May 01, 2008
Kennedy urges overseas Rx database
Sen. Edward Kennedy (D-MA) says the FDA should build databases to enable it to determine where drug companies obtain their ingredients and what they are doing to ensure the ingredients are pure and potent. And he is asking drug trade associations to urge their members to provide information to the FDA.
Kennedy suggested the FDA action in March letters to FDA commissioner Andrew von Eschenbach and the CEOs of PhRMA, Biotechnology Industry Organization, Generic Pharmaceutical Association and Consumer Healthcare Products Association.
Kennedy said his recommendation comes as a result of the deaths of 19 people from reactions to contaminated Heparin. In his letters, Kennedy said it “appears likely” that hypersulfated chondroitin sulfate was “added intentionally to protect the sales of Heparin. Pigs are the source of Heparin but are in short supply in China because of rampant disease, which may have led to use of the contaminant.”
He noted that 80% of the active ingredients in US drugs are derived from overseas sources, with 40% from China and India.
Kennedy also told von Eschenbach he believes those responsible for the Heparin incident should be held accountable and urged the FDA to work with the Justice Department in its investigation and to pursue enforcement actions.
Meanwhile, Sen. Charles Schumer (D-NY) has said he and Kennedy are introducing legislation to increase FDA funding for foreign inspections and require overseas monitoring.