16 ' REGULATORY & HEALTHCARE NEWS

Comparing US FDA and industry pharmacoeconomic guidelines

The phatmacoeconomic guidelines of the Phann.aceuticaJ Research & Manufacblr'erS' of America (PhRMA) do not incorporate standards on pharmaco­economic data in drug companies promotiona1 matrriaI.,. reported Dr Lou Morris. FDA Marketing Practices and Communication Braoch Chief, at the 31 st Anoua] Drug Information Associ~meeting in Orlando, US. In oontras~ the US FDA's dnilI-')u;delines OIl phannaco­ecooomjc studies 'an clearly focused ' on ..P'I'omotionai information. he says.··

'Globaldqr~' The aim of the PhRMA's pharmacoeconomic

guidelines is to support clinica1 decision-making, while the fDA's guidelines aim to support company marketing claims of cost effectiveness. Dr Morris pointed out Thus, the FDA believes that regulation of phannaco­economic evaJuations should focus on the end result of studies, whereas the PhRMA believes that the methodologies of pharmaooeconomic analyses need

to be regulated. 'The PhRMA require the best available data as input into pharmacoec:onomic studies and the FDA requires that such data are accurate and well­controlled.

The intention of the PhRMA guidelines is to increase public understanding of pharmacoeconomic analyses by minimising study bias and improving methodological transparency. said Dr Morris. The FDA draft report. on the other hand. is to educate people about FDA standards for eva1uating phannacoeconomic claims and promotiona1 materia1. Principles on the disclosure of study conduct and disaggregation of data are the on1y 'common ground' between the 2 sets of guidelines. he noted.

• The PhRMA guidelines, which a~ entitled 'Methodo­logical and Conduct Principles for PlwrmacoecOtlomic Research ', we~ released in December /994. •• 1M FDA draft guiikliMS, entitled 'Principles for the Review of Pha~ Promotioft', welt! It!leased in March this year.

FDAOD PbRMA pbImw '0 , •• Ria: II&flICY ~elaims. iDdIuUy (ocvxs 011 ~b; dUclollft, dig ~ptioa .n= common &f'OIIIId -COER', MOI'ril. F'DC R~_ Pink Sbtd : 17,l.lu.1199$ __

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