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USP, FDA must be proactive in updating monographs

By Nick Taylor , 27-Apr-2010

The USP and FDA must work to identify counterfeited or intentionally adulterated products before they enter the healthcare system by collaborating on the modification of monographs, according to Margaret Hamburg.

Heparin contamination highlighted the need to remain vigilant against the threat of counterfeit or adulterated products and prompted the organisations to collaborate to add new tests to its monograph.

Speaking at the United States Pharmacopeial (USP) convention Margaret Hamburg, commissioner of the US Food and Drug Administration (FDA), detailed why collaboration on monographs needs to be an ongoing process.

Hamburg explained that collaboration between the FDA and USP is essential and must occur proactively to protect the public from potentially dangerous products.

The organisations “must jointly identify drug ingredients and products that would benefit from an up-to-date monograph, starting with those that have the greatest impact on public health”, added the commissioner.

Hamburg is aiming to ensure the FDA can prevent public health crises from occurring, instead of just responding to them when they arise, and this will require continuous vigilance, especially in the changing pharma environment.

We cannot afford to rely on 20th century approaches to review 21st century products”, explained Hamburg, adding that “the growing demands of globalisation” necessitate new approaches.

These include working closely with other national regulatory authorities, international and national organisations and industry, because the “FDA simply does not have – and will never have – the resources to inspect every foreign manufacturer, or every shipment of products from overseas”.

Global expansion by the USP, which has established a presence in Switzerland, India, China and Brazil in the past five years, puts it in a good position to work with the FDA on ensuring quality around the world.

Below is a visualisation, created using Wordle , showing the most frequently used words in Hamburg’s speech.

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