Regulatory Writing

Gregory Morley; Stephen Gilliver; Diarmuid De Faoite; Elise Langdon-Neuner

Volume 21, Issue 2 - Medical Writing in Paediatrics

Regulatory Writing

Authors: Gregory Morley, Stephen Gilliver, Diarmuid De Faoite, Elise Langdon-Neuner

Abstract

The Physicians Payment Sunshine Act – casting a shadow over clinical research?

In October 2010, the American congress passed the Physicians Payment Sunshine Act, which will force drug and medical device manufacturers to disclose their payments to healthcare professionals (HCPs). Starting this year, drug makers are required to track all payments to HCPs and from September 2013 onwards, details of these payments will be made freely available on the Internet for all and sundry to analyse. In other countries too, for example the UK with the new Association of the British Pharmaceutical Industry (ABPI) code of practice update, drug companies will be forced into disclosure, though the requirements are usually somewhat less stringent. In response, pharmaceutical companies have been scrambling to become compliant. This is no mean feat, given the complexity and extent of the relationship between drug companies and HCPs. In particular, large drug companies operate in many different countries with many different business cultures and attitudes, and under many different legislative frameworks.

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Volume 21, Issue 2 - Medical Writing in Paediatrics

Regulatory Writing

Authors: Gregory Morley, Stephen Gilliver, Diarmuid De Faoite, Elise Langdon-Neuner

Abstract

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