FDA Policy/General

FDA Budget Request Seeks $477 mil. Funding Boost

David McFarland

— 1 min read
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FDA stands to get an 8% ($477 million) boost under the Biden Administration’s $6.5 billion fiscal year 2022 budget request for the agency. “The request includes $3.6 billion in budget authority — including $343 million in increases — and $2.9 billion in user fees – an increase of $155 million, an FDA release says.” The increased funding will go toward critical public health infrastructure (data modernization efforts), core food safety and medical product safety programs (inspection and surveillance work), it says.

Medical product safety investments under the budget request include “providing dedicated programmatic funding to strengthen and monitor the supply chain; increasing drug safety surveillance and oversight; and improving animal drug safety and predictive technologies.” FDA says an additional $61 million above last year’s total will go toward increasing safe and secure inspections, promoting health equity and addressing the opioid crisis by supporting development of new therapies and smarter enforcement.

 

The agency’s budget proposal also includes legislative proposals to increase FDA's authorities to protect and promote public health, such as:

  • Expanding FDA's authorities over device shortages to help the domestic supply chain and help reduce dependence on foreign production;
  • Expanding its authority to explicitly request records or other information in advance of or in lieu of inspections when travel to or inspection of an establishment is inadvisable;
  • Clarifying its authorities to assess human and animal pharmaceutical critical infrastructure as well as manufacturing quality and capacity, particularly around product discontinuances and manufacturing interruptions;
  • Expanding its authorities in dealing with potential product shortages to require that a drug sponsor submit studies to label a product with the longest possible expiration date that the agency agrees is scientifically justified; and
  • Extending current provisions related to counterfeit drugs to include medical devices and facilitate enforcement actions against such products make it into interstate commerce.

 

The Alliance for a Stronger FDA had this to say: “Because of the multiple funding sources and the mix of one-time and base funding, the FDA budget request is always difficult to interpret. Based on the tables available to us, we believe that the Administration’s request for budget authority (taxpayer) funding for FDA is $3.559 billion. This is a $344 million increase over the FY 21 adjusted base of $3.215 billion... If that is confirmed by further analysis, the Alliance for a Stronger FDA will be pleased and supportive of the Administration’s request for FDA.”

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