FDA: Agency Cautious About Drug Import Bill
While the House and Senate work to prevent the FDA from taking action against individuals who import medicines from other countries, the FDA maintains that "relaxing current restrictions would weaken FDA's ability to act on public health and safety," CongressDaily/A.M. reports. In addition, the agency "is working behind the scenes to detail the potential safety issues and enforcement costs a new law could impose" (Fulton, 7/28). U.S. citizens now are prohibited from importing drugs from foreign countries, even if those medicines are sold at lower costs. Pharmaceutical companies have argued that if the law is changed, it "will pose a threat to consumers, possibly exposing them to counterfeit or substandard medicines." Both the House and Senate have approved amendments to restrict the FDA from enforcing laws on prescription drug importation and are working to retain the amendments in the FY 2001 Agriculture appropriations bill. A conference committee is working out the differences between the House and Senate versions (American Health Line, 7/21). In a letter to House Commerce Committee ranking member John Dingell (D-Mich.), the FDA said that because of the "significant impact these amendments will have on FDA's ability to protect the public health, they are not the appropriate solution to the drug pricing problem." The letter continues: "These amendments will likely encourage the very sources of adulterated, misbranded and unapproved drugs that were cut off [by current law] to begin shipping again. FDA, with its limited resources, would be extremely hard-pressed to do the investigative work necessary to discover and stop these new sources of potentially harmful products." According to FDA sources, the agency would not be able to enforce safety standards should the amendments be approved without $90 million in new funding. CongressDaily/A.M. reports that the FDA is in the process of drafting a plan to enforce the law, but "appears reluctant to come out strongly on any of the measures."
At the same time, some lawmakers said that the safety arguments "are overblown." Rep. Jack Kingston (R-Ga.) said, "It's not about drug safety. It's about profit safety." Sen. Paul Wellstone's (D-Minn.) spokesperson added that "other countries have been able to control imports without major safety problems." Conference committee members have "vowed to reach a compromise that would enact the provisions ... but preserve the safety of the drug supply." Rep. Bernie Sanders (I-Vt.) said, "We will work to make sure the legislation has passed 100% of FDA's safety tests" (Fulton, 7/28).