Drugs

Bill to Reduce Dependence on China Drugs

Senator Marco Rubio (R-FL) has introduced a bill entitled Further Strengthening America’s Supply Chains and National Security Act to reduce America’s dependence on China for pharmaceuticals and to address related supply chain risks that lead to shortages of critical drugs.

“The COVID-19 pandemic highlighted how vulnerable America’s supply chains are,” Rubio said in a news release. “Three years later, we continue to be victims of a pharmaceutical supply chain that has been sent overseas. We cannot continue down this path; that is why I am introducing the Further Strengthening America’s Supply Chains and National Security Act to put an end to America’s dependence on other countries for key drugs.”

The legislation would:

Close a loophole created by the court decision in Acetris Health, LLC v. United States that allowed drugs with foreign active ingredients to qualify for government procurement as though they were drugs made in the U.S.
Amend FDA’s foreign inspection risk factors to improve oversight of facilities in China and other countries with questionable drug manufacturing quality standards.
Require drug makers to share more information with FDA about where pharmaceutical ingredients are sourced.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome