Harkin Opening Statement at HELP Hearing, “Securing the Pharmaceutical Supply Chain”
*As Prepared for Delivery*
“As part of our ongoing process to reauthorize the FDA user fee legislation this congress, we have convened this hearing to examine the safety and integrity of our pharmaceutical supply chain. Few issues are more important to the health and safety of Americans than the integrity of our drug supply. The safety of our medicines has a profound effect on the health and security of our country, and we must have confidence that our system of oversight is up to the task of protecting our families.
“In today’s increasingly global economy, most of the key ingredients used in the drugs prescribed by American doctors and consumed by American families are produced overseas. About 80% of the active ingredients found in U.S. pharmaceutical products come from abroad, as do about 40% of finished drugs. This trend is projected to continue and increase, with more and more of our medicine cabinets being stocked with products from countries like India and China with less robust regulatory systems than our own. Our challenge is to embrace the promise of this increasingly global economy while still making sure we protect American patients.
“The profound interests at stake are highlighted for us by tragic examples of American patients who have taken adulterated drug products, such as the 150 U.S. patients who died in 2007 after taking contaminated Heparin. These appalling examples remind us that the need for vigilance is high and the costs of failure are staggering. Parents in my state of Iowa shouldn’t have to worry that the medicine they give their sick children is substandard or contaminated.
“Weaknesses in our pharmaceutical supply chain not only affect the health of American patients, but also the health of American businesses. By holding foreign actors to the same standards as those in the US, we guarantee a level playing field. U.S. companies that source and manufacture drugs in this country should not be placed at a competitive disadvantage by foreign firms that operate with less oversight and sell substandard ingredients into this country at reduced prices.
“We must have an honest conversation about how globalization impacts the integrity of our drug supply and what must be done to ensure our safety. When FDA’s authorities were first designed and enacted, our production methods were based at home. FDA’s primary authorities to ensure the quality of our drugs -- strict oversight of domestic manufacturers coupled with the ability to interdict illegal drugs at the border -- were well suited to the manufacturing practices of the time. But that was nearly 100 years ago! We don’t live in the same world as we did a century ago, and our drug safety controls have failed to adequately progress.
“FDA and Customs have tried to increase their vigilance to keep pace with the increasingly global nature of our supply chain, but FDA does not have the authority and flexibility it needs to make sure that foreign facilities adhere to the same quality standards as U.S. facilities. Some domestic companies have tried to fill that gap by adopting robust Quality Control practices that include inspecting their overseas suppliers, but others have not. The result is a supply chain rife with gaps.
“Last year, this Committee took an important bipartisan step to modernize our food safety system, giving FDA the tools necessary to hold foreign food importers and producers to the same safety standards as those in the U.S. Now we have to bring our drug supply system into the 21st century.
“This morning, we will explore systemic concerns associated with the drugs and drug ingredients that are imported into the United States from abroad, and we will learn about the new challenges that both the FDA and American pharmaceutical companies face in navigating the global economy. As we begin the critical discussion on how to modernize our drug supply system, we’ll hear from several expert witnesses who approach this important issue from a variety of perspectives. I thank you all for being here and look forward to your remarks. And I look forward to continued bipartisan cooperation with my colleague, Ranking Member Enzi, who has worked closely with me on scheduling this hearing and who has devoted considerable energy to examining this issue.”
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