FDA Policy/General

Drug Safety Monitoring Hurt by FDA Staff Cuts: Post

FDA staff reductions in force appear to be hurting programs that track drug safety, according to anonymous sources who spoke with Chemical & Engineering News. A fired employee told the newsletter that “there’s a handful of employees desperately keeping the lights on.”

The report says the CDER Division of Drug Information (DDI), which lost between 75% and 90% of its staff, was the first point of contact for safety concerns from consumers, doctors, pharmacists, and industry whistleblowers, along with responding to a wide variety of safety- and access-related requests from the public.

The post says the cuts have created issues for healthcare providers, quoting an academic medical center pharmacist and bioethicist speaking about confusion over which Risk Evaluation and Mitigation Programs remain active.

In a 4/17 interview with broadcast personality Megyn Kelly, FDA commissioner Martin Makary shared a vision of heightened oversight after drugs are marketed so safety issues will appear more quickly. The post says fired DDI staff conducted such post-approval safety monitoring. The fired staff said the remaining staff are struggling to keep up with inquiries and cannot update databases such as the REMS program registry.

The newsletter reports DDI also was responsible for maintaining the MedWatch adverse event reporting program and handled about 42,000 phone calls and 30,000 emails from the public last year. HHS did not respond to a C&EN request for comment on whether MedWatch is still operational. It also reportedly did not respond to a list of detailed questions from the newsletter about the overall impact of cuts on DDI.

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