March 16, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – Although President Donald Trump has called for streamlining the U.S. Food and Drug Administration (FDA) to make it easier for the approval of new drugs, his first budget proposal indicates plans to make it more of an expensive process for drug companies.
Under the proposed budget, drug and medical device makers would be required to pay more than double the fees for regulatory approval than they do now. The administration has budgeted more than $2 billion in fees to be collected by the FDA this year. The budget document said industries that use FDA approval to market their products “can and should pay for their share,” Reuters reported. The FDA has been charging to review products since 1992. It was estimated that the FDA would take in approximately $866 million in fees for prescription drugs and $324 million for generic drug reviews.
While the fees would go up under the proposal, the plan offers measures to help speed up the approval process for new drugs and medical devices, Reuters said. However, the budget document does not provide any specifics on how the FDA will speed up the process.
Scott Gottlieb, Trump’s FDA commissioner-nominee, is also a proponent of speeding up the approval process. If confirmed by the U.S. Senate, Gottlieb is expected to encourage increased flexibility in clinical trial development. He has also talked about overhauling rules for approval of generic drugs as well as “injecting competition” into the market concerning situations where older drugs are controlled by one manufacturer and allowed to set the price at high levels.
Trump has criticized the FDA, particularly what he called a “slow and burdensome” process of drug approval in the United States. According to Trump’s 100 Day Plan, there are “over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications.” Trump has also called for easing restrictions for drugs that have been approved by foreign regulatory agencies to be available in the United States, which would bypass the FDA’s regulatory authority over drugs available in the U.S.
While Trump is calling for proposed fee increases at the FDA, his spending proposal has taken an ax to the National Institutes of Health and the Department of Health and Human Services. Under the proposal, the Department of Health and Human Services will see a $12.6 billion cut, about 16.2 percent of its budget, the Associated Press reported Wednesday night. Additionally, the National Institutes of Health will see a loss of $5.8 billion, which would cut down on its ability to fund medical research.
