Drugs

Generic Policy Shop Cuts will Hurt ANDAs: Post

Hyman, Phelps & McNamara attorney Kurst Karst is raising concerns about recent staff cuts at FDA that “eradicated” the Office of Generic Drugs’ Division of Policy Development (DPD). The division’s functions are critical to the development and approval of generic drugs, he says in a 4/9 FDA Law Blog post and there is uncertainty about how the work will be handled going forward. Among other functions, the division was responsible for:

Developing product-specific guidances.
Implementing the Drug Competition Action Plan, which focused on removing barriers to generic drug development, approval, and market entry.
Publishing generic drug guidances and internal policies and procedures to fulfill FDA’s user fee commitments.
Processing voluntary ANDA withdrawals.
Managing the process of issuing Covered Product Authorizations under the CREATES Act for generic manufacturers to have access to samples of brand-name drugs not readily available through normal market channels for generic drug development.

Karst says the division also did other substantial “behind-the-scenes work” to support ANDAs and OGD generally. For example, it “worked with subject matter experts from across FDA to clarify the scientific and regulatory pathway for the transition of generic metered-dose inhalers to different propellants…,” he says.

In closing his post, Karst says “generic drug access, availability, and affordability will suffer without DPD. We can only hope that the powers that be will promptly reconsider this move.”

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