On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
Sunshine Regulations to Unmask PODs' Financial Relationships
In general, the regulation tracks the statute in requiring AMs and AGPOs to annually report direct or indirect ownership and investment interests held by physicians and their immediate family members. These reports are in addition to those for payments and other transfers of value made to physicians under § 403.904 of the regulations.
The regulatory preamble specifically notes on several occasions that distributors (including PODs) are AMs if they take title (buy-and-resell or “stocking distributor” PODs). All other POD models are AGPOs under the new law, whether they purchase product or negotiate prices/arrange for purchase in exchange for commissions or administrative fees. The preamble goes on to state that CMS “intend[s] for [the definition of AGPO] to capture as many PODs as possible, while still aligning with the statutory language.” Accordingly, when the obligation to collect data on payments and ownership interests takes effect (August 1, 2013), all PODs will be obliged to collect this information and report annually on the full extent of their financial relationships with owner physicians, and PODs that are AMs will be obligated to report not only financial relationships with owner physicians, but also payments or transfers of value to all physicians, whether or not the physicians have ownership interests. See our Health Alert, Key issues concerning PODs under the federal Sunshine Law, for more information.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017