Politics, Regulatory

With the FDA running out of funds, healthcare groups warn that the drug approval process will soon be derailed

The longest ever US government shutdown has forced the FDA to furlough workers and hunker down around key tasks. But with cash running out and their hands tied on gathering new fees, the agency is on the verge of seeing its work on new drug approvals begin to grind to a halt. And a host of prominent healthcare groups — including some well known scientific organizations — are warning that the shutdown now threatens the nation’s access to crucial new therapies.

In a letter to President Trump, Speaker Nancy Pelosi and other lawmakers on Tuesday, 46 advocacy organizations and professional societies called for an end to the shutdown and asked that the FDA return to full capacity because the health of Americans is at stake.

“(W)e 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,” they wrote. “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…”

“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 group includes ASCO and the National Organization for Rare Diseases, which play a role in focusing attention on important new scientific developments in their respective fields.

Experts suggest the FDA has roughly 2 to 3 months of funding on the device side. The drug side is less flush, with about a month of funding left. Submissions made prior to the shutdown on December 22 will be dealt with as usual, while submissions made after that date are placed in queue and will likely not be worked on until the shutdown is resolved, according to Jefferies analysts, who added that if the shutdown continues beyond a month from now, the FDA will only be able to focus on essential matters such as food/product/manufacturing safety and priority review.

Over the past few years, the FDA has grown increasingly popular with biopharma companies, which have enjoyed the most responsive agency they’ve ever known. The focus under Scott Gottlieb has been on accelerated approvals and rapid response to hurry along new drugs from established companies. And all of that is being jeopardized by the shutdown after a period of climbing productivity and record drug approvals.

If the shutdown continues for the foreseeable future, “the agency will have some algorithm of how they go through the queue with drugs/agents with priority review and/or other high need taking priority…our estimate is a PDUFA could get delayed by perhaps the length of time from when funds dry up (next month) to when the government is back open,” Jefferies analysts said.

A separate letter from more than 280 organizations representing health, the environment, doctors and patients also urged President Trump last week to reopen the government.

“Several agencies’ ability to provide critical services, ranging from food and environmental risk inspections to health services, have already been drastically reduced or are threatened if the shutdown continues. We fear a prolonged shutdown will cause needless suffering and have long-lasting health consequences,” they wrote.


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