21st Century Cures changes would loosen Sunshine Act's CME disclosure rules
- The 21st Century Cures initiative is a bipartisan FDA reform bill, which if passed, would make the most sweeping changes to the FDA, NIH, and American healthcare since the advent of the Affordable Care Act (you can read BioPharma Dive's coverage of the original draft bill, as well as change in a newly-released and updated discussion draft, here and here).
- The bill was initially publicized in January and recently modified and simplified to a certain extent. But as Ed Silverman points out, one of the changes that we didn't cover in our feature is to provisions of the Sunshine Act requirements for disclosing payments from pharma companies to doctors for continuing medical education (CME) and speaking fees.
- The issue of CME reporting in the federal government's Open Payments database has been controversial.
The gist of advocating for rolling back mandatory CME reporting is that it could hamper CME, which "is how doctors get the latest information about drugs," according to John Kamp, head of the Coalition for Healthcare Communications. On the other side, however, some experts contend that CME is a key route to marketing drugs, and that if CME reporting is rolled back, it could also lead to rolling back other reporting requirements.
While it's not clear how the 21st Initiatives Cure will be finalized, this bill has gained considerable momentum in the last two months and will most likely lead to some level of noteworthy reform.