WASHINGTON (Reuters) - U.S. regulators are asking drugmakers to submit more details about their supply chains under a pilot program announced on Wednesday to help protect patients from fake or tainted medicines from overseas.
Companies that voluntarily provide the information can get the products through U.S. border entry points more quickly, Food and Drug Administration officials said.
Concern about imported drug ingredients grew last year after the deaths of patients given tainted supplies of the blood-thinner heparin made in China. More than 80 percent of active drug ingredients are produced abroad.
The FDA is hoping to encourage companies to provide evidence they are tracking every step of manufacturing to ensure safety.
“We’re asking for a very robust and comprehensive description of the process by which the products come into the country,” Steve Silverman, assistant director in the compliance office of the FDA’s drugs center, said in an interview.
If companies submit their medicines to the test program, inspectors at the border can focus on other medicines that may be risky, the agency said.
The FDA said it would choose 100 applicants that can submit up to five drugs each under the pilot program, which would run for two years. Officials would then decide whether to expand it.
Reporting by Lisa Richwine; editing by Leslie Gevirtz