Fast tracking drugs to patients

Regulatory approval of drugs can be an obstacle course and is a process that frequently comes under fire for being too rapid or too lax. Critics often complain that pharmaceuticals are approved too slowly by a process that is too costly and byzantine, which has fatal effects for patients when life‐saving anti‐cancer and anti‐HIV drugs are involved. The US Food and Drug Administration (FDA), the agency responsible for approving new drugs, has reacted to long standing criticism by streamlining some of its guidelines and procedures, but the bioterrorism crisis in the USA has prompted further scrutiny of the whole drug approval system. The FDA's European counterpart, however, the European Agency for the Evaluation of Medicinal Products (EMEA) in London, so far has largely resisted expediting its approval process. But it is unclear whether a faster and slimmed‐down approval process is indeed better for public health. Critics of more rapid approval point to 12 drugs in the past 4 years that were withdrawn from the US market due to serious side‐effects and that were, they believe, approved too hastily.The recent bioterrorism attacks with anthrax spores have again pushed this topic onto the front pages. With frightened Americans hoarding Cipro, the only antibiotic approved by the FDA to treat pulmonary anthrax, and Bayer, its German manufacturer, struggling to meet the increasing demand, many started calling on the FDA to quickly approve other antibiotics to treat anthrax. Similarly, pharmaceutical and biotechnology companies, as well as the average citizen, are wondering whether the industry will be able to manufacture, and the FDA approve, enough smallpox vaccine for the entire country. An editorial in The Wall Street Journal (November 15, 2001), entitled ‘A Wartime FDA’, emphasised that the current exigencies of conducting a war on terrorism require the FDA to streamline the regulatory maze …