President Trump's controversial budget plan for the next fiscal year threatens to throw a monkey wrench into the tentative agreement reached by the Food and Drug Administration (FDA), industry, and drug companies to ratchet up competition for expensive drugs. Nearly finalized agreements over the next generation of the Generic Drug User Fee Act (GDUFA) and the Biosimilar User Fee Act (BsUFA) are meant to encourage generics and biosimilars marketers to generate new products that would provide inexpensive competition for brand-name drugs and bring down the prices of sole-source generics. But Trump wants to greatly increase the generic and biosimilar user fees drug manufacturers have already agreed to pay in carefully crafted agreements developed over the past few years. According to the Alliance for a Stronger FDA, Trump's budget outline anticipates a doubling of FDA user fees to $2 billion. Although that general outline doesn't fill in numbers for any Department of Health and Human Services (HHS) agency (that will happen in May), a group that includes the FDA, the HHS itself would see its budget cut by 16.2%: "In the context of the President proposing $54 billion in nondefense program cuts, we can think of no other purpose for an extremely large and totally unplanned increase in user fees than to derive a roughly similar amount in savings from budget authority ... $900 million would represent a third of the agency's BA appropriation," the Alliance for a Stronger FDA says.
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