Stewardship at the National Institutes of Health
- No new FDA AdComms to report
Regulatory Developments in Pharma/Biotech/Devices
- Voluntary Recall of 2 Thyroid Medications for Impurities
- FDA Sets AdComm for Flu Vaccines Review for 2019
- FDA Streamlines Procedure for Reporting Device Malfunctions