Drugs

Create Labeling-only NDA: Report

David McFarland

— 2 min read
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A Federation of American Scientists online report calls on FDA to create a dedicated regulatory pathway for non-manufacturers to seek approval of new indications for repurposed generic drugs. Written by three RebootRx executives, the report says one possible approach would be an extension of the existing 510(b)(2) NDA pathway to a “labeling only” 505(b)(2) NDA that could be used by non-manufacturers to seek FDA approval of new indications for well-established small molecule drugs when multiple generic products are already available.

The authors say that repurposing generic drugs is an overlooked opportunity due to a lack of market-driven incentives. “The low profit margins for generic drugs mean that pharmaceutical companies rarely invest in research, regulatory efforts, and marketing for new uses,” they say. “Nonprofit organizations and other non-commercial non-manufacturers are increasing efforts to repurpose widely available generic drugs and rapidly expand affordable treatment options for patients.”

The report says non-manufacturers find it difficult to obtain FDA approval for new uses for these reasons:

  • the need to provide the agency with chemistry, manufacturing, and controls (CMC) information;
  • providing FDA with product samples; and
  • conducting post-marketing surveillance.

While non-manufacturers could partner with a manufacturer of a drug to submit a 505(b)(2) NDA, the report says that as a practical matter that pathway is rarely attainable. “Manufacturers of marketed drug products, particularly generic drug manufacturers, lack the incentives needed to partner with non-manufacturers,” the authors write. “Manufacturers may not want to provide their CMC data or samples because it may prompt FDA inspection of their facilities, require an update to their CMC information, or open the door to product liability risks. The existing incentive structure strongly discourages generic drug manufacturers from expending any additional resources on researching new uses or making any changes to their product labeling that would deviate from the original reference-listed product.”

The article says a labeling-only 505(b)(2) NDA would enable non-manufacturers to reference CMC information from previous FDA determinations and, when necessary, provide FDA with samples of commercially available drug products. Using this approach, it says, the new indication would not be tied to a specific drug product made by one manufacturer.

“There is no inherent necessity for a new indication of a generic drug to be exclusively linked to a single manufacturer or drug product when FDA has already approved multiple therapeutically equivalent generic drugs,” it says. “Any of these interchangeable drug products would be considered equally safe and effective for the new indication, and patients could receive any of these drug products due to pharmacy-level substitution.”

The authors suggest the labeling-only pathway could be implemented through an FDA guidance interpreting the current law and regulations or through new legislation that clarifies the agency’s existing authority. The new pathway could be funded by user fees, they say.

“Patients need new and affordable treatment options for diseases that have a devastating societal impact,” the post concludes, “and repurposing generic drugs can help address this need…. Our proposed labeling-only 505(b)(2) NDA would eliminate undue administrative burden, enabling non-manufacturers to pursue FDA approval of new indications. It would allow FDA to provide the public with the most up-to-date drug labeling, improving the ability of patients and physicians to make informed treatment decisions.”

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