Everyone has returned from vacations and extended vacations and are cramming to get business done before the year end string of holidays. There is been a good deal of activity this week, so let’s get right down to it.
- FDA Establishes Docket For Opioid Feedback – Earlier this month in a posting that tracked the new directions for FDA regarding opioids, one of the items noted was the establishment of an Opioid Policy Steering Committee within FDA. While the operations and impact of the committee were unclear, it comes a little more focused this week when the agency opened a docket to receive public commentary regarding policy options for the agency. Specifically the Federal Register notice states that FDA is looking for input in three key areas: (1) what more can FDA to do ensure that the full range of available information, including possible public health effects, is considered when making opioid-related regulatory decisions? (2) what steps can FDA take with respect to dispensing and packaging (e.g., unit of use) to facilitate consistency of and promote appropriate prescribing practice? and (3) should FDA require some form of mandatory education for health care professionals who prescribe opioid drug products and if so, how should that be implemented. If you are interested in providing commentary, there will be a docket opened at regulations.gov and the docket number to search for will be FDA-2017-N-5608. Also recently posted there was the transcript from the meeting FDA held this summer on opioid policy and that can be found here.
- Breast Cancer Treatment Approval – Verzenio (abemaciclib) won FDA approval this week to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has that has progressed after taking endocrine therapy. FDA noted it is the third drug to be approved in its class and the application has both Priority Review and Breakthrough Therapy designations.
- Glucose Monitoring Device Advancement – FDA announced approval of the first continuous glucose monitoring device which will allow people with diabetes to get needed information regarding glucose readings while reducing the need for fingerstick testing. The device uses a small, self-applied sensor that is inserted below the skin’s surface that measures and monitors glucose levels. An external reader can then determine the glucose levels and how they are changing. The device must be actively checked by the user to determine levels and does not have ability to send an alert on its own and has a 12-hour start up period and can then be worn for up to 10 days. More complete information can be found in the company release here.
- Annual Bust of Online Marketing – FDA announced this week the annual sweep of the Internet of websites engaged in the illegal marketing of prescription drugs. The agency stated that it took action against more than 500 websites that were involved in selling potentially dangerous, unapproved versions of a range of medications that included opioids among others. This was the tenth year of Operation Pangea and is part of the International Internet Week of Action – a cooperative effort of international groups of agencies. Among the action taken, FDA sent 13 Warning Letters to operators of most of the illegal sites and worked to confiscate some websites. In addition, the agency announced that it is also working on a comprehensive Enforcement operations Work Plan to combat the sale of foreign unapproved drugs and to increase the agency’s scope in this effort.
Upcoming Items to Keep an Eye on:
- Senate HELP Committee Hearing on Opioids – Among those scheduled to provide testimony are Dr. Scott Gottlieb, FDA; Dr. Francis Collins, NIH; and Dr. Brenda Fitzgerald, CDC – on October 5 – see details here.
- House Energy and Commerce, Subcommittee on Health – Hearing on October 3 examining patient access to investigational drugs – Commissioner Gottlieb among others to testify – see details here.
- Vaccines AdComm to Meet – On October 4 to consider the flu strains to be included in the next round of vaccine for 2018
That’s it for me this week folks. Enjoy the autumnal weekend.