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Report Questions Safety of FDA's Standards for Imported Drugs

By John Schwartz
The Washington Post

The Food and Drug Administration has taken steps to ensure that imported medicines are safe, but significant problems remain with how the agency protects U.S. consumers from low-quality drugs from foreign countries, according to a new con- gressional report.

The report from the Government Accounting Office praised the agency for streamlining operations and making progress in speeding up turnaround time on inspection reports, which constitute the first line of defense against dangerous products entering the country. Still, almost 60 percent of reports were submitted later than the agency standards called for, the GAO said.

The FDA is responsible for the safety and effectiveness of drugs, medical devices and other products constituting nearly 25 cents of every consumer dollar spent.

Its vigilance over drug imports has been questioned for years. The new criticisms tracked those of two previous studies of the long-troubled program. The report, originally published in March, was not publicly released by Congress but a copy was obtained by The Washington Post.

The report cited several problems with the FDA's systems for ensuring that imported drugs are manufactured to the same standards as those produced in the United States.

After telling one foreign company that it had to upgrade its testing procedures, for example, the report states that FDA reviewers accepted a manufacturer's written promise to fix the problems and did not call for reinspection - "even though agency documents raised questions about the manufacturer's trustworthiness."

One drug manufacturer in India was allowed by the FDA to continue exporting antibacterial agents to the United States even though a 1994 inspection showed that the company could not even test the product or the plant's water supply for impurities. That inspector found problems with the plant that had not been fully corrected after having been cited in an inspection conducted nine years earlier. The inspector and district office recommended that the company's products not be allowed into the United States, but the FDA's drug division never sent the warning letter it had planned. The FDA said the plant was inspected again, however, and found to have complied with U.S. manufacturing standards.

Another inspection of a foreign manufacturer turned up serious safety program deficiencies and a possible coverup - and an incident in which the company shipped containers labeled as a bulk pharmaceutical chemical that actually contained a herbicide.

"This report should help the FDA defuse what has properly been called "a ticking time bomb,' " said Rep. Thomas Bliley (R-Va.) chairman of the House Commerce Committee, through a spokesman. "We don't want to scare people but we sure want this problem to be fixed immediately."

FDA spokeswoman Lorrie McHugh said that the agency recognizes that improvement is still an "ongoing challenge."