Drugs

House Members Seek FDA Info on Complex Generics

Six bipartisan House Energy and Commerce Committee leaders 1/17 wrote FDA commissioner Stephen Hahn seeking information on the agency’s processing of complex generic drugs. Their four-page letter said they were interested in lowering the costs of prescription drugs generally, but the number of complex generic drugs being approved by FDA “is lagging.” They wrote that “The length of time leading to the approval of some recently approved complex generics raises questions of whether additional actions may be necessary to encourage the development of these products.”

They asked Hahn to provide the following information:

A list of all complex generic drugs approved by FDA since October 1, 2016, including the date of the first submission, the dates of other milestones (e.g., issuance of complete response letters, subsequent submissions), and the date of approval.
Copies of any after-action reports or internal reviews related to the review process of complex generic drugs approved since October 1, 2016.
The number of pre-ANDA meeting requests that FDA has received each year since the program was launched, the number of pre-ANDA meetings that FDA has held each year, and the number of ANDAs that have been submitted for products discussed during these meetings.
The number of product development meeting requests for complex products, as defined in the GDUFA II commitment letter, that FDA has received each year since 8/1/17; the number of product development meeting requests for complex products that FDA has held each year; and the number of ANDAs that have been submitted for products discussed during these meetings.
A list of product-specific guidances FDA has published for complex drug products, including the number of such guidances that are draft and the number of such guidances that are final.

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