Drug Safety in Europe: A Model for the United States?

Two of the leading players in the global pharmaceutical market are the United States, where the Food and Drug Administration (FDA) regulates drug safety, and the European Union (EU), where a network of regulators in the 27 EU member states oversee drug safety - both directly and through EU-level approaches coordinated by the European Commission and the European Medicines Agency (EMEA).

In the United States, an intense debate about the adequacy of FDA authority and programs to ensure drug safety has erupted. Among those involved are the agency itself, a broad array of stakeholders, prestigious bodies like the Institute of Medicine, and above all, the US Congress.

The core question is whether the FDA drug safety program is in need of legislative repair. The jury is still out on the question but, with the shift in Congressional control from Republicans to Democrats, enactment of legislation to tighten drug safety control (whether needed or not) seems more likely.

Quite naturally, policymakers will be looking across the Atlantic to see whether EU regulators have arrived at any better approaches. Hogan & Hartson's chapter in a recent book published by Ernst & Young provides EU perspectives to contribute to the debate about regulatory mechanisms to enhance safety of marketed pharmaceuticals.

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