Experts say the current U.S. flu vaccine shortage “highlights the weaknesses in the international system for regulating medicines,” particularly as more multinational drug companies are producing their medications overseas, the Wall Street Journal reports. According to the FDA, the “rising number of factories to police all over the globe” make it much harder for the agency to inspect all of the manufacturing sites regularly; in 2000, nearly 80% of the ingredients found in U.S. medications were produced abroad. Although the agency has significantly ramped up its inspections, the FDA in 2000 reported that it was “falling considerably short” of its required biennial inspections of domestic and international production facilities outside of vaccine manufacturers. And while drug makers are required to inform the FDA when manufacturing problems arise, critics say that the FDA relies too heavily on information from drug makers rather than actual plant inspections. However, the Journal notes that the FDA has been making strides to “improve its international oversight” by establishing greater “cooperation with foreign counterparts.” For instance, the agency last year reached an agreement with the European Medicines Agency, the EU’s drug-regulation agency, to share information about manufacturing sites and drug applications; however, because individual European countries handle the “bulk of inspections,” the FDA needs an agreement with each EU nation to “have a complete picture” (Whalen/Tam/Lueck, 11/5).
