FDA moves to make imports safer
pharmafile | January 16, 2009 | News story | Manufacturing and Production |Â Â FDA, supply chainÂ
The Food and Drug Administration is stepping up efforts to prevent counterfeit and contaminated medicines entering the US, and is encouraging drugmakers to keep closer tabs on their supply chains.
The agency is setting up a voluntary pilot programme called Secure Supply Chain to explore the practicalities of developing a system for maintaining integrity of supply.
The scheme will enrol 100 participants who must be able to show they can maintain control of ingredients and finished drug products from the time of manufacture up to entry into the US. Criteria include FDA approval for all imported pharmaceutical ingredients, while foreign manufacturers and US receiving companies must be FDA-registered and comply with Good Manufacturing Practices.
Participants in the programme can include up to five products in the pilot, which will run for two years. In return, companies in the programme may qualify for fast-track entry of their products into the country, said the FDA.
"With the increase of drug products produced outside the USA, 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 US laws," said Michael Chappell, acting Associate Commissioner for Regulatory Affairs at the FDA.
Criticism of the FDA's safety record reached a peak last year when contaminated heparin sourced from China by Baxter entered the US supply chain. The FDA has responded by introducing a number of new initiatives to shore up the US medicines supply chain.
In addition to the latest pilot programme, the agency has been setting up overseas offices to help it collaborate with other regulatory authorities, particularly on areas such as enforcement and product quality issues. To date it has opened three offices in China and one in Costa Rica.
In addition, the FDA released a guidance on Good Import Practices for comment on 12 January, which aims to "prevent or detect potential problems at critical points along the products life cycle to avoid placing the US consumer at risk" It is available on the agency's website here.
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