Drugs

Learn from Pandemic to Improve FDA Foreign Inspections: GAO

The Government Accountability Office (GAO) says FDA needs to use lessons it has learned during the Covid-19 pandemic to improve its foreign drug inspection program, including efforts to identify alternative mechanisms to satisfy foreign inspection requirements and ways to address its growing backlog of inspections. In testimony prepared for delivery 3/4 to the House Appropriations Committee subcommittee that oversees FDA, GAO healthcare director Mary Denigan-Macauley says her organization found in 12/2019 that FDA faced many of the same challenges overseeing foreign establishments that were identified over the last two decades.

“Subsequently, the outbreak of Covid-19 has added a layer of complexity,” she will say.

Denigan-Macauley will testify that FDA has used alternative inspection tools to maintain some oversight of drug manufacturing quality while inspections are paused due to the pandemic. Such tools, her testimony says, including relying on inspections conducted by foreign regulators, requesting and reviewing records and other information, and sampling and testing drugs.

“Even before the Covid-19 pandemic,” she is expected to say, “FDA faced persistent challenges conducting foreign inspections. GAO found in 12/2019 that there continued to be vacancies among the investigators who conduct foreign inspections. GAO further found that FDA’s practice of preannouncing inspections up to 12 weeks in advance could give manufacturers the opportunity to fix problems ahead of the inspection and raised questions about their equivalence to domestic inspections. In light of Covid-19, FDA is now preannouncing both foreign and domestic inspections for the safety of its staff and manufacturers. GAO also found that language barriers can create challenges during foreign inspections as FDA generally relies on the establishment for translation services.”

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