Bill Would Regulate Overseas Drug Studies
American pharmaceutical companies planning clinical trials in developing counties would be prohibited from shipping experimental treatments to those countries without first providing "details" of the proposed studies to U.S. regulators under legislation approved by a House committee last week, the Washington Post reports. The requirements, added as an amendment to the Export Administration Act, which passed the House International Relations Committee on Wednesday, would require drug companies to "secure an export license" for untested treatments. To obtain a license, drug companies would need to verify that an ethics panel had approved the study. The legislation also would require the president to file an annual report with Congress that would allow the public to "track" the countries and treatments involved in the "potentially hazardous drug experiments." Rep. Tom Lantos (D-Calif.), the bill's co-sponsor and ranking member of the committee, said the bill would "stop a very disturbing practice." He added, "More often than not, human participants in clinical trials overseas are poor, illiterate and uninformed. Poverty in these countries provides an opportunity for unethical researchers to disregard the protection of the rights and welfare of poor individuals, to hurry their tests and rush drugs to market. ... These tests must be conducted under standards no less rigorous than if these tests were conducted in the U.S." Lantos said that the bill was "sparked" by a Post series in December called "The Body Hunters," which chronicled experiments by American companies in foreign countries, including a Pfizer study on children with meningitis in Nigeria in which 11 children died. The Post series also prompted HHS to establish an office to monitor research conducted overseas. In addition, a presidential panel recently pushed for more "safeguards" to prevent U.S. researchers from "unethically testing medicines" in developing countries (Stephens/Flaherty, Washington Post, 8/4).