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Sequestration to slash research grants and delay biosimilars

Nature Biotechnology volume 31, page 271 (2013)Cite this article

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“BIO is particularly concerned that the sequestration, as implemented, will not only shrink public funding for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), but also, more specifically, will deny FDA the ability to use a portion of the user fees provided to the FDA by private companies under the Prescription Drug User Fee Act (PDUFA),” says Jim Greenwood, president and CEO of the Biotechnology Industry Organization (BIO) in Washington, DC. “We are learning that under sequestration, companies' user fees must still be paid, but FDA will not be allowed to spend all of the funds. This is very concerning to BIO—and more importantly to all patients eagerly awaiting approval of new drugs and therapies to treat their diseases.”

The budget sequester is “not the end of the world, but it's not good for FDA,” says Peter Pitts, president of the Center for Medicine in the Public Interest in New York. For example, PDUFA dates may need recalibrating. US Department of Health and Human Services (HHS) secretary Kathleen Sebelius has warned that FDA cutbacks will heighten food safety risks from fewer inspections, but Pitts points to longer-term strategic effects arising from the sequester. “Anything having to do with policy development, such as dealing with biosimilar drugs, will grind to a halt,” he says. “The sequester will delay regulatory innovation by pushing things that are important but not life-threatening off the agenda.”

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    Jeffrey L Fox

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Fox, J. Sequestration to slash research grants and delay biosimilars. Nat Biotechnol 31, 271 (2013). https://doi.org/10.1038/nbt0413-271

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