Drugs

OIG Hit FDA Accelerated Approvals

The HHS Office of Inspector General (OIG) semiannual report covering the period 10/1/2024 to 3/31 says the OIG concluded that FDA’s use of its accelerated approval pathway raised concerns in three of 24 drugs reviewed. The report says OIG identified instances in which FDA (1) approved drugs despite concerns from its reviewers and/or advisory panels; (2) deviated from recommended practices by evaluating analyses not included in the sponsor’s original plan; and (3) did not properly document meetings held during the review process.

“Two of the three drugs that raised concerns are now off the market,” the report says, “and completion of the confirmatory trial for the third drug has been delayed.”

The report says the OIG’s total monetary impact during the reporting period was $16.61 billion, including $3.51 billion in investigation receivables, $451 million in audit receivables, and $12.65 billion in potential cost savings. It says the return on investment for OIG is $11 for every $1 spent, based on a three-year rolling average of expected recoveries and receivables from OIG work.

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

Read more

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