As we ease into the new year cycle, 2018 is still waking up. Many of FDA’s web pages are not yet updated to reflect that the new year even exists. The weather is erratic, with low low temperatures one day and rather high a few days later. The flu season is flourishing. Comfort food is a good idea. But if you are not cold and not hot and not sick, here are a few of the things that were of interest this week. 

• FDA Takes Action on Cough and Cold Meds with Opioids – In another in a growing list of actions taken by FDA to address some aspect of the opioid epidemic, the agency announced this week that it was moving to require safety label changes to prescription cough and cold opioid medicines containing codiene or hydrocodone so that (1) they be labeled only for use in adults aged 18 years and older and (2) have additional safety information for adult use, including an expanded Boxed Warning. For the under-18 population, the agency stated that the risks no longer outweigh the potential benefits. 

• AdComm Votes on Testosterone Replacement Therapies – The Bone, Reproductive and Urologic Drugs Advisory Committee met for two days this week to consider NDAs for two testosterone replacement therapies.  On January 9 and 10, the committee met to consider two separate applications for oral testosterone undecanoate capsules – for the proposed indication of testosterone replacement in males for conditions associated with a deficiency or absense of endogenous testosterone: Primary hypogonadism, congenital or acquired, and hypogonadotropic hypogonadism, congenital or acquired. Neither got an approval recommendation from the committee with the first drug Jatenzo getting a nearly split 9 Yes/10 No vote and the following day Tlando seeing a 6 Yes/3 NO vote against approval.  

• AdComm Votes for NCFB Treatment – In a separate meeting of the Antimicrobial Drugs Advisory Committee there was evaluation of another compound, this one to treat Non-Cystic Fibrosis Bronchiectasis. The vote was 12 No/3 Yes/1 abstain in response to the ultimate question of the demonstration of safety and efficacy. The company said in its release that the action date would be January 26.  As with all advisory committee outcomes, FDA is not obliged to follow the recommendation of its committees.  This makes an AdComm track record for 2018 at 0/3. 

That’s it for me this week folks. Have a good, long weekend. 

Upcoming Events to Keep an Eye on This Week

• Senate HELP Committee – January 17, 2018 – “Facing 21st Century Public Health Threats: Our Nation’s Preparedness and Response Capabilities”, Part 1 – Panel to include Commissioner Gottlieb, among others. 

Regulatory Developments in Pharma/Biotech/Devices

• Breakthrough Therapy Designation for Eisai and Merck in Combination Therapy for Advanced and/or Metastatic Renal Cell Carcinoma 
• Sickle Cell Candidate Gets Breakthrough Therapy Status 

Photograph Courtesy of Lynne Bertram