As Congress engages in partisan conflict over how best to trim the federal budget, the U.S. Food and Drug Administration (FDA) is in danger of losing the funding necessary to safely and expediently overhaul its medical device approval process.
According to an article that appeared on September 10, 2012, on the news website Bloomberg.com, the $6.4 billion dollar Medical Device User Fee and Modernization Act (MDUFMA) is in danger of losing funding as lawmakers contemplate $1.2 trillion in federal budget cuts through 2021.
Federal ‘Trigger Money’ Needed for the FDA to Utilize Fees from Device Manufacturers
Although MDUFMA is designed to allow the FDA to substantially increase the amount of fees it receives from private medical device manufacturers to test products such as vaginal mesh devices, it cannot utilize these funds without what is known as “trigger money” provided to the agency by the federal government, an FDA spokesperson told Bloomberg. With these significant budget cuts looming, a loss of funding “could result in the loss of whole user fee programs, programs that have become essential to public health and medical product innovation,” the spokesperson wrote to Bloomberg in an e-mail.
If Congress fails to act, a series of automatic budget cuts will go into effect throughout the federal government, resulting in massive losses of funding. Economists say that so-called “sequestration” is akin to a “fiscal cliff” that could derail economic recovery and push the United States back into recession.
“Even without sequestration, [the] FDA’s workload and statutory responsibilities have grown far faster than its budget,” the spokesperson said.
In March, President Obama signed into law the latest version of the Medical Device User Fee & Modernization Act, more than doubling the fees medical device manufacturers have to pay the FDA to review and test products, from $295 million to an estimated $609 million over five years. That amounts to about 35 percent of the entire budget for the FDA’s Center for Devices & Radiological Health, according to Bloomberg.
The Rottenstein Law Group is hopeful that the FDA will not lose the funding necessary to keep this important program in place.
Injured by Vaginal Mesh? The Rottenstein Law Group Can Help
If you or someone you know has had surgery for pelvic organ prolapse stress urinary incontinence, or another type of pelvic surgery that involved the implantation of vaginal mesh and is experiencing symptoms consistent with malfunction, seek medical attention immediately. The next step is to contact an experienced attorney to see whether you or the person you know has grounds to file a lawsuit against the manufacturer for compensation.
The attorneys at the Rottenstein Law Group have over 25 years of collective experience advocating for victims of dangerous drugs and defective medical devices, as well as other product liability claims. RLG is offering free, confidential legal consultations, and all you need to do is fill out this contact form or call 1-888-419-9511, and one of our attorneys will call you as soon as possible.
For more information download RLG’s free transvaginal mesh brochure.