The buzzword at a Sept. 14 hearing on securing the pharmaceutical supply chain was one not often heard in the current congressional climate: “consensus.” There was general agreement among witnesses that our laws are outdated in a world where the drug supply chain stretches around the globe through a network of suppliers in countries such as India and China.
In 2007 and 2008, the pharmaceutical industry and regulators got a wakeup call when a batch of the blood thinner heparin was adulterated by a Chinese manufacturer, sickening and even killing American patients who took it.
“I believe that adulterated drugs coming into this country is criminal. I think it’s a form of murder,” said Sen. Barbara Mikulski of Maryland. “So we’ve gotta get real, we’ve gotta get serious, and we have to have a sense of urgency.”
The hearing, organized by the Senate Health, Education, Labor and Pensions Committee, is a part of lawmakers’ fact-finding effort for the 2012 reauthorization of legislation on drug user fees.
In testimony, the Generic Pharmaceutical Association supported Health and Human Services Secretary Kathleen Sebelius’ call for congress to update the U.S. Food and Drug Administration’s authorities.
“GPHA is in agreement with the secretary and FDA that it is essential to modernize the laws governing the U.S. supply chain,” Gordon Johnston said. “As noted in my opening remarks, the responsibility of ensuring safety is a shared one that rests with all of us in industry and not just FDA.”
Johnston also referenced the Pew Health Group’s report, After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs: “As my colleagues at Pew noted in their recent report, it’s also critical that manufacturers continue to go beyond good manufacturing practices and assure that their supplier qualification tools are used as well as a risk based assessment to assure the quality and integrity of suppliers abroad.”
In his testimony, Allan Coukell, director of medical programs at Pew Health Group used a photograph of a factory in squalor to demonstrate the horrible conditions of facilities where some drug ingredients are manufactured.
“A couple of speakers have mentioned the need for manufacturers themselves to ensure supplier quality. That’s crucial,” Coukell said. “Sometimes substandard facilities sell to so-called “show” factories – a high-quality facility that sells product that it did not make itself.”
Coukell quoted a China-based pharmaceutical auditor who said American and European companies are misinformed about the identity of all, or part, of their supply chain more than a third of the time.
Potential solutions discussed included strengthening industry quality management, increasing regulatory oversight, and making sure the FDA has the tools it needs, such as the ability to order the recall of drugs.
Sen. Michael F. Bennet of Colorado noted how the testimony at the hearing reflected the notion that updated policies are a necessity.
“I find remarkable the degree of consensus around a lot of the issues we face,” Bennet said. “The lack of a regulatory regime that reflects reality is bad for our consumers and bad for our business. I think that’s why we need to be urgent in fixing it.”
-- Marcia Hams, Community Catalyst, Director of Prescription Access and Quality