The quantity of prescription drugs imported into the USA has more than tripled in the past few years, yet the number of Food and Drug Administration officials responsible for inspecting medicines manufactured abroad and imported into the USA has risen by just 10% over the same period, according to an investigation conducted by the journal CongressDaily and reported by www.kaisernetwork.org.
Inadequate funding and staffing levels at the agency mean that the breadth and frequency of inspections carried out by FDA drug inspectors and biologists cover only a fraction of the numbers necessary to ensure the safety and purity of imported medicines, according to the study. Nor is the system able to ensure that overseas producers are compliant with drug manufacturing standards, says the journal, while the monitoring of overseas manufacturers which have previously been placed on US watch lists for “questionable practices or lapses” is also put at risk by the agency’s inadequate staffing and funding levels, it adds.
The report points out that critics believe the agency’s policy of targeting the “riskiest” producers, both domestic and overseas, for its investigations could prove inadequate as the volume of prescription drug imports rises, but it also quotes a response from the agency stating that “intelligent, risk-based inspections are more important than absolute numbers of inspections.”
Moreover, CongressDaily also says its investigation found that the agency staff who are charged with conducting inspections are equal to the levels of competence and expertise required for the job. By Lynne Taylor