Regulatory Developments in 2008

摘要

The divide between premarket and postmarket regulation of pharmaceuticals has officially been relegated to the archives. In 2008, much of regulators' activity focused on implementing this shift in approach, especially with respect to safety. In the US, for example, most of the US Food and Drug Administration's resources went towards the monumental task of meeting requirements and deadlines set out by the FDA Amendments Act of 2007 (FDAAA), which was enacted on 27 September 2007 and expanded the agency's authority, as well as reauthorising the prescription drug user fee programme, the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. An agency is only as effective as its resources, and much of the year was spent in crisis talks to get more funding for the FDA, which was repeatedly criticised for its inability to protect public health. Attempts were made in the US Congress to pass a regulatory pathway for follow-on biologies, but the funding issue and other more pressing eventsovershadowed lawmakers' efforts, leaving another year to go by without the passage of biosimilars legislation. In the European Union, the European Commission consulted on a plethora of issues, ranging from pharmacovigilance to patient information, culminating in the publication on 10 December of a massive "pharma package" of legal proposals. The world's top courts also heard various cases that may change the way the pharma industry does business in future (see Table 1).