The funding kerfuffle came and went. Order was restored to the universe after a brief blip shuttered federal agencies, FDA among them, for a single work day. It almost seems like a distant memory already, until next time. The weather has returned to its global warming trend with unwintery temperatures. Not only has FDA been open for business, but there is a lot of stuff coming up. Here is a bit of what happened this week that you may wish to know about.
- OPDP Issues 5th Letter of the Year – The Office of Prescription Drug Promotion (OPDP) may have surprised many by posting the fifth, and presumably final, letter issued by that office for the year 2017. An untitled letter, the violation was promotion of an unapproved product and the communications vehicles involved were a website and a brochure. In 2016, OPDP had also issued some letters for unapproved product promotion which up until then, had been a comparatively rare violation. By my count, there have been only 14 letters since 2010 involving this violation (for 15 violations), 4 of which were in 2016. The most recent involved statements made on a website and in a brochure regarding safety and effectiveness of an investigative agent.
- FDA/FTC Warn on Unapproved Opioid Cessation Products – A joint set of warnings were issued by FDA and FTC this week to twelve marketers/distributors of products with thereapeutic claims of efficacy in opioid cessation without approval. The list of claims involved in the product promotion ranged from “Safe and effective natural supplements that work to ease many physical symptoms of opioid withdrawal” to “Break the Painkiller Habit”. In addition, FTC issued a fact sheet with information on accessing the right help for opioid addiction. Prior to this action, FDA has taken several steps to address various aspects of the opioid epidemic, including approval of new medication-assisted treatments.
- FDA AdComm Burns Modified Risk Tobacco Product – Sorry I couldn’t resist the headline. The Tobacco Products Scientific Advisory Committee met this week to consider an application DOE modified risk tobacco product. Three variations of “Heatsticks” – a mechanism that heats but does not burn tobacco, referred to as IQOS- were discussed and first considered were claims that the manufacturer sought for the products. According to published reports (transcript or minutes are not yet available), the claims that were sought stating that the product would reduce the risks of tobacco related disease and that the products presents less risk of harm to the user than traditional tobacco smoking and both were voted down by the committee and ultimately did not recommend approval by FDA.
Upcoming Events to Keep an Eye on This Week
- FDA Public Workshop – January 29, 2018 – Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology
- Senate HELP Committee, Subcommittee on Primary Health and Retirement Security Hearing on Tuesday, January 30, 2018 – Roundtable on Small Business Plans
- House Energy and Commerce, January 30, 2018 – Examining Implementation of Compounding Quality Act
- FDA Public Workshop – January 30-31, 2018 – Fostering Digital Health Innovation: Developing the Software Precertification Program
- FDA/International Society of Pharmaceuticals Workshop – February 1, 2018 – Model Informed Drug Development for Oncology Products
Regulatory Developments in Pharma/Biotech/Devices