Weekly Roundups have been in absentia for the past few weeks. Forgive me – it has not been for lack of wanting to get the job done, just time. May began with a serious bout of the flu. While it only had me down a week, there was a lot of catching up, among other things. Even today, the Roundup comes on a Saturday. Moving forward, I will try to be more assiduous.
Given the lapse, I thought I would turn our attention to a few things that happened of note, both this week and in the last few (to cover for some lost time):
- FDA Makes Big Move on Nicotine – You would have to be living under a rock, or have a serious bout of flu, to have missed FDA’s action on tobacco announced early in the month. But just in case you missed the deets, here is a synopsis. First, the agency extended its authority over tobacco to include e-cigarettes, cigars, hookahs and pipe tobacco among others and such products cannot be sold by vending machine nor can samples be given. Second e-cigs will no longer be sold to persons under the age of 18 years. Third, the agency said that newly regulated products will have to be reviewed by FDA and that manufacturers will have to file an application with the agency for consideration so that the agency can review ingredients, health safety and whether or not the product appeals to young people. Products that are already on the market will be given continued market time for a period as time to prepare. In short, the pathway from teen to adult nicotine access narrowed significantly.
- Flurry of Activity Around Compassionate Use– Leaving many to wonder if there was not a point given the timing to it with regard to an upcoming FDA decision in treatment for Duchenne Muscular Dystrophy, during the first week of June FDA released several guidance documents around compassionate use. Released were a Guidance on Individual Patient Access Applications, a Q&A on Expanded Access to Investigational Drugs for Treatment Use, and Q&A on Charging for Investigational Drugs under Investigational New Drug Applications. A statement released on the subject from the FDA Commissioner shed no light on the reason for the series of releases but media reports on the subject matter had FDA denying there was a link between the timing and the consideration of any particular NDA.
- Advances in Detection of Two Different Cancers – June began with the approval of two cancer detection methods for different types of cancers. First as cancer treatments become more and more focused on the type of cancer a patient is facing, the agency announced that a blood test was approved to determine whether or not an important gene mutation exists related to non-small cell lung cancer (NSCLC). The approval means that a treating physician can initially conduct a blood test, as opposed to biopsy, to determine the presence of a particular gene mutation that would be indicative of appropriate treatment. The same day, the agency announced approval of a new diagnostic imaging agent that can be used to detect rare neuroendocrine tumors. The approval had priority status and orphan drug designation.
- Food Labels are Overhauled – In a long-awaited move, the agency announced revisions to the labels that we read when standing in the grocery aisle trying to decide whether to make a purchase (often while others are trying to get by us). While there area many changes coming to the label, to that end, two stand out. First the agency is making changes to highlight the information around the number of calories and the number of servings contained in a product, but more pointedly, the agency is making a concerted effort to point up the sugar content in the product. The date slated for the change for most manufacturers is July 26, 2018.
That’s it for me folks. Hopefully back in the saddle here. Hope you have a good weekend.