Drugs

Cassidy Wants Info on Orange Book Listing Requirements

Sen. Bill Cassidy (R-LA) is asking FDA to explain why it has failed to provide clarity to drug manufacturers on properly listing their products’ patents in the Orange Book. In a 9/30 letter to FDA commissioner Robert Califf, Cassidy says that for decades, brand and generic drug manufacturers have struggled with how to list patents for the device parts of drug/device combination products in the Orange Book.

“Despite Congress’ clear charge to FDA to set the rules for listing patents in the Orange Book, FDA has been absent,” Cassidy writes. “The agency has refused to provide needed clarity on listing patents for drug/device combination products…. Meanwhile, the Federal Trade Commission (FTC), with FDA’s apparent encouragement, has filled the vacuum left by FDA. FTC has encroached on FDA’s jurisdiction by policing Orange Book listings under antitrust law…. FDA’s continued silence on this issue is untenable, and patients ultimately stand to benefit through clarity on these requirements.”

Cassidy asks for answers to these questions:

the status of any work product from an FDA multidisciplinary working group on patent listing created in 1/2022;
the cumulative result of FDA efforts through the working group and the solicitation of comments through a public docket;
FDA’s stand on the need to provide more clarity about the listing of patents for drug/device combination products and why the agency has failed to clarify through some means the scope of patents that must be listed;
the pros and cons of listing patents related to the device constituent of drug/device combination products;
FTC’s actions related to Orange Book patent listings;
whether a 30-month stay for a drug has ever hinged on a patent for a device constituent of a drug/device combination product and details of any such situation;
how often (with example details) FDA has granted tentative approval to an ANDA where the sole obstacle to full approval was a patent for a device constituent of a drug/device combination product;
if FDA has remained silent due to negative unintended consequences that could come from restricting patent listings, why it has encouraged FTC to take enforcement action; and
whether Congress should amend the Federal Food, Drug, and Cosmetic Act to clarify the patent listing requirements.

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