Weekly Roundup 12.18.15

It is the rush. I am caught wondering how I got here.That situation that every year I say I am going to avoid, but don’t. The one where I am rushing to get everything done before the holiday that needs to be done and feeling overly stressed. The lack of time meant a lack of posting this week, but I shall use the time over the holiday to get a little more on track. In the meantime, it was a busy week an here are a few notes of interest.

  • Future of Research – For the past few years, the future vision of government-sponsored medical research has sometimes been clouded sending advocates to the Hill to try to persuade policy makers not to cut funding. This week two items of significance provide a degree of clarity for the future. First, NIH announced that it was unveiling a 5 year strategic plan – Turning Discovery into Health. The plan outlines a very long list of aspirations that range from new levels of intensity in the battle against cancer, new wearables that will break new ground and new breakthroughs in vaccines and in HIV. And to make that all possible, with Congress poised to pass a new budget deal, funding for NIH would appear to be on track to receive the biggest boost it has gotten in over a decade.
  • Cascade of Approvals Before the Holidays – A lot of people wonder if there isn’t a big rush at the end of the year to get out approvals before the holidays. For those with that point of view, this week provided some food for thought with the announcement of three new approvals. The first was the approval of Bridion to reverse the effects of neuromuscular blocking drugs during surgery – drugs often used during intubation. The agency said that the drug could be used for faster patient recovery after a procedure but also pointed out that some patients experienced bradycardia and raised the concern of some patients experiencing anaphylaxis. News was made this week in both the diabetes and biosimilars worlds with the announcement of the first insulin approval for a follow on product in the abbreviated regulatory pathway set up for this purpose by FDA. Finally there was an approval announced for the first external defibrillator for children at risk of sudden cardiac arrest who are not candidates for an implant. Heretofore, adult devices had to be used off-label.

And for those wondering if in fact there is a year-end growth in approvals – this month has certainly seen a number of such announcements with a total so far of 9 approvals. In December of 2014, there were 17 approvals or expansions of label announced. By contrast, in 2013, there were only 7.

That’s it for me this week. Off to the post office!  Next week has Friday falling on a holiday and the same for the week after, so Eye on FDA will be on a slightly irregular publication schedule getting ready for some themes to explore in the new year. In the meantime, have a fun, safe and happy holiday season.

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