FDA pilot program seeks to prevent importation of dangerous drugs

The U.S. Food and Drug Administration recently announced a voluntary pilot program to ensure the safety of drugs and active drug ingredients produced outside the United States. The FDA said it will select 100 applicants to be part of a new Secure Supply Chain pilot program.

To qualify, applicants must meet the pilot program’s criteria, including maintaining control over drugs from the time of manufacture through entry into the country. With the pilot program, FDA plans to determine how easy it will be to develop a supply-chain program that would help the agency to prevent importation of drugs that do not comply with FDA requirements.

A secure supply-chain program would help the agency prevent importation of drugs that do not meet FDA standards by focusing its resources on drugs produced outside the United States that fall outside the program and may not be compliant. It will also expedite the entry into the United States of products meeting program criteria.

The pilot was developed with input from U.S. Customs and Border Protection. Information about the pilot appears in a Federal Register notice that went on display in early January. “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.”

A secure supply chain will help reduce risks such as contamination and counterfeiting.

“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.