We are already arriving at Columbus Day Weekend. The year has gone by breathtakingly fast from my perspective. We are only a month away from changing the clocks, but it will be here before you know it. I am already craving the comfort foods of winter. In the meantime, here is a bit of what happened during our speedy week – and a quick reminder that Monday is a federal holiday.
No Love for FDA – In what has become a widely reported transmission from FDA, the agency this week posted a warning to a food manufacturer that included, among other things, an admonishment about an unusual ingredient listed in the label. Specifically, FDA concerned itself that included in a label for granola, the manufacturer had included the word "love" to which FDA registered disapproval. "Ingredients required to be declared on the label or labeling of food must be listed by their common or usual name…Love is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient." Golly FDA reviewer, I don't know about your household, but in mine love is quite a common ingredient. This quite literal exercise in enforcement led to a lot of coverage respecting the letter, more than would be usual. While the letter addressed many items, the issue of the ingredient of love was the part that was widely reported which makes an interesting learning lesson in and of itself.
First Zika Test Approved for Blood System – The agency announced the approval of the first assay to screen donated blood and blood components for the Zika virus – and not meant for use in testing or screening individuals. Up to this point, blood screening was being done utilizing a screening test under investigative review in order to comply with FDA's guidance for screening issued in August 2016 in response to the widening exposure of Zika in the U.S.
Access to Investigational Drugs Testimony – Recalling his own experience as a cancer patient and taking off-label treatment, Commissioner Gottlieb spoke before a House Energy and Commerce, Subcommittee on Health hearing this week on early access to investigational drugs. He stated that in recent years the agency had received over 1000 applications for early access to investigational drugs and that 99 percent of those applications were granted and that the processing was very quick and had in fact been streamlined this past year. He also said that FDA was working with NIH to provide patient advocacy groups with more information about expanded access and had launched a tool for patients to get more information online as well as addressing concerns raised in a recent GAO report regarding adverse events associated with expanded access. Finally he addressed issues associated with proposed "right to try" legislation before the Senate.
That's it for me this long weekend. Have a good one folks and be well.
Patient Engagement Advisory Committee Meeting – The meeting will be October 11 and 12 and the topic will be the subject of patient input into the clinical trials for devices. More information can be found here.
Cellular, Tissue and Gene Therapy Advisory Committee Meeting – The committee will meet to consider a BLA for a new therapy for a type of retinal dystrophy on October 13. More information can be found here.
Dermatologic and Ophthalmic Drugs Advisory Committee Meeting – The committee will meet to consider the NDA for a new therapy for reducing intraocular pressure in patients with glaucoma or ocular hypertension. More information can be found here.
International Conference on Viral Hepatitis – Chicago, Illinois October 9-10 – for more information, visit here.
Senate HELP Committee Hearing – October 17, Part II on The Cost of Prescription Drugs: How the Drug Delivery System Affects What Patients Pay – check it out here.