Drugs

BIMO Metrics Show Major Inspection Declines

Just-released FDA Bioresearch Monitoring (BIMO) Program metrics report for fiscal year (FY) 2021 shows substantially fewer clinical investigator (CI) inspections conducted due to Covid-19 travel restrictions.

In FY 2019 and before Covid had been detected, CDER conducted 574 CI inspections, but in FY 2021 that number fell to 327 inspections, a 43% drop in inspections. For CDRH, 126 such inspections were conducted in FY 2019 and in FY 2021 that fell to 27 — a 79% decline.

The BIMO metrics list common clinical investigator inspectional observations for 2021 as:

Failure to follow the investigational plan; protocol deviations
Inadequate and inaccurate case history records; inadequate study records
Inadequate accountability or control of the investigational product
Failure to comply with Form FDA 1572 requirements
Inadequate subject protection; informed consent issues
Safety reporting; failure to report or record adverse events
Failure to comply with 21 CFR part 56 (IRB) requirements.

Additionally, the metrics show even worse declines for inspections of institutional review boards. In FY 2019, there were 90 CDER-directed IRB inspections, but last year that had fallen to just 11 IRB inspections — a 90% decline. And CDRH fell from 37 inspections in 2019 to 15 inspections in 2021. The following are the common institutional review board inspectional observations for last year:

Failure to conduct initial or continuing review of research
Failure to have minutes of IRB meetings in sufficient detail to show attendance at the meeting; vote actions, quorum issues
Failure to conform to membership criteria listed in 21 CFR107
Failure to follow FDA regulations regarding expedited review procedures
Inadequate written procedures for prompt reporting of non-compliance, suspension or termination
Failure to prepare and maintain documentation of IRB activities; inadequate copies of research proposals and related documents

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