Weekly Roundup 9-2-16

The end of summer.

This is less like a Weekly Roundup than a Monthly Roundup. Like everyone else, I have taken August with a grain of salt. It feels a little lonely writing blog postings when you know that readers have headed out to beaches and mountains and are getting much deserved rest and relaxation. So I got a little in too.

Still, things happened, and here we are at the cusp of the Labor Day Weekend when we slip out of summer and for this year – fully into the election cycle. So here are a few of the interesting items of note.

  • FDA Ups the Warnings on Opioids – The agency announced class-wide changes to safety requirements for prescription opioid analgesics, cough medicines containing opioids, and benzodiazapines – both classes of drugs that are central nervous system depressants – to warn that combined use of these products pose serious risk, including extreme sleepiness, respiratory depression, coma and death. The new measures will include a boxed warning on products (over 400 by FDA’s count) as well as Medication Guides. FDA said that the announced label changes were part of its ongoing Opioids Action Plan.
  • FDA Revises Recommendation on Zika Blood Screening – In February FDA issued curious guidance recommending that only blood and blood products collected in geographical areas where there is an active Zika outbreak be screened for Zika. This week the inevitable occurred with the agency announcing a revision of the earlier guidance to include all blood and blood products in the United States for purposes of screening.
  • FDA to Hold Public Discussion About Unapproved Use Communications – The agency announced this week that it would be holding a two-day public meeting to get input on the subject communication by manufacturers of unapproved uses for drugs, biologics and devices. The meeting will be held November 9 and 10 and those wishing to provide comment at the meeting are directed by FDA to register by October 19 with electronic comments being accepted until January 9, 2017. The meeting will be held at the FDA facility in Silver Spring. More information can be found in the Federal Register announcement located here.

That’s it for me this week folks. I hope you had a good summer. Time to get out the books and get back to work. I’ll do that next week. Have a wonderful weekend.

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