The Food and Drug Administration Launches Program to Improve Safety of Drugs and Active Drug Ingredients Produced Outside the United States

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The US Food and Drug Administration (FDA) on January 14, 2009, announced the launch of a voluntary pilot program that would help to 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 program. To qualify, applicants need to meet the pilot program'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 project is to allow the agency to determine the practicality of developing a secure supply chain program. Such a program would assist the agency in its efforts to prevent the import 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 program and that may not be compliant. It also expedites the entry of products meeting the pilot's criteria into the United States.

“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 5 drugs for selection in the pilot program. To qualify, applicants need to meet the pilot program'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 to mitigate risks such as contamination and counterfeiting. Applications for participation in the pilot program 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 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.”

Companies wishing to participate in the 2-year pilot program must meet certain criteria, including:

The pilot program is planned to run for 2 years. To view the application for the program, see: http://www.fda.gov/cder/fedreg/fda-3676.pdf.