The Senate Health, Education, Labor and Pensions (HELP) Committee is examining the globalization of the pharmaceutical drug market and supply chain. According to a new report by the Government Accountability Office (GAO) released today, up to 80% of the chemicals and ingredients of prescription drugs are made outside the United States.
The GAO report said the FDA inspected only 8% of foreign drug manufacturers in 2007, and it highlighted several shortcomings of the Food and Drug Administration (FDA), which include the lack of access to inspect foreign drug makers' facilities and the FDA's lack of correct information about these foreign companies.
The United States must enter into agreements with other countries for the FDA to inspect international drug manufacturing plants. For instance, in China, U.S. inspectors must receive a letter of invitation from the foreign drug maker before an inspector can enter the country. Deborah Autor, a regulator at the FDA said "the playing field is not level" between domestic and foreign drug manufacturers.
Senator Tom Harkin (D-IA), Chair of the HELP Committee, is considering pushing for additional safeguards of the drug supply chain, including cooperation with other countries. Many Republicans are cautious about regulations, which they say are hurting drug makers, pharmacists and others in the drug industry. "My concern is that the FDA is over regulating, not under regulating," Ranking Member Mike Enzi (R-WY) said.
The GAO does not recommend that the FDA conduct more inspections, but that the agency implement training programs for foreign drug makers, increase oversight at U.S. border entrances and move to a risk-based inspection process instead of inspecting domestic drug makers every two years.
Representatives from pharmaceutical lobbying organization, PhRMA, and the public interest Pew Health Center also testified.