Drugs

Senate Bill Introduced to Curb High Drug Prices

Senators Richard Blumenthal (D-CT), Kamala Harris (D-CA), Jeff Merkley (D-OR), and Amy Klobuchar (D-MN) have introduced the Curbing Unreasonable Rises and Excessively (CURE) High Drug Prices Act today to prohibit unjustified drug price increases. The measure would give HHS the authority to block such increases and reimburse consumers who were harmed.

According to the senators, the CURE High Drug Prices Act would require pharmaceutical companies to submit justification to HHS for any price increases of:

10% or more over the preceding year;
20% or more over the preceding three years; and,
30% or more over the preceding five years.

If HHS found a price increase to be unreasonable, it could require the company to:

Reimburse consumers and payors, including Medicare and Medicaid;
Lower the price back down to its original price before the price gouging for up to one year; and,
Pay a civil penalty up to three times the excessive amount the manufacturer received as a result of price gouging.

HHS could also refer the matter to the Department of Justice for enforcement.

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