Drugs

Staff Cuts Lead to Drug Data Gaps: Sources

Several anonymous current and former FDAers say the reductions in force the agency has experienced have led to key databases not being maintained and updated, meaning that healthcare professionals are unable to get basic information about drugs they prescribe. The staffers spoke with Axios for an online article.

A laid-off FDAer told Axios that the drug database has a growing amount of missing information. The staffer said most database entries since the 4/1 job cuts are missing labeling information, including indication, dosing instructions, and side effects.

A still-employed staffer reported that the Drug Registration and Listing database hadn’t been updated for a period until FDA convinced a few laid-off staffers to return part-time to help. Their jobs are set to be eliminated on 6/2. “Once June happens, we have no idea what the plans are for updating these things,” the official said.

In addition to the lack of staff, the sources said, problems are arising due to the administration’s requirement that all communications go through a central HHS office. Thus, consumer alerts that might have taken several hours to post can now be pending for weeks, as happened with a recent alert about a supplement that was found to be potentially harmful due to unlisted drug ingredients.

The article says the staff shortage hasn’t prevented drug recalls from being posted on time. However, it says, if a company were to refuse a voluntary drug recall of a defective product, it would require an FDA multidisciplinary team to write, vet, and post a warning. “It’s not a question of if that’s going to happen,” the employed staffer told Axios. “It’s a matter of when that’s going to happen. And then what do we do from there? Because, to piece it all together without the staff in place, is just an enormous lift.”

Axios says HHS did not respond to its request for comment.

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