A recent insight enabled by witnesses to the congressional subcommittee has put the FDA in a bad light.
According to the report, the procedure adopted by the Food and Drug Administration to ensure the safety of drug ingredients from foreign companies is not fool proof. Therefore the agency is unable to guarantee complete safety of drugs. Further, there was a huge gap in the way FDA scrutinized domestic drug companies vis a vis foreign drug suppliers.Nearly 80% of the ingredients of drugs manufactured by American companies are sourced from abroad. Yet, FDA was found to be deficient in record keeping, as the exact data about drugs inspected was not clear.
Explaining the facts to the committee, Marcia Crosse, director of health care for the Government Accountability Office said, “More than nine years after we issued our last report on this topic, F.D.A.’s effectiveness in managing the foreign drug inspection program continues to be hindered by weaknesses in its data systems.”
The fear regarding the safety of drugs has increased following the recent report about the poor quality of drug ingredients from China. Apparently, china’s drug regulators were not up to the mark in regulating their drug suppliers.
The investigation revealed that FDA inspects domestic drug makers once in two years but there is no such inspection schedule for foreign suppliers. Moreover, drug agencies depended on volunteers to conduct the inspections abroad, which were dictated by travel schedules rather than necessity. Further, in place of surprise inspections which are the norm in domestic drug companies, the foreign companies were given sufficient notice.
The checks conducted in this manner may not be absolute, it was feared.
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