Biden’s Budget Seeks Bigger Investments And Expanded Authority For FDA

WASHINGTON- The Biden Administration’s 2022 budget, released at the end of last week, seeks significant spending increases for the U.S. Food and Drug Administration. 

The fiscal year 2022 budget request sets out $6.5 billion for the FDA, an increase of almost 8% ($477 million) over last year, which the agency says will modernize public health efforts and help to confront public health issues like the opioid crisis.

It also included a series of legislative proposals to expand the agency’s authority, which the agency has said “complement” the increased investments.

The expenditures follow the trend of Biden’s budget, the first of his presidency, which outlines $6 trillion in federal spending. 

Analysts have commented, since the partial requests were released earlier this year, that the administration is embracing a substantial expansion of the federal government’s spending powers, as part of a larger vision that believes the federal government needs to play an active role in addressing the pressing issues in front of the country. Several articles in Vox, for instance, described the increases in non-defense discretionary funding as a clear break with austerity politics and budget caps, and an embrace of “big government.” 

The FDA has said of the increases, in both authority and investments in the agency, that they will improve the readiness of the American public health system to handle the next public health crisis, as well as making vital “infrastructure investments” for modernization, safety inspection programs, health equity for minorities, and to address the opioid crisis.

Included among the funding laid out in the budget request is $185 million in new infrastructure investments, which the FDA has said will help with data modernization, to update and expand its laboratories, and improve its federal buildings.

The data modernization proposal follows up on the agency’s “Data Modernization Action Plan,” released earlier in the year, which described the agency’s intention to update its systems for the digital world. 

Much of the agency’s data systems, the plan said, are still geared towards “non-digital, document-based” data, creating what the agency described as an urgent need for updating.

An additional $97 million will serve to invest in core food and medical safety programs, the agency said. 

According to the agency, this funding will cover food safety investments, aimed at reducing the number of illnesses caused by FDA-regulated foods, as well as programs designed for maternal and infant nutrition and animal food and drug safety. It also includes investments to strengthen and monitor the drug supply chain, the agency said in a written comment.

Another $61 million in investments was set aside for the agency’s capacity to deal with public health issues facing the U.S. 

It will improve the agency’s ability to tackle the opioid crisis, for instance, by supporting “smarter enforcement” and aiding the development of new therapies, the FDA said.

The request includes provisions to expand the FDA’s authority to keep counterfeit drugs and medical devices out of the U.S. and to require shortage notifications from manufacturers of infant formula, among other things.

The FDA is also asking for authorization to require drug sponsors to establish the “longest possible” expiration date in order to prevent possible drug shortages in the future. It also asks for clarification from Congress about its authority to assess pharmaceutical manufacturing capacity.

As noted above, the Biden administration’s budget had other notable infrastructure increases for federal agencies as well.

For instance, it requested $58.5 billion for the U.S. Department of State and the U.S. Agency for International Development to “support the president’s vision of restoring America’s leadership around the globe.”

USAID has previously praised the administration for reversing the trend of the previous four years in increasing foreign assistance funding.

“Where we choose to invest speaks to what we value as a nation. This year’s budget, the first of my presidency, is a statement of values that define our nation at its best,” President Joe Biden said in a prepared comment to Congress where the bill is expected to face legislative pushback from Republicans.

“We look forward to continuing to work with Congress to ensure the FDA has the resources it needs to carry out our vital mission to protect and promote public health,” Acting FDA Commissioner Janet Woodcock said.