U.S. House of Representatives Sends $3.2 Billion FDA Budget to the Senate

 

The U.S. House of Representatives approved a $3.2 billion budget proposal for the U.S. Food and Drug Administration (FDA) that will boost the agency’s abilities to approve new medicines and medical devices, as well as protect the nation’s food supplies.

First reported by Regulatory Focus, the publication of the Regulatory Affairs Professional Society (RAPS), the budget, initially approved earlier this month, will include a “minibus” for fiscal year 2021 that provides accompanying language for the FDA guidelines.

According to the report, the “minibus” bills include language that has been designed to support cross-departmental initiatives that will enhance product safety for new drugs, medical devices and food safety. Also, the bill looks to fund new initiatives advancing influenza vaccinations. The funds will also enhance the agency’s ability to respond to outbreaks of foodborne illnesses and also increase the safety and cybersecurity of medical devices. Additionally, the House funding provides financing for the FDA to develop a framework for regulating CBD products. The bill also appropriates $70 million to accelerate medical product development as authorized in the 21st Century Cures Act, according to a brief bill summary posted by the House of Representatives.

Among the financial portions of the bills, the House provided the regulatory agency with mandatory recall authority for prescription and over-the-counter drugs, according to the RAPS report.

Also, the bill includes language that would allow the FDA to “develop a plan to identify, detain, and refuse the import of FDA-regulated products from a foreign establishment that did not allow physical access to FDA investigators.” That language followed a recent Executive Order issued by President Donald Trump that would pave the way for the government to import drugs available to other countries at a lower price than in the United States.

Overall, the priorities and budget for FDA in the minibus are unchanged from the bill approved by the House Appropriations Committee on 9 July, RAPS noted. The $3.2 billion funding recommendation is an increase of $40.8 million above its current funding levels. Total funding for the FDA, including revenue from user fees, is $5.99 billion.

The House spending plan will now move to the U.S. Senate, but it is unknown when that legislating body will begin to examine the proposal. The next fiscal year begins Oct. 20. If the Senate does not approve the spending plan proposed by the House, Congress will need to approve a Continuing Resolution to maintain existing funding levels.