The Food and Drug (FDA) Commissioner Scott Gottlieb released a statementon new policies aimed to prevent the practice of using certain agency requirements to block timely generic drug entry. The release came two weeks after the FDA called outbrand pharmaceutical companies for the creation of obstacles, preventing their competitors from developing the generic version of their drug, reported BioSpace.1
Gottlieb says that FDA’s Risk Evaluation and Mitigation Strategy (REMS) requirements are being abused. Brand drug makers are able to use REMS to restrict the sale of their drugs to generic manufactures.
Another way the REMS requirements are being abused occurs when a generic drug manufacturer seeks FDA approval and market entry.
FDA addresses this issue in its new policies: “Brand and generic drug makers are required to develop a single shared REMS program when a generic drug seeks approval and the brand drug has a REMS associated with it. This requirement applies when a generic drug applicant wants to market a generic version of a drug that has REMS with certain requirements or activities known as “Elements to Assure Safe Use (ETASU).” The current law requires that both brand and generic companies use a single, shared system REMS, unless FDA waives that requirement and permits the generic drug to use a separate, comparable REMS program.”1
New Recommendations
The first new recommendation is titled “Development of a Shared System REMS.” It describes general principles to assist sponsors. The ultimate goal is to improve clarity and efficiency for shared system REMS.
The second recommendation is titled, “Waivers of the Single Shared System REMS Requirement.” The guidance describes the process by which the FDA will use to consider waiving the single shared system requirements. In other words, the generic company may be allowed to use a comparable aspect of the ETASU if FDA declares that forming a single shared system is overly burdensome.
FDA stated, “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 concluded, “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.”1
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