47% of FDA Funding come from Big Pharma
Last updated
Last updated
The Food and Drug Administration's (FDA) user fees from the pharmaceutical industry have increased by over 47% since 2017, while congressionally appropriated funding has increased by almost 21%. In 2022, user fees accounted for about 46% of the FDA's total operating budget, or $2.9 billion.
The FDA's user fees are paid by medical device companies when they submit a premarket submission, register their establishments, or list their devices with the agency. The fees are negotiated behind closed doors and apply to brand-name, generic, and over-the-counter drugs, animal drugs, biologics, and medical devices.
The FDA's reliance on user fees, which have grown significantly in recent years, raises both practical and ethical questions. While user fees—paid by pharmaceutical and medical device companies—accounted for about 46% of the FDA's total operating budget in 2022, some argue that these fees expedite the approval process for drugs and medical devices. The accelerated approval program, funded in part by these fees, has been praised for allowing potentially life-saving drugs to reach patients more quickly.
However, the structure and negotiation of these fees, conducted behind closed doors, are controversial. Critics worry that this financial dependency could compromise the FDA's regulatory integrity, leading to potential conflicts of interest or undue influence by the pharmaceutical industry. The balance between ensuring timely access to medical treatments and maintaining stringent, unbiased safety evaluations remains a significant point of debate.
This financial dependency compromises the FDA's regulatory integrity, leading to potential conflicts of interest or undue influence by the pharmaceutical industry.
In July 2010, a panel of medical researchers and a patient advocate convened to evaluate AstraZeneca's heart drug, Brilinta. The panel voted 7-1 for approval, and the FDA later endorsed the drug, which became a billion-dollar success. However, an investigation by Science revealed that some panel members received significant payments from AstraZeneca and its competitors after the drug’s approval. These "pay-later" conflicts of interest went largely unnoticed and unregulated, highlighting potential biases in FDA advisory processes. Such post-approval financial ties raise ethical concerns about the impartiality of these decisions and the public’s trust in regulatory processes.
Kessler suggests that greater FDA transparency also could help. "Maybe we need to think about whether the process for reviewing conflicts of interest should be done in a more open, independent manner than the current black box the agency uses," he says. But the former agency head warns that FDA still must find and retain the relatively few specialists "who really can contribute to the issues at hand with exquisite, detailed experience." When so many of them take pharma money, Kessler adds, the agency has to be flexible.
This type of corruption is routine in the regulatory captured government health agencies. All of these types of deals must be ended. Justice must be served, its time to end private companies funding their own regulators and time to put corrupt health officials in jail.
