Sen. asks CDER for pharmaceutical accountability options

WASHINGTON Sen. Sherrod Brown, D-Ohio, is asking Center for Drug Evaluation and Research Director Janet Woodcock for the best ways to hold pharmaceutical companies accountable for contaminated drugs when they outsource production of ingredients to other countries.

“It is no coincidence that drug ingredients produced in countries with weak safety standards are often contaminated,” said Brown in a statement. “The FDA must immediately review pharmaceutical outsourcing and make necessary changes to keep American consumers safe.”

Brown asks Woodcock in a June 12 letter to expand on her late-April testimony at a Senate Health, Labor, Education and Pensions Committee hearing in which she said the industry needs to be held accountable for the quality of drugs it markets. 

The hearing was held to discuss the heparin contamination. The contamination has been linked to numerous serious adverse events, including deaths. Brown also requests an estimate of the additional incremental costs to protect the public from “tainted pharmaceutical ingredients produced in countries without drug safety regimes comparable to those in the U.S.” Additionally, he wants an estimate of the volume of drug ingredients outsourced by U.S. firms to Chinese manufacturers, as well as producers in other countries with weaker regulations.

In the letter, Brown says addressing outsourcing trends needs to be considered as an emerging challenge for the FDA. “The drug industry is dealing our nation multiple blows by outsourcing drug ingredients; it is compromising U.S. drug safety and undermining U.S. jobs. Despite paying a steep price for pharmaceutical outsourcing, our nation still pays the highest prices in the world for prescription drugs. There is no evidence that outsourcing is translating into any savings for patients in the U.S,” he writes.