Weekly Roundup 8.11.17

I’ve decided to bring back the Weekly Roundup. I have missed it and especially now with the prospect of a good deal of change in healthcare in general and FDA in particular, much more is happening than I would ever have time to write about in regular every day blog postings. ¬†The Roundup affords an opportunity to take note of some milestones that are either interesting or should provoke some thought for stakeholders in healthcare. I strayed, but now return – back in the saddle.

And so here is a bit of what happened this week that was noteworthy:

  • New ALS Drug to Market - During the last week of July, award winning playwright, actor and director Sam Shepard died of complications from amyotrohphic lateral sclerosis (ALS), also known as Lou Gehrig’s Disease. This week the first new drug in more than twenty years, Radicava (edaravone) became available for patients following the May 5 approval by FDA. ALS is a degenerative disease of the nerve cells that control voluntary functions of the body and is estimated to affect 12,000-15,000 people in the U.S. ¬†Radicava is an intravenous treatment and according to the company’s multimedia news release can be administered in a number of infusion settings.
  • Expansion of FDA’s Tobacco Education Campaign - The Real Cost campaign was launched by FDA in February ¬†2014 aimed at youth who were smoking or trying to quit smoking and has developed an array of resources to support it. Employing multiple media platforms, including social and traditional, FDA points to follow up research that demonstrates that the first two years of the campaign resulted in a significant decrease in young people taking up smoking, or quitting once they had. This week the agency announced an expansion of the campaign to now include e-cigarettes, citing estimates that the number of middle and high school students who have become users. The agency said that the expanded campaign was part of a comprehensive plan aimed at tobacco announced in late July.
  • FDA to Hold Public Meeting on Risk/Benefit – The agency announced this week a public meeting to be held on September 18, 2017 for the purpose of discussing topics related to structured assessment of benefits and risks in drug regulatory decision-making. Among other things, the meeting will focus on approaches to incorporating patient perspectives as well as methods to structured benefit risk assessment. The format will be comprised of a number of presentations and panels. Registration deadline is September 11 and the agency has set up a docket for comments at regulations.gov. For those considering attending, the meeting is to be held at the FDA’s campus in Silver Spring (which means go early and wear comfortable shoes).

That’s it for me this week. I hope you enjoy the return of the Weekly Roundup and have a good weekend.

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