Drugs

Generic Drug Industry’s Trade Agreement Concerns

FDA has released a 10/17 letter from the Association for Accessible Medicines raising concerns about the U.S.-Mexico-Canada Free Trade Agreement. “The trade agreement, if left in its current form, will decrease competition, inevitably leading to increased drug prices in the United States, harming patients, job creators, workers, and taxpayers,” the letter says. “Furthermore, several provisions within the agreement are inconsistent with U.S. law, and if left unchanged could lead to inappropriate changes in U.S. law or cause the United States to be in violation of the agreement on day one of its enactment.”

The letter says the association supports the administration’s efforts to lower drug prices and supports trade agreements that balance the need for medical innovation and enhanced access to medicines. It particularly calls attention to concerns that the agreement’s intellectual property rights chapter almost uniformly protects and extends patent monopolies of brand name companies.

The association provides changes it would like to see in the agreement.

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