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Pharma Research Under the Microscope
The Council of American Survey Organisations (CASRO) has announced that its GPA and Legal Team is looking into increasing government scrutiny of pharmaceutical research in the US, and problems with differing US and EU industry guidelines for research in the sector.
In its latest legal update, Research & Regulation Bulletin, the association details a recent Dept of Health and Human Services (HHS) Advisory Opinion on whether physician incentives for pharma research violate a federal 'antikickback' law. In the June 1, 2004 advisory the HHS declined to take action against a pharma research agency for payments made to doctors, but warned that 'anything more than purely nominal payments to physicians could result in action against the payor'.
A separate issue has arisen over differences in US and EU guidelines for pharma MR. CASRO GPA has received several enquiries from members who have been asked to comply with EphMRA (European Pharmaceutical Marketing Research Association) guidelines, which focus more on clinical pharmaceutical research than US versions, and require researchers to follow the FDA's guidelines for 'good clinical practice'. The latter require clinical researchers to report any 'adverse effects' that respondents may reveal or discuss in a survey and CASRO considers them impractical for most US pharma research interviewers, who 'do not qualify as 'clinicians'' and are therefore unable to recognize and report 'adverse effects'.
CASRO's web site is at www.casro.org
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