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Bill calls for more inspections funded by pharma fees

By Nick Taylor, 04-Feb-2009

Related topics: Globalisation, Industry Drivers, QA/QC & validation

A bill has been introduced to the US House of Representatives that would require pharmaceutical manufacturers pay a fee and have their facilities inspected more frequently.

The bill has been introduced by Democrats in an attempt to beef up the US Food and Drug Administration’s inspections in response to the heparin contamination and other failures in supply chain security.

If passed into law the bill would require pharmaceutical manufacturers to pay an annual fee, which would be set not later than 60 days before the start of the fiscal year and be calculated based on whether the company operated foreign or domestic facilities.

In addition the bill would require facilities to be inspected every two years, or four years if the risks involved showed this to be sufficient. This would place significant strains on the FDA’s current capacity, hence the annual fees, but is deemed necessary by those who put forward the bill.

Representative John Dingell, who introduced the bill, said: “Americans shouldn’t have to worry about whether the medical products they use to improve their health might actually make them sick. I also look forward to continued discussions on additional improvements to the drug supply through pedigree systems.”

The bill would also require manufacturers to label the country of origin for each active pharmaceutical ingredient (API) used and the location where the finished dose was produced. However, the country of origin for excipients is not referred to in the bill.

The complete legislation can be found here .

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