Drugs

Trump Salutes FDA During State of the Union Address

President Donald Trump acknowledged FDA and its record approvals last year in his 1/30 State of the Union address. “To speed access to breakthrough cures and affordable generic drugs, last year the FDA approved more new and generic drugs and medical devices than ever before in our history,” he said to rousing applause.

The president urged Congress to advance “right-to-try” legislation to allow patients with terminal conditions to have access to unapproved experimental treatments. “People who are terminally ill should not have to go from country to country to seek a cure,” he said. “I want to give them a chance right here at home.” So far, 38 states have right-to-try laws on their books, and the Senate has passed a bill but the House has not moved any related bill forward.

On drug prices, Trump reiterated his frustration with lower cost options abroad and skyrocketing costs in the U.S. “One of my greatest priorities is to reduce the price of prescription drugs,” he said. “In many other countries, these drugs cost far less than what we pay in the United States. That is why I have directed my Administration to make fixing the injustice of high drug prices one of our top priorities. Prices will come down.”

And the president pledged to increase efforts to combat the growing opioid and drug addiction crisis in the U.S. “My Administration is committed to fighting the drug epidemic and helping get treatment for those in need,” he said. The call resonated with newly appointed HHS secretary Alex Azar, who immediately tweeted: “We declared an unprecedented #PublicHealth Emergency, bringing a new level of coordination and commitment to the issue.” Public health critics have been disappointed with the Administration’s efforts, calling the declaration “lip service” for its lack of resources. Meanwhile at FDA, commissioner Scott Gottlieb has staff scurrying to address prescription opioid abuse with multiple efforts currently underway.

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