BEIJING - One year after adulterated heparin sourced from China began triggering scores of adverse reactions and deaths in U.S. patients, U.S. FDA is preparing to launch a voluntary pilot program aimed at helping prevent contaminated drugs from entering the country.

The program's ultimate goal is to foster and monitor secure supply chains worldwide as the production of drugs and active pharmaceutical ingredients for the American market spreads out across the globe at an ever-quickening pace.

"The goal is to allow the FDA to determine the practicality of developing a Secure Supply Chain program for finished products and APIs intended for human use," said Gabriela Carias-Green, an associate at the Washington, D.C. office of the law firm Hogan & Hartson. "Participating in the pilot could provide two key benefits for importers: faster importation during the pilot program and the opportunity to shape a potentially important federal program," added Carias-Green, who specializes in U.S. Customs and world trade regulations.

The FDA worked with U.S. Customs and Border Protection to design the new pilot, and the two governmental organizations will collaborate in implementing the supply chain scheme. The drug regulator is now publicizing plans for the program and asking for feedback. Before its launch, companies providing comments and suggestions could actually help shape the final contours of the initiative.

Efforts to design and guarantee secure supply chains stretching out from drug and API manufacturing sites across the world and leading to U.S. border entry points "would assist the FDA in preventing the importation of adulterated, misbranded or unapproved drugs," Carias-Green told PharmAsia News.

The new pilot was on the drawing boards before Chinese heparin contaminated with a look-alike drug started causing a spike in extreme adverse reactions a year ago, said Linda Horton, a partner at Hogan & Hartson in Washington who focuses on life sciences-related issues and legislation. "But I'm sure the heparin incident accelerated this project," she added (Also see "U.S. FDA Set To Strengthen Inspections Of Chinese Drugmakers, Search For Adulterants In Aftermath Of Heparin Deaths – CDER Official" - Scrip, 28 October, 2008.).

"This program is part of the response to fast-paced globalization of the drug industry," Horton told PharmAsia News. "The FDA is trying to cope with the rapidly growing number of facilities abroad, including in China."

Horton, a former FDA Director of International Policy, said that drug safety problems stemming from small-scale Chinese producers of raw components that failed to meet U.S. GMP standards stretch back more than a decade.

The pilot project, Horton explained, is just one part of the FDA drive to ensure the safety and quality of imported pharmaceuticals, and is linked to its Beyond Our Borders program.

Last year, the FDA set up its first offices in the Chinese cities of Beijing, Shanghai and Guangzhou (Also see "U.S. FDA Launches First Overseas Office in Beijing" - Scrip, 20 November, 2008.).

During the first phase of the Secure Supply Chain project, the FDA will select 100 of the companies applying to join, and each company can designate up to five drugs for inclusion in the program.

"Applicants will be expected to maintain records that document the drugs' movement through the secure supply chain from the point of manufacture to the point of receipt by the ultimate consignee and make these records available to the FDA if requested," said Carias-Green.

U.S. importers or foreign makers of drugs or APIs applying to take part in the pilot project must be able to "show that their drug products use a secure supply chain," she said. "The applicant must have a plan in place for promptly correcting any concerns the FDA identifies regarding its secure supply chain or specific importations."

U.S. pharmaceutical companies sourcing drug components abroad "need to take measures to ensure APIs from foreign manufacturers are made in line with GMP standards," explained Horton.

The FDA could use the program to create a fast-track import and approval process for companies that emerge as leaders in guaranteeing the safety of their products and supply chains, both lawyers said.

Taking part in the pilot "is almost like a certificate that you can hang on the wall," explained Horton. "Probably we will see the big pharmas participating," she predicted.

The pilot project is tentatively slated to run for two years, during which FDA will monitor its impact and potential for expansion.

- Kevin Holden (pharmasia@elsevier.com)

In Wake Of Heparin Deaths, FDA Set To Launch Pilot Project Aimed At Preventing Imports Of Adulterated Drugs

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