Drugs

House Passes 2 Bills on Orange and Purple Books

The House has passed two bipartisan bills that would make updates to FDA’s Orange Book and Purple Book to improve accuracy and transparency of the two databases that guide development decisions for generic and biosimilar manufacturers. They are:

H.R. 1503, the Orange Book Transparency Act of 2019, from Reps. Robin L. Kelly (D-IL) and Brett Guthrie (R-KY). It is intended to codify the current requirement to list drug substance patents, drug product patents, and method-of-use patents; and allows the listing of other patents at agency discretion. It further requires manufacturers to notify FDA of any court decision finding a patent invalid and requires that FDA remove those patents from the Orange Book to ensure the database is up to date.

H.R. 1520, the Purple Book Continuity Act of 2019, from Anna G. Eshoo (D-CA) and Rep. Michael C. Burgess (R-TX). It is intended to codify the requirement to list: name of biologic; date of licensing; studies necessary for biosimilar applications; updates every 30 days; patents disclosed during “patent dance”; and withdrawal or suspension of licensure. In addition, the bill requires FDA to report recommendations of what patents should be listed in the Purple Book going forward. The legislation also increases the Purple Book’s utility by requiring it to be made public in a more usable format.

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