FDA's user fee program up for reauthorization amid concerns about industry influence

Lawmakers will debate the FDA's $3 billion budget and the pharmaceutical industry's influence on agency funding Sept. 30, according to The New York Times

Last year, three-fourths of the FDA's drug division budget, more than $1 billion, was from its user fee program, in which pharmaceutical companies and devicemakers pay fees to the agency as part of the review process. Critics of the program say it gives the drug and medical device industry too much influence over a process meant to ensure those products are safe and effective. 

"It's kind of like a devil's bargain that I think is not in the best interest of the agency," Joseph Ross, MD, a New Haven, Conn.-based Yale School of Medicine professor who studied FDA policies, told the Times. "It turns this every-five-year cycle into the FDA essentially asking industry, 'What can we do to secure this money?'"

The government has to reauthorize the FDA's user fee programs every five years, and it is set to expire this year. Those who support reauthorization argue the user fees have sped up the process of getting life-saving drugs to the market. 

"It's not an understatement to say that there are many people with us today who would not be here without the program, which has dramatically reshaped drug development and approval in the United States," Peter Marks, MD, PhD, the director of the FDA's vaccine and gene therapy division, told a Senate panel in April. 

Read the full report here.

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars