Drugs

Orange Book Modernization Act Codifies Current Practices: Analysis

Attorneys Sara Koblitz and Kurt Karst (Hyman, Phelps & McNamara) say the Orange Book Modernization Act signed by President Trump 1/5 primarily codifies existing FDA patent listing practices. Writing online in their firm’s FDA Law Blog, Koblitz and Karst say that although there is little new in the act, it represents Congress’ interest and attention to Orange Book reform, something they say FDA has been essentially avoiding for the last 15 years.

The act specifies the patent information that must be submitted and listed in the Orange Book, clarifies that canceled or invalid patents must be timely removed, directs the agency to solicit public comments on information listed in the Orange Book and issue a report to Congress, and instructs the Government Accountability Office to study whether patents should be listed in the Orange Book at all.

The attorneys say a sentence from the 2019 House report on the legislation that was deleted from the final version raises some questions about whether FDA will change its patent publishing practices.

They conclude that while nothing in the law is revolutionary, it signals that FDA and Congress are on the same page concerning the importance of maintaining accurate and up-to-date patent information and that Congress is willing to fold Patent Trial and Appeal Board/Inter Partes Review (PTAB/IPR) decisions into the Waxman-Hatch Act. They say that could be important in the future if it becomes necessary to further incorporate PATB/IPR decisions into Waxman-Hatch for purposes of 30-month stay termination or 180-day exclusivity forfeiture.

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