Drugs

DTC Ad Drug Pricing Amendment Passes Senate

The Senate 8/23 passed a bipartisan amendment introduced by Sens. Chuck Grassley (R-IA) and Dick Durbin (D-IL) that provides Health and Human Services with $1 million to implement rules requiring pharmaceutical companies to list prices of their prescription drugs in direct-to-consumer advertisements. “The amendment helps to empower patients, promote transparency and lower prescription drug costs,” Grassley says in a release.

The amendment was part of the Defense-Labor-HHS-Education appropriations “minibus” package. “Bringing transparency to drug pricing and educating the public about the cost of their prescriptions is common sense,” Grassley says. “We’re building on what the pharmaceutical industry is already doing. In their ads, these companies educate consumers on new drugs and their side effects. This bill goes one step further by educating the public on pricing. That’s why there’s a broad coalition of support for this legislation. This is long overdue and will be a great service to health care consumers throughout the country.”

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