Drugs

AstraZeneca Sues FDA Over Pediatric ‘Carve Outs’

AstraZeneca filed suit 6/27 in DC federal court challenging FDA’s interpretation of statutes and regulations that (i) prohibit a generic drug from being marketed unless it includes all pediatric information appearing on the corresponding brand-name drug label, and (ii) allow generic drug manufacturers to “carve out” or omit certain labeling for which the brand-name drug manufacturer has marketing exclusivity. At issue, is the upcoming approval of 10 generic applications for a copies of the company’s blockbuster cholesterol-lowering Crestor (rosuvastatin calcium), with approval coming as early as 7/8 for some of the submissions.

AstraZeneca argues (see complaint) that it currently has orphan drug marketing exclusivity for Crestor’s use in treating a rare and serious pediatric “orphan” disease known as homozygous familial hypercholesterolemia (HoFH). The orphan drug exclusivity, it says, should preclude FDA from granting final approval for generic rosuvastatin applications until 5/2023.

AstraZeneca also argues that in 2015 the agency began interpreting statutes and regulations in a way that broadens generic drug manufacturers’ ability to carve out pediatric labeling in situations where the brand-name manufacturer has exclusive marketing rights. This interpretation, according to AstraZeneca, can be found in a 4/2015 letter to Otsuka. “FDA’s 2015 interpretation is unlawful,” the company says. “FDA’s pediatric-labeling regulations impose a categorical rule: A generic drug must include all pediatric labeling approved for the corresponding brand-name drug. Although Congress has enacted a handful of narrow and carefully targeted exceptions to that categorical rule, none of those exceptions (also known as carve out authorities) provides a valid basis for FDA’s 2015 Interpretation.”

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