FDA Launches Pilot Program To Improve the Safety of Drugs and Active Drug Ingredients Produced Outside the United States

The U.S. Food and Drug Administration today announced the launch of a voluntary pilot program 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 program. To qualify, applicants will 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 is to allow FDA to determine the practicality of developing a secure supply chain program. 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 program 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 U.S. Customs and Border Protection and other stakeholders. Information about the pilot appears in a Federal Register notice that went on display today.

"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 program. 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 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 two year pilot program must meet certain criteria, including:

* For finished drug products, the applicant must hold an FDA-approved drug application or must be the foreign manufacturer identified in an FDA-approved application;
* The active pharmaceutical ingredients imported must be used only to make FDA‑approved drugs;
* Foreign drug manufacturers and U.S. establishments receiving drugs must be FDA-registered and comply with Good Manufacturing Practices; and
* Applicants must show that their drug products use a secure supply chain.

The pilot program is planned to run for a period of two years.

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