Weekly Roundup 8.3.18

This week’s posting about FDA Communications resulted in a nice story by Ed Silverman over at STAT and some Twitter action from the Commissioner about the role of the “Statement from FDA Commissioner” missives that I wrote about. Fun stuff.  – On other fronts, as mentioned last week, I have been a little out of commission due to some personal things, but am back with my eye on things. Here is a bit of what I thought noteworthy from this week.

  • REMS Review – Dr. Gottlieb remarked via a statement  on the meeting (held August 3) of the Anesthetic and Analgesic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee would be meeting to review the assessments of REMS programs, which were first approved in 2011, related to the use of transmucosal immediate release fentanyl (TIRF) products. The end goal is to determine whether or not adjustments to the elements of the program are necessary.  The statement reaffirms the often expressed aim to strike a balance between the need for appropriate access versus potential for abuse. One focus of the meeting, he said, will be not only an examination of the data, but the accuracy of data, related to prescriptions of TIRF medications for patients who are non-opioid tolerant. For those interested not only in the issue of appropriate use of opioids for pain control, and the issue of misuse, but also those interested in how such data is accurately harvested, it should be an interesting meeting. 
  • Warning in Women’s Health – Another statement from the Commissioner this week focused on a warning issued by the agency regarding the use of devices for “vaginal reconstruction” to treat conditions related to menopause, sexual function and urinary incontinence.  The agency said that energy-based devices – commonly referred to as radiofrequency or laser – which have approval for specific conditions have been marketed for a non-approved use under the heading of vaginal reconstruction. The agency issued the warning for women and their doctors and notified seven manufacturers regarding the inappropriate marketing of devices. 
  • House Energy and Commerce Letter to Opioid Manufacturers – This week the House Energy and Commerce Subcommittee on Oversight and Investigations sent a letter to three manufacturers of opioid products.  The committee site excerpts from the letters states “For more than a year, the Committee has been investigating the potential breakdowns in the controlled substances supply chain which may have contributed to the nation’s opioid epidemic. Pharmaceutical manufacturers play a unique and critical role in this supply chain by researching and developing products for the consumer market as well as marketing such products after obtaining approval from the Food and Drug Administration (FDA)”. In short, the letters are seeking information, and pose a series of questions, aimed at gaining insight into marketing practices and awareness of misuse. 

Things to Keep an Eye on This Week

  • Senate not in session. 
  • August 7 – Antimicrobial Drugs Advisory Committee – meeting to consider NDA for amikacin liposome inhalation suspension for proposed indication of mycobacterial lung disease. 

Regulatory Developments in Pharma/Biotech/Devices

Photo this week by me!


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