BayBio Lunch & Learn: Preparing for the Sunshine Act: Don’t be Left in the Dark
A Final Rule to implement The Sunshine Act, intended to enhance transparency of financial arrangements between industry and healthcare providers, was issued February 1, 2013.
In this Lunch and Learn session, we will address The Act’s requirement of “applicable manufacturers” of drugs, devices, biologicals and medical supplies to report to HHS certain payments or transfers of value to physicians and teaching hospitals, as well as information about ownership or investment interests held by physicians in such manufacturers, and posting of submitted payment and ownership information on a public website.
This session will also address issues that those involved in clinical research should consider, including:
- Will payments to physician researchers for early-stage development work be reportable?
- How will appropriate contextual information about research payments be included on the website?
- How will the Act impact early co-development work involving start-ups and established “applicable manufacturers”?
- How will provisions in contracts between industry research sponsors and contract research organizations, and between contract research organizations and research sites change?
- How will disputes about reported payments between industry research sponsors and teaching hospitals and physicians be resolved?
- How will Sunshine reports be reconciled with other requirements governing the collection and reporting of similar information(e.g., the NIH Final Rule on conflicts of interest, and state reporting laws)?
- Will the payment reports achieve the Act’s goal of reducing risks of inappropriate financial incentives interfering with medical judgment and patient care?
Partner, Drinker Biddle
BayBio Lunch & Learn:
April 18, 2013
HCP/BayBio Event Center
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