Greetings to you from Cape Cod. A little vacay time. And it was a good time to get out of Washington, D.C. as you may have noticed. Lots happening, challenging to any other news that might emerge during this time. Still, there may not have been dramatic televised daytime hearings, but some things did happen in our corner of the world and here are a few of them.
- Gottlieb Opens Flu Season – The flu season started this week and FDA Commissioner Gottlieb issued one of his many statements on the topic – and in fact, I know of some people who began the season early. He noted that the flu virus is a vaccination challenge given that the viruses can not only change from season to season, but during the season and that while during last year’s flu season there were less than optimal experiences with the efficacy of last year’s vaccine in the face of a season that had a high level of severity, it is nevertheless important (he got his flu shot for this year). Last year, for example, the strains identified for the vaccine were correct, but some changes in the makeup of the strains over time caused the vaccine to be less effective than in years past. He believes that there have been updates to the scientific approach taken to address these changes that reduce the chances of a repeat of last year’s issues. He dove into an extraordinary amount of detail regarding how flu vaccines are manufactured, but his bottom line is that vaccination remains the square root of effective flu season preparation.
- FDA New Draft Guidance on Adaptive Designs – FDA this week brought out two draft guidance documents designed to facilitate the development of clinical trials that examine multiple drugs for multiple issues and therefore establish principles moving forward more quickly than can be accomplished through a singular and sequential model of study.In FDA’s statement on the guidelines, Dr. Gottlieb stated that improving the approaches to drug development in this manner could speed up the discovery and development of new therapies, not only getting them into the hands of physicians and patients more quickly, but creating an environment with a greater potential for competition of compounds thereby bringing prices – as well as the cost of development – down. The two drafts “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biosimilars” and “Adaptive Designs for Clinical Trials of Drugs and Biologics” were reported in the Federal Register and more can be seen in that publication here and here regarding the docket that is being opened offering the opportunity for public comment.
- NSCLC Approval – In the past few years, there have been a number of advances in oncology, both blood-based cancers and solid tumors, reflected in the large number of approvals that have come through. This week FDA approved a new first-line oral, once daily treatment – a kinase inhibitor – for Non-Small Cell Lung Cancer (NSCLC) with three unique biomarker properties. Vizimpro (dacomitinib), per the company press release, the FDA had granted a priority review.
- DEA Re-Schedules Epilepsy Treatment Derived from Marijuna Plant– In 2015, legislation was signed into law that set a timeframe for the Drug Enforcement Agency to take action on scheduling drugs that had been approved by FDA. This week DEA issued an order for scheduling a recently FDA approved plant-derived cannabidiol treatment for epilepsy listing it under Schedule V which is the lowest restriction level, meaning there is a proven medical use and a low abuse potential. The re-scheduling affects only one FDA-approved treatment and per the company release, all other non-FDA approved cannabidiol treatments are in Schedule 1. The company said in its release that with the completion of the label, it hopes to make the medicine available in six weeks.
Things to Keep and Eye on This Week
- October 3 – Senate HELP Committee, Subcommittee on Children and Families – Hearing – Rare Diseases: Expediting Treatments for Patients
- October 3 – Vaccines and Related Biological Products Advisory Committee Meeting – 2019 Influenza Vaccine Strains
Regulatory Developments in Pharma/Biotech/Devices
- FDA issues draft guidance on Special 510(k) program
- Lilly gets approval of migraine prevention treatment
- FDA Re-classifies and Re-names “Female Condom”
- Once daily oral treatment for NSCLC approved