Well Spring happened. Sorta. At least here in the East the first full day of Spring came with a winter storm warning for several inches of snow. Here in Washington, D.C. this coming weekend marks the beginning of the Cherry Blossom Festival. Not sure how it all works out together. Also this week, Congress sat poised on another budget impasse that would result in a partial shutdown with research funding for NIH threatened and then suddenly an agreement that provides a flow of support for important research across a broad number of categories. Spring and winter, blossoms and snow, cuts and funding.
Sadly another week so busy I did not get to post between Roundups, but that’s the way it goes some weeks. And so here is a bit more of what happened this week:
- FDA Trial Program on Clinical Trial Reports Begins – There has long been a push for greater transparency related to clinical trials for the medicines we take. There has been strong advocacy in Europe and a less, but sustained pressure in the U.S. In January, Commissioner Gottlieb announced that FDA would embark on a pilot program designed to increase transparency, if only incrementally, by releasing more information from clinical study reports (CSRs). While some information has been provided through FDA reviewer summaries of data, which provide information but which are “packaged” in a manner that makes it challenging to digest. As part of the pilot program, FDA committed to publishing redacted company-generated CSRs of 9 volunteer companies. This week, in a blog post published by Center for Drug Evaluation and Research (CDER) head Dr. Janet Woodcock, FDA announced the posting of the first of such data. This first publication of data on FDA’s site comes from Janssen Biotech related to the approval of Erleada (apalutamide), the first FDA-approved treatment non-metastatic, castration-resistant prostate cancer. That leaves 8 more companies. Is it enough transparency or just enough? Time will tell.
- House and Senate Pass Spending Bill – FDA saw increases in funding for fiscal year 2018 in the spending bill that cleared the House this week, with a Senate vote scheduled for today. The funding for FDA included an increase in discretionary funding for the agency of $135 million over last year to $2.9 billion and when user fees are added in the total becomes $5.15 billion. This includes full funding for the Oncology Center for Excellence, additional funding for 21st Century Cures and funding to step up efforts related to the opioid crisis. The House Appropriations release on the funding bill can be found here. There were also increases for NIH funding and a breakout can be found in this detailed reporting from the good folks at RAPS. The House passed the bill on Thursday and the Senate in the earliest hours of Friday morning.
- Flavored Tobacco – FDA is changing the tobacco landscape as we have known it. Last week FDA announced steps to make cigarettes less addictive and this week followed up by beginning the process to make tobacco use less attractive, particularly to youth, by addressing the subject of flavored products, including menthol. The agency issued an Advance Notice of Proposed Rulemaking and will seek input from stakeholders regarding the role that flavored tobacco plays in the initiation of tobacco use as well as its ongoing use and impact on cessation. The effort is particularly focused on youth where flavor reportedly plays a role in starting tobacco use in the first place.
That’s it for me this week folks. Have a good weekend.
Upcoming Events to Keep an Eye on This Week
- March 27 – Psychopharmacologic Drugs Advisory Committee Meeting – to consider NDA for lofexidine hydrochloride for mitigation of symptoms associated with opioid withdrawal
- March 29 – Clinical Chemistry and Clinical Toxicology Panel of the Medical Devices Advisory Committee to discuss application for a device for continuous glucose monitoring system
Regulatory Developments in Pharma/Biotech/Devices
- FDA issues guidance with immediate effect (no public comment) on Compliance Policy for Combination Product Postmarketing Safety Reporting
- FDA extends comment period on drug products labeled as homeopathic