There seemed to be broad agreement at a hearing convened this week by the US Senate Health, Education, Labor and Pensions (HELP) Committee that federal drug regulators need more authority to safeguard the pharmaceutical industry’s global supply chain.
In opening remarks, HELP Committee Chairman Senator Tom Harkin (Democrat, Iowa), said: “As part of our ongoing process to reauthorize the [Food and Drug Administration] 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.”
He continued: “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 US 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.”
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