July 14, 2008
Drug company outsource probe sought
Sen. Sherrod Brown (D-OH) wants the FDA to evaluate how it protects the American public from drug products containing tainted, outsourced ingredients. Brown says that in a recent Senate committee hearing, FDA director of drugs, Janet Woodcock, testified that US drug companies outsource operations to take advantage of weaker drug safety standards in some foreign countries.
In a subsequent letter to Woodcock, Brown asked her to provide the volume of pharmaceutical ingredients outsourced by US drug manufacturers to China and other countries with weaker drug safety regimes than that of the US and 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. He also asked Woodcock for her opinion on the best means for the FDA to hold accountable drug companies that outsource ingredient production.
“It is no coincidence that drug ingredients produced in countries with weak safety standards are often contaminated,” Brown said. “FDA must immediately review pharmaceutical outsourcing and make necessary changes to keep American consumers safe.” Brown also wrote to Pfizer VP of quality Gerald Migliaccio, who testified before the same Senate committee as Woodcock, that 17% of Pfizer's active ingredients and drug product manufacturing are outsourced.