Drugs

Improve and Pass H.R. 3: Public Citizen

Public Citizen says H.R. 3, the House Democratic leadership’s bill to lower prescription drug prices, should be improved and then passed. In a statement responding to a Bloomberg News publication of a leaked version of the bill, the advocacy group says it is an “ambitious plan” that “if adopted should generate major savings for the U.S. government and help many, perhaps millions, of people get medicine they need but cannot now afford.”

Noting that Democratic staffers have said the leaked summary is an outdated draft and that the specific content is still being negotiated, Public Citizen says that compared to earlier reports, the leaked summary envisions the U.S. government taking greater responsibility for getting a better deal on medicine prices. “It casts out arbitration in favor of direct government negotiations,” it says. “It imposes tough penalties when obstinate drugmakers won’t play ball. And it means to achieve better prices not only for Medicare, but for all payers.”

The group also says there are important limits on the leaked plan’s capacity to make medicine affordable. “The plan as articulated does not restrain how much we pay for newly launched drugs, and patients who use expensive medicines that do not qualify for negotiation may still be at the mercy of pharma’s price gouging,” the statement says. “The plan may rely too heavily on prices abroad, which derive from monopolies just as they do here, rather than providing a fresh opportunity to establish fair prices related to real research investments and priorities. We hope these issues can be remedied in committee, in part by incorporating the power of generic competition when drugmakers refuse to agree to a reasonable price.”

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