Drugs

Sen. Scott Bill to Require Country-of-Origin on Rx Labels

Sen. Rick Scott (R-FL) has introduced legislation that would require prescription drug labels in the U.S. to disclose where drugs and their active pharmaceutical ingredients are manufactured, aiming to increase transparency in a supply chain that relies heavily on overseas production. The bill, the Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, would mandate country-of-origin labeling for both finished prescription drugs and the active pharmaceutical ingredients, or APIs, used to make them. Current federal labeling rules do not require public disclosure of the countries where APIs or finished products are manufactured, Scott says.

Scott said the lack of labeling leaves patients, pharmacists, and health care providers with limited visibility into the origins of many commonly used medicines. Many generic drugs and APIs are produced outside the U.S., particularly in China and India, according to the senator.

The proposal builds on work Scott has led as chairman of the Senate Special Committee on Aging, including an investigative report and multiple inquiries to federal agencies and pharmaceutical companies examining U.S. reliance on foreign-manufactured generic drugs. Scott has also framed the measure as a way to reduce U.S. dependence on foreign drug manufacturing and encourage domestic production.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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