Consumer and Drug Industry Representatives Back New Fees to Cover Inspections

WASHINGTON – Allan Coukell, director of the Medical Safety Division of the Pew Health Group, issued the following statement today, commenting on a March 14-15 conference, "After Heparin: A Roundtable on Ensuring the Safety of the U.S. Drug Supply," in which industry and consumer experts called for changes to address the risk of counterfeit and substandard medicine:

"Americans now consume pharmaceuticals that are produced in thousands of manufacturing facilities all over the world, many in developing nations where FDA has limited ability to ensure compliance with quality standards. Although incidences of adulterated and counterfeit drugs in the U.S. are low, the impact of these events can be tragic, as we saw with contaminated heparin in 2008. That is why the Pew Health Group brought together representatives of the entire pharmaceutical supply chain, from drug ingredient manufacturers to pharmacists who interact with patients.

"During day one of the Pew conference on imported drug safety, representatives from manufacturing and consumer groups agreed to back new industry fees to cover foreign inspections. This call to action is a good start.

"Now Congress must act to give FDA much needed resources and oversight powers, including the authority to order a drug recall. Lawmakers also must take steps to ensure that pharmaceutical companies are adequately validating the quality of their suppliers—wherever they are located.

"Systemic improvement is never easy. But with a coalition like the one assembled at this conference, reform is possible."

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