The US Food and Drug Administration announced the launch of a voluntary pilot programme that would help promote the safety of drugs and active drug ingredients produced outside the United States.
The FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot programme. To qualify, applicants will need to meet the pilot programme's criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the country.
The goal of the pilot is to allow FDA to determine the practicality of developing a secure supply chain programme. Such a program would assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the programme and that may not be compliant. It will also expedite the entry of products meeting the pilot's criteria into the United States. The pilot was developed with input from US Customs and Border Protection and other stakeholders.
"This initiative creates incentives for drug makers to develop and maintain secure supply chains," said Deborah Autor, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research. "This is one of several agency initiatives to enhance drug product safety."
Each applicant may designate up to five drugs for selection in the pilot programme. To qualify, applicants will need to meet the pilot's criteria, including a requirement that they maintain control over the drugs from the time of manufacture through entry into the United States. A secure supply chain will help mitigate risks such as contamination and counterfeiting. Applications for participation in the pilot programme will be processed in the order received.
"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 US 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 programme."