Drugs

Senators Want to Study Foreign Drug Supply Investment

Sens. Marco Rubio (R-FL) and Elizabeth Warren (D-MA) have introduced legislation directing the Federal Trade Commission and the Treasury Secretary to study the United States’ over-reliance on foreign countries and the impact of foreign direct investment on the U.S. pharmaceutical industry and DNA analysis industries. A statement says the U.S. “relies heavily on foreign nations for its supply of drugs and pharmaceutical products. Today, experts estimate up to 80% of the active pharmaceutical ingredients … are imported from abroad. This over-reliance leaves our supply chain of critical drugs used by millions of Americans vulnerable to disruption, whether by accident or by design.”

The legislation would require the FTC and Treasury Department to provide Congress with a report on:

how over-reliance on foreign countries for pharmaceutical products affects the U.S. supply chain and domestic manufacturing capacity;
how foreign investment from abroad affects the nation’s ability to produce drugs, as well as their key components;
how foreign direct investment in U.S. genome sequencing technologies affects domestic capacity to sequence or store DNA; and
the number of foreign investment transactions in the drug industry and the sequencing or storage of DNA in the U.S. that the Treasury Department Committee on Foreign Investment in the United States has reviewed in the past 10 years.

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

Read more

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