Chapter

The Regulatory Science and Politics of Risk Management: Who Is Being Protected?

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Abstract

The practice and implementation of post-market risk management strategies for new drugs, especially innovative pharmaceuticals was introduced in the neo-liberal period and may be regarded as part of the neo-liberal reform agenda, especially when it emerged in the US in the mid-to late 1990s (FDA 1999a). As we explained in Chapter 2, risk management policy developed at the FDA in response to an increase in the number of drug product innovations having to be withdrawn from the market on safety grounds, which was, in turn, related to the reductions in new drug review times during the 1990s. The pharmaceutical industry and the FDA both wanted the number of drug safety withdrawals reduced. The industry because such withdrawals were against companies’ direct commercial interests while indirectly eroding public confidence in the industry and its products; the FDA because of pressure from industry, the Congress, and elements of the medical profession attached to prescribing a drug when withdrawn, combined with the fact that when a drug was withdrawn from the market it tended to undermine the agency’s reputation.

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