Weekly Roundup 9.16.16

Kids are back in school. The air is kinder, gentler and less harsh than the last heated days of summer, though summer tries to hang on some days, it is ebbing into Autumn. Halloween candy has already appeared in stores.

There was no Weekly Roundup last week, so some of what is included this week laps over. Here is a bit of what happened while we transition the season.

  • OPDP Sends Out Letters! – After a long period of lethargy on the enforcement front, in the past few weeks FDA has sent out 2 enforcement letters which literally doubles the number sent so far this year. Between the two, an op-ed I wrote for The Hill appeared about the lack of enforcement – timing is everything. Interestingly the two letters involved the same basic violation – the promotion of a compound prior to approval – which on the whole has been one of the rarer violations cited by OPDP over the years (the leading being, of course, the lack or minimization of risk information). Does this thaw mean that OPDP is returning to enforcement activities or is it merely an anomaly. I think probably the latter, but time will tell. Note that one of the letters was issued in August, and one in September, but posting of the letters is not immediate.
  • FDA Blog Post About Access and Pricing – In the wake of the recent pricing action around Epi-Pen and the accompanying media and policy-maker attention to the issue of pricing as a result, FDA’s Dr. Janet Woodcock, head of CDER, authored a posting on the agency’s FDA Voice blog called “FDA and Access to Medications”. In it, she explains that while many people look to the agency around pricing matters, the agency does not have anything to do with pricing, but rather its role is confined to assessing the safety and efficacy of products. In response to some of the concerns raised about FDA’s pace at considering generics for approval, she stated that the agency stands ready to consider applications for generic products and puts the first of such applications in a category on a priority.
  • FDA AdComm Recos Removal of Boxed Warning – A joint meeting of the Drug Safety and Risk Management and the Psychopharmacologic Drugs Advisory Committees resulted in a majority vote recommending removal of a boxed warning that exists for smoking cessation product Chantix. The committee reviewed data from a study – Evaluating Adverse Events in a Global Smoking Cessation Study – EAGLES – that looked at safety issues associated with use of the product which had a boxed warning regarding neuropsychiatric events in patients, which the company says will be retained in the Warnings and Precautions section of the labeling. FDA may or may not follow the recommendation of its advisory committee

That’s all for this week. Have a good weekend everyone. Next week – a look at Breakthrough Therapy Designation.

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