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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
Senator Sherrod Brown (D-Ohio), member of the Senate Health, Education and Labor Pensions (HELP) Committee, is requesting additional information from the US Food and Drug Administration and the pharmaceutical industry, concerning the regulation and practice of outsourcing.
Washington, DC (June 12)-Senator Sherrod Brown (D-Ohio), member of the Senate Health, Education and Labor Pensions (HELP) Committee, is requesting additional information from the US Food and Drug Administration and the pharmaceutical industry, concerning the regulation and practice of outsourcing. The request follows a Senate HELP Committee hearing on drug safety in April.
“It is no coincidence that drug ingredients produced in countries with weak safety standards are often contaminated,” said Brown in a prepared statement. “The FDA must immediately review pharmaceutical outsourcing and make necessary changes to keep American consumers safe.”
In a letter dated June 12, 2008, Brown requested from Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, additional information on the volume of outsourced drug ingredients, the added cost of regulating outsourced ingredients, and the bearer of these costs. Woodcock had testified before the Senate HELP Committee hearing in April.
Specifically, Brown asked FDA to supply estimates of the volume of pharmaceutical ingredients outsourced by US drug manufacturers to China and other countries “with weaker drug-safety regimens than those of the US.” He also requested estimates for “the incremental annual cost of protecting the public from tainted pharmaceutical ingredients produced in countries without drug-safety regimes comparable to those in the US.” Brown further asked that Woodcock offer her opinion on the best means of holding drug companies accountable when they outsource.
Brown also directed a letter to Gerald Migliaccio, vice-president of quality at Pfizer (New York), who testified at the April Senate HELP Committee hearing that Pfizer outsources 17% of its active ingredients and drug-product manufacturing. Brown requested additional information on the following:
In his letter to Pfizer, Brown said that pharmaceutical outsourcing raises several important issues. He cited “the increased risk associated with drug components manufactured in countries with notoriously weak and unenforced drug-safety standards…; the negative impact of pharmaceutical outsourcing on US jobs and US communities…; [and] the fact that despite paying a steep price for pharmaceutical outsourcing, our nation still pays the highest prices in the world for prescription drugs.”
Read the full text of Brown’s letters to FDA and Pfizer.
Read Pfizer’s testimony to the Senate HELP committee on April 24, 2008.