The FDA recently announced that it is seeking a budget of $7.2 Billion for 2024, part of which is intended for “Advancing Medical Product Availability.”  The portion of the requested budget directed to advancing access to safe and effective medical products would be used toward various initiatives, three of which are highlighted in the FDA’s announcement.

First, the requested budget includes $23 million in additional funds to advance the goal of ending the opioid crisis.  According to the announcement, funding related to ending the opioid crisis will be used to focus on “advancing the development, evaluation and market authorizations of related digital health medical devices.”

Second, the requested budget includes $11.6 million of additional funding for improving the FDA’s medical device supply chain and shortage programs.  The announcement states this supply chain-related funding “will allow the FDA to expand efforts to work proactively with medical device companies, health care providers, device distributors, and patients to enhance resiliency in the supply chain of critical medical devices and prevent shortages of critical devices that most often impact vulnerable populations.”

Third, the requested budget includes $2.5 million to implement the ACT for ALS Act.  The announcement states this funding will help the FDA “to foster development of treatments for ALS and other rare neurodegenerative diseases” in various ways, including by improving access to investigational therapies and medical devices.

Regarding the requested budget, FDA Commissioner Robert M. Califf, M.D. stated:

This year’s funding request builds on our accomplishments and lessons learned over the past year and adds new funding to continue modernizing the FDA and its capabilities for the future. We continue to deliver on a wide range of priorities and have strategically focused our request to ensure our program areas have the funding they need to operate with the highest success for the good of public health.

According to the announcement, the budget request also includes legislative proposals to support the agency’s authority, such as by requiring medical device manufacturers to report manufacturing interruptions or discontinuations regardless of whether such issues are related to a public health emergency.