Drugs

FDA Denies BI Parenteral Drug Petition

FDA has denied a 12/2/2020 Boehringer Ingelheim petition asking that the agency:

interpret the term “strength” in a section of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) relating to parenteral solutions to mean the total drug content in the relevant container; and
revise applicable guidance documents to be consistent with such an interpretation.

In its response, the agency says it:

disagrees with the company’s assertion that FDA interpreted “strength” of a liquid parenteral drug product to mean only the total drug content at the time the BPCIA was passed;
disagrees with the company’s statement that when the BPCIA was passed “strength” and “concentration” had distinct, non-overlapping meanings and disagrees with the assertion that FDA’s interpretation of the “strength” of a parenteral solution for purposes of the act did not include the concentration of drug substance before 2016; and
disagrees with the BI assertion that the interpretation of “strength” is arbitrary and capricious, maintaining instead that it is scientifically justified.

FDA also rejects BI’s assertion that if its other arguments fall, FDA should still use its discretion to change the policy because the total content definition better promotes the goals of the BPCIA and there are no countervailing regulatory interests that outweigh such a benefit.

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