FDA NEWS: Pilot Program to Improve the Safety of Drugs produced outside the US

By: Judy Fox, CIS Senior Compliance Consultant
judyfox@cis-partners.com

On January 14, 2009, the FDA announced the launch of the Secure Supply Chain pilot program. The FDA believes the new voluntary, two-year pilot program will help promote the safety of drugs and active drug ingredients produced outside the United States, and brought into this country for sale and for use in drug manufacturing. The goal of the pilot program is to determine the feasibility of developing a permanent Secure Supply Chain into the United States.

If the pilot program is successful and indicates that a permanent program is feasible, the Secure Supply Chain would assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements.
A successful program would allow the FDA to accomplish the following:

• Aid in preventing the importation of drugs and drug products that do not meet the current FDA requirements ;
• Allow the agency to focus its resources on foreign-produced drugs that fall outside the program and may not be compliant;
• Expedite the importation of drug products that meet pilot program criteria;
• Aid in mitigating the risk of contaminated or counterfeit drugs entering the US supply chain.

Initially, the FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program. To qualify, companies must meet certain criteria, including the requirement that manufacturers have control over their drug products, from manufacture through their entry into the United States. Each applicant may designate up to five (5) drugs for selection into the pilot program, provided:

• The applicant holds an FDA-approved drug application, or is the foreign manufacturer in an FDA-approved application;
• The active pharmaceutical ingredients imported are used only to make FDA-approved drugs;
• Foreign drug manufacturers and U.S. establishments receiving drugs are FDA-registered, and compliant with Good Manufacturing Practices;
• Applicants show that their drug products use a secure supply chain.

Deborah Autor, Director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research (CDER) was quoted as saying, “This initiative creates incentives for drug makers to develop and maintain secure supply chains. This is one of several agency initiatives to enhance drug product safety.”

Michael Chappell, acting Associate Commissioner for Regulatory Affairs at the FDA, was also quoted in the press release as saying, “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. Consumers should know that only companies that maintain control over the products will be selected into the pilot programs.”

Companies that would like to participate will be processed in a first come, first served basis. There was no mention of whether the participants and products for the pilot program will be made public.

The application for the program can be found at: http://www.fda.gov/cder/fedreg/fda-3676.pdf
The federal register notice can be found at: http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-N-0656-N.pdf

Source: FDA News Releases