Drugs

FDA Steps to Reduce REMS Generic Drug Blocks

FDA is publishing two draft guidances intended to reduce innovator drug companies’ ability to use risk evaluation and mitigation strategy (REMS) programs to block time entry of generic drugs. In a statement (contains links to the guidances), FDA commissioner Scott Gottlieb says REMS can be exploited in two ways. At the front end of the drug development process, they can be used to restrict sale of drugs, keeping needed product out of the hands of generic companies. At the end of the process, after a generic drug seeks FDA approval and market entry, negotiations can drag on to develop a shared systems REMS for a generic drug associated with a branded drug that already has a REMS.

Gottlieb says the new guidances are to address the negotiating of a shared REMS. “While FDA recognizes that these negotiations are an important step in the formation of a shared system REMS,” he says, “the agency is also committed to making sure that REMS programs maintain their role in serving public health. The REMS shouldn’t become a tool that drug companies can use to delay or block competition from generic products or hinder their ability to enter the market.”

The first draft guidance, Development of a Shared System REMS, gives general principles and recommendations to assist sponsors in developing the programs. It is intended to improve the clarity and efficiency for developing shared system REMS.

The second draft, Waivers of the Single, Shared System REMS Requirement, describes when and how the agency will consider waiving the single, shared system requirement, and how generic applicants can request a waiver.

“We believe that by making the process for developing a shared system REMS more efficient, we’ll discourage brand drug makers from using REMS as a way to block generic entry and help end some of the tactics that can delay access,” Gottlieb says. “We’re also going to be clearer about the circumstances when we’ll issue waivers to let the generic firms develop their own REMS program. Our safety programs shouldn’t be leveraged as a way to forestall market entry after lawful IP has lapsed on a brand drug.”

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

Read more

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