Accepted Paper:

"The most generous statement justifiable": Analytic capabilities and investigative norms in the regulation of the anti-influenza drug Relenza   

Author:

Shai Mulinari (Lund University)

Paper short abstract:

Relenza was launched in the late 90’s. This paper investigates why FDA and European regulators came to divergent interpretations regarding Relenza efficacy, and why the FDA approved the drug despite an overwhelmingly negative opinion in its Antiviral Drug Products Advisory Committee.

Paper long abstract:

Glaxo Wellcome launched the anti-influenza drug Relenza in the late 90's. Although heralded as breakthrough treatments, the efficacy of Relenza and its sister drug Tamiflu has been the subject of much debate, especially after many countries decided to stockpile the drugs to safeguard public health in event of a major influenza outbreak. In the midst of controversies, which are still unfolding, medical researchers have been puzzled by the fact that the FDA approved much more cautious efficacy statements than European regulators. This paper investigates (1) why FDA and European regulators came to divergent interpretations regarding Relenza efficacy, and (2) why the FDA approved the drug despite an overwhelmingly negative opinion in its Antiviral Drug Products Advisory Committee. It is argued that European regulators displayed considerably weaker analytic capabilities and investigative norms, which may be linked to the relatively weaker potency of European regulatory authorities. Consequently, European regulators were not in position to thoroughly scrutinize the manufacturer's analyses and knowledge-claims, which is reflected in assertions more favorable to the drug in European labels. It also argued that the FDA, to neutralize the Advisory Committee's negative advice, used the agency's analytic capabilities to help construct an argument for approval. This involved finding "the most generous statement justifiable" regarding efficacy; still, FDA's efficacy assertions were more moderate than European regulators' assertions. It is suggested that FDA's collaborative and "constructivist" approach was motivated, at least in part, by an institutional culture ushered by the FDA Modernization Act of 1997 that incentivized cooperation with industry.

Panel T017
STS for pharmaceuticals and public health policy