Drugs

Senators Want Info on FDA Foreign Drug Inspections

With FDA pausing many foreign drug manufacturing facility inspections due to the Covid-19 pandemic, Sens. Elizabeth Warren (D-MA) and Tina Smith (D-MN) are asking the agency for information on the inspections still being held and measures being taken to protect FDA staff who conduct those inspections. In an 11/10 letter, Warren and Smith say the lack of foreign inspections is particularly concerning given the United States’ “over-reliance” on foreign drug products. Currently, they write, only 28% of facilities manufacturing active pharmaceutical ingredients and 47% of facilities manufactured finished dosage forms of drugs for the U.S. market are located in the United States.

“Without adequate inspection of the large share of many drugs and drug products coming from abroad, there may be a high risk that unsafe drugs enter circulation in the country,” the senators say. “The continued postponement of inspections of foreign manufacturing facilities could pose a danger to the public health of the United States.”

The senators say that to better understand how Congress can support the FDA mission to protect public health and ensure drug safety while also ensuring the safety of agency staff conducting inspections during the pandemic, they want to learn:

how many foreign drug inspections FDA has conducted since 3/10;
how many scheduled foreign drug inspections have been postponed or eliminated since 3/10;
the alternate approaches FDA has been using to ensure quality in cases where foreign drug inspections are postponed or canceled;
whether FDA will retroactively conduct any foreign drug inspections it was forced to skip as a result of the pandemic and when and how;
a detailed explanation of the several factors FDA considers when determining what type of inspection is considered “mission-critical” and thus should be held during the pandemic;
what factors the agency will consider in determining when it is safe to resume its full inspection schedule;
what safety measures have been implemented to protect agency employees during inspections that are still being conducted in person; and
what additional resources are needed by FDA to ensure that the agency can adequately conduct its foreign drug inspections during the pandemic.

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