Two weeks before the year’s end – gifts are not yet bought much less wrapped. Cards not addressed because they likewise have not been purchased. Desperation and panic are tugging at my consciousness. And so let’s round up stuff from this week and hit the trail!
- CMS Finally Delivers on Sunshine Act Guidance – In late October, there was the Eye on FDA Let the Sunshine series on various aspects of the Sunshine Act and its provisions and how it might impact stakeholders, along with some observances of some of the emerging international efforts in transparency written in Part 1, Part 2 and Part 3, which included a podcast with a French colleague. Despite the fact that the Sunshine Act provisions were contained in the Patient Protection and Affordable Care Act directing CMS to deliver guidance on how medical product manufacturers will have to report financial relationships with physicians and teaching institutions by October 1, the agency let the deadline slide until this week when if finally released the guidance. What it lacked in timeliness it makes up for with bulk – the guidance is 121 pages. Happy reading.
- Online DTC Drug Promotion – And speaking of letting deadlines slide and late guidances, the FDA is publishing in the Federal Register a compilation of comments regarding online DTC drug promotion. It is not the overly tardy guidance that has flummoxed FDA for so long, but it does provide public commentary on the issue of fair balance in online ads with some insight into FDA thinking on the subject. Last Spring, the FDA published notice that it was going to be conducting some studies on the subject. This is a compilation of the comments received along with some responses about the conduct of those announced studies.
- FDA Issues Slew of Warning Letters on Lap-Band – In support of the postal service, FDA sent a bunch of warning letters that were posted recently respecting the promotion of the Lap-Band device for weight loss due to advertising that the FDA said failed to disclose risk properly.
- FDA Proposes Guideline on Women and Clinical Trials in Devices – And speaking of a bunch, the agency issued the latest in what has been a long string of policies and proposed policies around medical devices this year. Citing a rather old 2001 GAO report on the under-representation of women in clinical trials of devices when compared to drugs, today the agency announced the issuance of a proposed guideline that makes recommendations on how device manufacturers can improve upon the ratio of women to men in clinical trials. The comment period is open for 90 days.
Gotta go round up some gifts now. Have a good weekend everyone!