Drugs

Orange Book Listings Need Clarification: Comments

Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should clarify that patents claiming the device constituent of a drug-device combination product approved in an NDA or a component thereof are drug product patents subject to Orange Book listing requirements. PhRMA states its position in its response to an agency request for comment on the listing of patent information. The comment letter also says that patents claiming a method of using a device constituent or component thereof in an NDA-approved single-entity combination product are subject to Orange Book listing requirements.

The trade group also says that patents ought not to be excluded from Orange Book listing simply because they relate to a risk evaluation and mitigation strategy. And PhRMA recommends that FDA consider patent listing issues for digital health technologies after further development of the regulatory framework for those products.

In its letter, the Biotechnology Innovation Organization commends FDA’s efforts to provide additional clarity on the types of patents subject to listing in the Orange Book and the agency’s acknowledgment that changes to current patent listing practices could have an impact on drug product development. “This is an important topic that, in certain respects, could benefit from further guidance and clarity from FDA,” the association writes.

Finally, the law firm of Epstein Becker Green tells FDA that the ability to list patents for digital health products in the Orange Book “can support FDA-approved claims about the benefits of specific smart products and digital applications when used with specific drug product formulations. This will spur digital health innovation that helps patients, the same way that the incentive of listing patents motivates all pharmaceutical innovation.”

The firm also says that if an FDA-approved drug labeling claim regarding the use of a smart product with a digital application is also the subject of a method of use patent claim (such as the use of a digital application that supports adherence), it should be listable in the Orange Book. And, it says, if an NDA includes the use of smart products including digital applications, the book should reflect that the product is not therapeutically equivalent to non-digitally enhanced products that have the same drug formulation.

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