The Truth Behind the FDA: Regulatory Capture and Pharmaceutical Interests

The United States Food and Drug Administration (FDA) is often thought of as a regulatory body that safeguards public health by ensuring the safety and efficacy of drugs and food products. However, the reality is more complex and often troubling. This article delves into the issues surrounding the FDA's relationship with the pharmaceutical industry, revealing how regulatory capture undermines public health protections and serves corporate interests instead.

Regulatory Capture and the FDA

The term regulatory capture refers to the phenomenon where regulatory bodies become effectively controlled by the industries they are meant to regulate. In the case of the FDA, this issue is pervasive, resulting in a systemic bias that prioritizes pharmaceutical companies' interests over public health concerns.

The FDA's operations are deeply intertwined with the pharmaceutical industry. Not only is the agency staffed and funded extensively by industry, but it also places the companies themselves in the role of self-regulating their operations. This arrangement creates a conflict of interest, where the entities responsible for oversight are also the primary subjects being overseen.

Evidence of Regulatory Capture in Action

To illustrate the detrimental effects of regulatory capture, a recent instance involving the drug droperidol can be cited. Droperidol was a widely used generic antiemetic for over three decades, effectively preventing nausea in surgical patients. Its affordability was a significant factor in its continued use.

Without warning and with little credible evidence, the FDA imposed a ‘Black Box Warning’ on droperidol for its primary antiemetic use, alleging it caused dangerous cardiac arrhythmias. This action effectively ceased its use, despite peer-reviewed research suggesting that the substitute drugs were more expensive and actually caused the arrhythmias that droperidol was accused of.

The Structure of Control and Corruption

The current regulatory system can be likened to an interconnected protective mechanism designed to shield the pharmaceutical industry from competition and ensure high profitability. Much like the FBI being partly funded by the mafia, the FDA is funded to a significant extent by the industries it regulates.

Moreover, the agency's regulations are often loosely enforced, with the industry conducting its own research and self-reporting compliance. Bureaucrats within the FDA are frequently connected to the industry, further entrenching the cycle of regulatory capture. This system allows for a license to cheat, steal, and even kill, as long as the ultimate goal is profit.

Consequences of Regulatory Capture

The consequences of regulatory capture are dire. High drug prices, reduced access to affordable generic versions, and a lack of transparency in drug development and safety assessment are just a few of the detrimental outcomes. The American public is left with an underregulated system that prioritizes corporate profits over public health.

It is crucial to recognize and address the issues of regulatory capture, not only to protect public health but also to restore public trust in the regulatory process. Effective reforms and greater transparency are necessary to ensure the FDA truly serves its intended purpose of protecting consumers and promoting public health.