Rep. Hill Issues First Golden Fleece of the New Decade
WASHINGTON D.C. — Congressman French Hill (R-AR) named the Food and Drug Administration (FDA) as the first winner of the Golden Fleece Award in 2020 for failing to issue fines and against clinical trial sponsors who did not disclose their trial results within one calendar year. In 2017, the FDA gained the ability to charge violators who did not disclose trial results $10,000 per day. However, a recent study found that only 41 percent of 4,209 clinical trials reported data to the FDA.
“When trial sponsors fail to disclose the results of their research, life-saving information is lost in the process. If a clinical trial fails, knowing how it failed and why it failed is just as important to knowing why it succeeded for other researchers who study public health,” said Congressman Hill. “The FDA must be held accountable and responsible for ensuring that clinical trial sponsors follow the rules so that this information is available to American patients and the medical community.”
In the letter to the Commissioner of Food and Drugs Dr. Stephen Hahn, Congressman Hill wrote:
The Honorable Stephen M. Hahn, MD
Commissioner of Food and Drugs
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Dear Dr. Hahn:
I write today to inform you that the Food and Drug Administration (FDA) is this month’s recipient of my Golden Fleece Award. The Golden Fleece Award, instituted by Sen. William Proxmire, highlights wasteful government spending by our nation’s federal agencies.
A recent study published in The Lancet found that, of the trials conducted during an 18-month period that were required to be reported to clinicaltrials.gov, only 41% reported within the required one-year deadline and more than 35% did not report results at all. Additionally, although the FDA has the authority to fine trial sponsors $10,000 per day that a trial sponsor does not report results after the one-year deadline, the study found no evidence that the FDA has exercised this enforcement mechanism, which could have resulted in over $4 billion in fines as of September 2019.
The findings of this study are concerning principally because of the public health implications of trial sponsors not reporting results. The absence of publicly released trial results can contribute to research waste, non-publication bias, and a distorted evidence base for clinical practice. The failure of the FDA to use the enforcement mechanisms available to it seems to be a failure to fulfill its mission to protect the public health. Additionally, when our nation is over $20 trillion in debt, it is essential that our federal agencies act as good stewards of taxpayers’ dollars.
I urge you to rectify this practice, and should you require any additional authority from Congress to address these concerns, notify us as soon as possible. Thank you for your consideration, and I look forward to working with you to address this important issue.
Member of Congress
To view the letter, click HERE.
About the Golden Fleece Award
Every year, Congress appropriates trillions of dollars to fund the federal government, and every year the federal government wastes portions of these funds in unconscionable ways. In an attempt to increase accountability for every single government program, Congressman Hill decided to bring back the Golden Fleece Award.
Originally introduced by Democratic U.S. Senator from Wisconsin William Proxmire in March 1975, the Golden Fleece Award was a monthly bulletin on the most frivolous and wasteful uses of hardworking taxpayers’ dollars. The Golden Fleece Award became a staple in the U.S. Senate during this time, and Senator Robert Byrd once stated that the awards were “as much a part of the Senate as quorum calls and filibusters.”
In reviving this idea, the Golden Fleece Award will again have the opportunity to serve as an important reminder to taxpayers about the need for necessary, commonsense reforms to our federal spending.