FDA: Congressional Report Faults Review Of Foreign Drugs
A General Accounting Office report has found "significant problems" with the Food and Drug Administration's efforts to protect American "consumers from low-quality drugs from foreign countries." The report, "originally published in March, was not publicly released by Congress, but a copy was obtained by the Washington Post." While the report "praised the agency for streamlining operations and making progress in speeding up turnaround time on inspection reports," the GAO found that "almost 60% of reports were submitted later than the agency standards called for." In addition, the GAO "cited several problems with the FDA's systems for ensuring that imported drugs are manufactured to the same standards as those produced" domestically. In one instance, the report found that FDA officials accepted a foreign manufacturer's "written promise" to "upgrade its testing procedures," instead of going through with a "reinspection."
No Cause For Alarm
Rep. Thomas Bliley Jr. (R-VA), the chair of the House Commerce Committee, said: "This report should help the FDA defuse what has properly been called 'a ticking time bomb.' We don't want to scare people but we sure want this problem to be fixed immediately." Rep. Joe Barton (R-TX), who commissioned the GAO report in his capacity as chair of the Commerce subcommittee on oversight and investigation, said the findings highlight the need for "significant improvements to ensure that the quality of the drug is the same, regardless of whether the drug is from the United States or from overseas." Barton said his subcommittee will hold hearings on the issue "this summer." An FDA spokesperson said, "With the volume of imports having increased dramatically over the past five years, the FDA is already developing a more scientific, risk-based strategy enabling us to use our resources in the most effective manner possible" (Schwartz, 5/1).