Soon school will be out, rush hour will be less hectic, vacations long planned will be taken. Pollen counts are high and thunderstorms threaten to materialize nearly every other day. Washington is moving at high speed though the gravity of politics outweighs that of policy by far. In the meantime, here is some of what happened this week and some to look forward to next week in this Weekly Roundup.
- FDA Moves on Stem Cell Clinics – The agency announced this week that it was seeking permanent injunctions against two stem cell clinics marketing unapproved stem cell products to patients – one in Florida and one in California. FDA found that the clinics were offering treatment for a wide variety of conditions including Parkinson’s disease, AML, COPD, cystic fibrosis among others. FDA is seeking permanent injunctions against the clinics. Stem cell operations offering hope to patients with life-threatening conditions are not a new phenomenon. And the number of practitioners is high – as evidenced in this 2016 survey published in Cell Stem Cell. While FDA’s action is aimed at only two, it begs the larger question about the operations of many other clinics in the U.S.
- Non-surgical Device for GI Bleeds Approved – FDA approved a non-surgical treatment for upper (esophagus, stomach and small intestine) and lower (large intestine and rectum) bleeds of the gastrointestinal tract the agency announced this week. The treatment is an aerosolized spray delivered during an endoscopic procedure and is not intended for use in all kinds of bleeds, including for patients with bleeds derived from large veins developed as a result of conditions such as alcoholic liver disease. The spray is a device that was approved under FDA’s De Novo pathway, a risk-based classification for devices without a predicate device already on the market and which is regarded to present low to moderate risk. The company release can be found here.
- More Action on e-Liquids – Following up on prior action against marketers, FDA this week announced four new warning letters aimed at manufacturers selling “e-liquids” – that which goes into an e-cigarette and contains nicotine – in a way that makes the product resemble products designed for children such as soda, cereal and pancakes. In addition one of the manufacturers was cited for selling such products directly to minors. In the announcement about the action, FDA made the point that apart from presenting a danger to minors, such marketing techniques undermine the legitimate potential role for e-cigarettes to support tobacco cessation by adults. It was unclear from the release if this action is part of a continuing string designed to inhibit such marketing practices or if the letters of the past two weeks are meant to address the entire scope of the problem. The manufacturers have 15 days to respond to the warning letters.
Things to Keep an Eye on This Week
- May 15 – Senate HELP Committee Hearing – Examining Oversight Reports on the 340b Drug Pricing Program
- May 17 – Vaccines and Related Biologics Products Advisory Committee – Approaches to Group B Streptococcus Vaccines in Pregnant Women
Regulatory Developments in Pharma/Biotech/Devices
- Spring Unified Agenda: FDA’s Anticipated Upcoming Regulatory Work
- FDA Letter Denying Petition to Block Generic Applications for Advair