Pilot Program to Improve Drug Safety

(FDA: Rockville, Maryland) -- In an effort to combat counterfeiting and contamination, the Food and Drug Administration (FDA) is launching a voluntary pilot program for drug makers to determine the practicality of developing a secure supply chain program.

The goal of the program is to allow 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.

Concern about imported drug ingredients grew last year after the deaths of patients given tainted supplies of the blood-thinner heparin made in China. “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,” says Michael Chappell, acting associate commissioner for regulatory affairs at FDA.

To qualify, applicants will need to meet the pilot’s criteria:

• Applicants must show that their drug products use a secure supply chain.
• 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.
• Foreign drug manufacturers and U.S. establishments receiving drugs must be FDA-registered and comply with good manufacturing practices.
• The active pharmaceutical ingredients imported must be used only to make FDA-approved drugs.

“We’re asking for a very robust and comprehensive description of the process by which the products come into the country,” commented Steve Silverman, assistant director in the compliance office of the FDA’s drugs center, in an interview with Reuters, the multimedia news agency..

For further information, visit www.fda.gov/bbs/topics/NEWS/2009/NEW01943.html.

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