FDA User Fee Programs Set to See Reauthorizations but With Changes

June 15, 2022 by Alexa Hornbeck
FDA User Fee Programs Set to See Reauthorizations but With Changes
FDA Worker Doing Lab Work Courtesy of The U.S. Food and Drug Administration Flickr.

WASHINGTON — The Senate Committee on Health, Education, Labor and Pensions voted on Tuesday to advance legislation that will reauthorize a number of important U.S. Food and Drug Administration user fee programs.

“This is the most important, comprehensive FDA legislation to come out of this committee in many years,” said Sen. Patty Murray, D-Wash., who serves as chairwoman of the Senate HELP Committee, during the hearing. 

FDA user fee legislation ensures that as the FDA gets more new drugs or devices to consider for approval, it also gets more resources to support that work. The committee passed the FDA Safety and Landmark Advancements Act by a vote of 13-9. 

In the bill, the committee has taken action in areas ranging from regulating dietary supplements, cosmetics reform, modernizing accelerated approval pathways and taking steps to make it easier for cheaper, generic and biosimilar drugs to get to market. 

“These changes will help ensure that the FDA prioritizes patients, and will help bring down health care costs which so many families are struggling with,” said Murray. 

The committee also took action in the bill to provide a path for safe prescription drug importation from Canada. 

“This is going to be a big deal… for access to safer drugs at lower prices,” said Murray. 

The bill will also establish a deadline for FDA to issue a final rule on over-the-counter hearing aids, no later than 30 days after the enactment of the FDASLA. 

Wedged into the legislation packet is also the VALID Act, known as the Verifying Accurate, Leading-Edge IVCT Development Act, which would establish a regulatory category called in vitro clinical tests, including current laboratory developed test services, and support the next generation of medical products. 

Also included in the legislation are new steps to hold FDA and manufacturers accountable to address infant formula shortages, such as requiring the FDA to submit a report to Congress on the timelines related to FDA’s review of premarket submissions for infant formula, and publishing a list on the FDA website detailing which infant formula products may be appropriate substitutes for infant formula products in short supply that are relied on by individuals with amino-acid and metabolic conditions.

The House voted 392-28 to pass legislation H.R. 7667 on June 8 to reauthorize FDA user fee programs.

The FDASLA will now head to the Senate floor for a full vote that is expected to occur sometime before the end of September, as current user fee agreements for the FDA are set to end on Oct. 1, 2022. 

Alexa can be reached at [email protected] 

A+
a-
  • FDA
  • fee programs
  • reauthorization
  • In The News

    Health

    Voting

    In The News

    February 27, 2024
    by Tom Ramstack
    Senators Accuse Biden of Exceeding Authority for Military Strikes in Yemen and Red Sea

    WASHINGTON — Republican senators at a hearing Tuesday foretold a conflict with the Biden administration over the president’s authority for... Read More

    WASHINGTON — Republican senators at a hearing Tuesday foretold a conflict with the Biden administration over the president’s authority for recent military action in Yemen and the Red Sea. They expressed concern that the United States is sinking into war through an escalating response to attacks... Read More

    February 27, 2024
    by Dan McCue
    ‘Intense’ Discussion of Ukraine Aid Overshadows Government Shutdown Talks

    WASHINGTON — With Congress at a virtual standstill, President Joe Biden on Tuesday urged Republican and Democratic leaders to act... Read More

    WASHINGTON — With Congress at a virtual standstill, President Joe Biden on Tuesday urged Republican and Democratic leaders to act swiftly to avoid a government shutdown and finally pass long-stalled emergency aid to Ukraine and Israel. Biden invited House Speaker Mike Johnson, R-La., House Minority Leader... Read More

    February 27, 2024
    by Dan McCue
    Builders Making Solar a Standard Feature for New Homes

    WASHINGTON — Four of the nation’s largest home builders have signed contracts with SunPower to pre-install its Equinox® solar systems... Read More

    WASHINGTON — Four of the nation’s largest home builders have signed contracts with SunPower to pre-install its Equinox® solar systems in select communities across the country. The move by the builders — Beazer Homes, CC Homes, Meritage Homes and Toll Brothers — is seen as signaling... Read More

    February 27, 2024
    by Dan McCue
    House Republicans Raise Questions About EV Charger Program

    WASHINGTON — Republicans on the House Energy and Commerce Committee are raising questions about the implementation of the Biden administration’s... Read More

    WASHINGTON — Republicans on the House Energy and Commerce Committee are raising questions about the implementation of the Biden administration’s electric vehicle charger subsidy program. In a letter to Transportation Secretary Pete Buttigieg and Energy Secretary Jennifer Granholm, a trio of Republican lawmakers led by Committee... Read More

    February 27, 2024
    by Dan McCue
    Energy Department to Award $366M to Projects in Tribal, Rural Communities

    WASHINGTON — The U.S. Department of Energy on Tuesday announced it is awarding $366 million to 17 projects intended to... Read More

    WASHINGTON — The U.S. Department of Energy on Tuesday announced it is awarding $366 million to 17 projects intended to bring power and much-needed clean energy upgrades to rural and remote areas across the country. Of the projects, a dozen will be undertaken on tribal lands... Read More

    February 26, 2024
    by Tom Ramstack
    States Try to Convince Supreme Court to Keep Laws Regulating Social Media

    WASHINGTON — The Supreme Court seemed skeptical Monday of two state laws that could redraw social media companies’ right to... Read More

    WASHINGTON — The Supreme Court seemed skeptical Monday of two state laws that could redraw social media companies’ right to decide what sort of content is displayed on their platforms. The tech companies say the Florida and Texas laws that seek to limit which content they... Read More

    News From The Well
    scroll top