Remember the game show Password? The program’s slogan was “It’s not what you say -- it's what you don't say.”
And so it is with the sequester at the FDA. It’s not what the agency is doing – it’s what they’re not doing.
According to an article in the April edition of Nature Biotechnology:
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.”
It’s the invisible hand of innovation postponed that is the most pernicious aspect of the White Oaks sequester.
The complete Nature Biotechnology article can be found here.
