Drugs

Mixed Stakeholder Views on Orange Book Listings

As required by the Orange Book Transparency Act of 2020, the Government Accountability Office (GAO) has reviewed FDA Orange Book patent listings for drug/device combination products, including the listings’ implications for generic products. In a report, GAO says it interviewed 15 stakeholders on (1) how Orange Book patent listings affect the entry of generic drug/device combination products into the market; (2) FDA’s role overseeing the Orange Book; and (3) proposals for improving Orange Book patent listings.

All 15 stakeholders agreed that the Orange Book may help generic drug sponsors identify relevant patents when making product development decisions. However, GAO reports, there was no consensus on whether the patent information listed in the Orange Book may delay the entry of generic drug/device combination products into the market.

Six of the interviewed stakeholders said FDA’s current role in overseeing the Orange Book is sufficient and the agency should not be evaluating patents for validity or quality. However, seven stakeholders said FDA should have a more active role to ensure the patent information in the Orange Book meets listing requirements, such as by substantively reviewing patent scope to ensure patents meet listing requirements.

Finally, the stakeholders identified 13 different proposals to improve patent listings. Some 13 of the stakeholders agreed it would be helpful for FDA to clarify which device-related permits should be listed in the Orange Book. However, the report says, the stakeholders identified widely varying criteria for which device-related patents were appropriate to list.

GAO reports that FDA is planning to establish a multidisciplinary workgroup to evaluate whether additional clarity is needed regarding patent information that should be included in the Orange Book. “While FDA officials said that resource challenges had prevented them from developing workgroup timelines or identifying the members, they hoped to make those decisions soon,” it says.

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’

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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

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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