This is it folks, the final stretch. Winter will arrive next week. Travel plans are underway. The last of the gifts are being bought and prepped for the big wrap. And speaking of wrapping up, there are a number of look-backs we’ll be taking in the new year along some specific fronts as the new year begins. But in the meantime, here is a bit of what happened this week:

First “Follow-on” Insulin Approved – In an era where the price of Insulin has continued to rise, FDA approved this week the first insulin product approved through the agency’s abbreviated 505(b)(2) pathway which allows a new drug application to rely on the safety and efficacy data of a previously approved product when FDA finds such reliance scientifically justified. The aim of such a pathway is to reduce development costs and thereby introduce products that can be offered at a lower price. The product Admelog, a short-acting insulin to be used to help patients with diabetes control their blood sugar was approved relying in part on data related to Humalog as well as providing its own specific data to establish safety and efficacy. The company press release can be found here. 

• FDA Launches New Anti-Smoking Campaign – This week FDA announced the launch of a new campaign against smoking that focuses less on scaring smokers with graphic images and relies more on an understanding that quitting smoking is a process, not an event. The campaign uses messages of support to underscore health benefits that come with dropping smoking sent at various points where there may be triggers that faciliate smoking. Called the “Every Try Counts” campaign it will give smoker pause to re-think a purchase of a pack at point of sale locales. Dr. Gottlieb characterized the overall approach in making “cigarettes minimally or non-addictive, while encouraging the development of potentially less harmful tobacco products…” simultaneously taking new steps to improve access and use of nicotine replacement products to help smokers quit. The campaign complements the agency’s plan for nicotine and tobacco regulation. The website for the campaign can be found here. 

Upcoming Events to Keep an Eye on This Week

• Our members of Congress are winding down – no hearings. 
• No upcoming FDA meetings for the balance of the year and no advisory committee meetings scheduled until 2018.

Regulatory Developments in Pharma/Biotech/Devices 

• FDA approves new biosimilar for infliximab
• Generic Viagra launched in U.S. 
• Remarks by Commissioner Gottlieb on Opioid Disposal Options
• Remarks by Commissioner Gottlieb on Therapeutic Nicotine Replacement

That’s it for me this week folks. Have a great and safe weekend. 

Photograph by Lynne Bertram