Drugs

Senate Bill Introduced on Drug Shortages

Democratic U.S. Senators Ben Cardin (D-MD), Tina Smith (D-MN), and Richard Blumenthal (D-CT) have introduced legislation that would give FDA and Centers for Medicare and Medicaid Services (CMS) additional authority to address drug shortages.

The bill, the Drug Shortages Prevention and Quality Improvement Act (S 2586), “would address some of the root causes of drug shortages and extend additional tools the FDA and CMS can use to mitigate this growing problem,” according to a release. The senators say the measure would:

Extend shelf-life dates for essential drugs by requiring manufacturers to update their products’ shelf life to the longest supported expiration date and allow FDA to issue civil monetary penalties to manufacturers who fail to comply.
Require reporting on increases in demand for a drug no later than 30 days after the manufacturer has knowledge of an increase in drug demand.
Provide FDA with penalty authority to levy fines against manufacturers that fail to appropriately report a permanent discontinuance in or interruption of the manufacture of a drug.
Award grants for advanced manufacturing upgrades, particularly for generic sterile injectable drugs, may not have the resources or lack incentives.

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