Shutdown's Impact on the FDA

 
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The ongoing partial government shutdown is now the longest in U.S. history, with no certain end in sight. While the impact of the shutdown is wide and far-reaching, at the Children’s Cause we are focused on the Food and Drug Administration, an agency that has a direct impact on the development of life-saving therapies for our kids.

FDA Commissioner Scott Gottlieb, MD, has stated that the agency will run out of drug approval funds sometime in February if the shutdown continues. About 45% of the FDA’s budget comes from “user fees” - fees paid by industry to review drug applications. But since the shutdown began, no new applications or fees can be accepted, so those funds will run dry in about four weeks.

According to the latest news reports:

  • From CNBC: “[The shutdown] could create big problems for drugmakers, especially those that may be low on cash and scrambling to push new, innovative drugs to the market to stay in business, analysts say. Delays wouldn't just impact companies with pending applications but those waiting to file once the shutdown ends.”

  • From the National Law Review:  “The Prescription Drug User Fee Act, which authorizes FDA to collect fees from companies that produce certain human drug and biological products, is the most vulnerable program, likely to run out of money the first week of February. Manufacturers, researchers, and others involved in the creation of these products should continue to monitor for developments but should expect likely delays in all FDA review activity.”

  •  From the Wall Street Journal: “On or about Feb. 8, the agency will have to stop work on applications for new drugs, the FDA said. According to senior agency officials, the FDA’s 2,000 new-drug and medical-device employees can’t be called in to do unpaid work, and would instead be furloughed. … One FDA official said that advisory committees of outside doctors—essential to the drug approval process—are close to being canceled.”

Yesterday, January 22, the Children’s Cause joined with 45 other public health organizations in sending a letter to the President and Congressional leaders. Our letter asks the President and Congress to take action to immediately bring the FDA back to full capacity, to prevent the snowballing impact of ongoing disruptions to the agency.

Here’s more of what we shared with President Trump, Speaker Pelosi, Majority Leader McConnell, and Minority Leaders McCarthy and Schumer:

“On behalf of patients across this country, we are greatly concerned that the agency is currently not fully funded, and thousands of vital FDA employees are not working or able to operate at full capacity. While we applaud Commissioner Gottlieb, FDA leadership, and “essential staff” for truly heroic work to keep many aspects of its mission functioning, we fear that this continued shutdown not only puts the current health and safety of Americans at risk, but has begun to put future scientific discovery and innovation in jeopardy.

The ongoing government shutdown forces the FDA to make difficult choices regarding to which essential functions its greatly reduced resources are directed. These are decisions that never should have to be made— the health and safety of Americans today should never be weighed against the prospect of new life-saving therapies for patients. Tragically, that is what is happening.”

The FDA’s limited capacity also impacts the recently passed RACE Act (Research to Accelerate Cures and Equity for Children Act) by slowing down the process of evaluating whether cancer drugs being reviewed should also be tested in children with cancer.  

By all reports, the approval backlog created by the shutdown is likely to have long-lasting implications on the agency - beyond the shutdown’s end - so we will be monitoring this situation for the foreseeable future and will keep you posted.

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