FDA Program Aimed at Improving Foreign Drug Safety

The number of foreign-produced drug products imported into the United States rises each year. Currently, more than 80 percent of active drug ingredients are manufactured abroad. All imported drug products are required to meet the same standards as domestic goods, meaning they must be safe, effective, and unadulterated and must contain informative and truthful labeling in English.

Drugs and ingredients being imported or offered for import into the U.S. are subject to inspection by the Food and Drug Administration (FDA), as well as the international facilities where the drugs are manufactured. From fiscal year 2002 through fiscal year 2007, the FDA conducted an average of 241 foreign establishment inspections per year, according to a report by the Government Accountability Office (GAO). Comparing this average number of inspections with FDA’s list of 3,249 foreign establishments it used to prioritize its 2007 GMP surveillance inspections, which are used to monitor the quality of marketed drugs, suggests that the agency inspects only about 7 percent of foreign establishments in a given year. At this rate it would take the FDA more than 13 years to inspect this group of establishments once, assuming that no additional establishments are subject to inspection.

Hopefully, a newly-launched pilot program developed with input from U.S. Customs and Border Protection will help to address these inspection concerns and mitigate risks such as contamination and counterfeiting. The FDA plans to select 100 applicants to participate in the two-year Secure Supply Chain program. To qualify, participants will have to meet the program’s criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the United States. Each applicant may designate up to five drugs for selection in the pilot program.

The pilot program’s goal will be to determine the practicality of developing a secure supply chain program. Theoretically, such a program would allow the agency to focus its efforts on investigating foreign manufacturers that fall outside the program and may not be compliant. It would also speed the importation for medications that meet program criteria. “With the increase of drug products produced outside the United States, it is critical that the FDA concentrate its resources on companies that pose the highest risk of importing products that don’t meet the FDA’s standards and violate U.S. laws,” said Michael Chappell, acting Associate Commissioner for Regulatory Affairs at FDA. “Consumers should know that only companies that maintain control over their products will be selected into this pilot program.”

Last year, the FDA came under widespread criticism for failing to inspect the Scientific Protein plant in China. Had they completed their scheduled inspection, they may have been able to keep contaminated heparin from reaching the U.S. market. The heparin was found to have been adulterated with oversulfated chondroitin sulfate, apparently added deliberately in China at some stage in the production process in order to increase profits. The contamination necessitated a number of product recalls and resulted in more than 150 adverse reactions and more than 80 deaths.