Fox News’s Bret Baier recently interviewed Elon Musk and other Department of Government Efficiency (DOGE) executives, outlining their plans for the program while sharing some harrowing realities about our federal government. Tom Krause, a member of DOGE tasked with overhauling the Treasury Department, revealed, “The Federal Government could not pass an audit.” This remark raises questions about accountability within government regulatory agencies. Bureaucracies that provide oversight to corporations expect a high standard of accountability, compliance, and quality, but do they offer a comparable level of excellence and culpability in their practices?
Government regulations continuously pressure corporations and small businesses. Extensive regulations span environmental policies, guidelines for handling sensitive materials, data management protocols, and manufacturing rules, to name a few. The scope and stringency of these requirements vary by industry, with sectors such as pharmaceuticals, commerce, energy, and real estate often facing the most burdensome mandates. In addition, companies remain persistently threatened with unannounced audits and regulatory appraisals.
Pharmaceutical companies must navigate a complex regulatory framework. They adhere to protocols from bench to bedside, such as Good Laboratory Practices (GLP), Good Tissue Practices (GTP), current Good Manufacturing Practices (cGMP), and Good Documentation Practices (GDP), among others. Employees are burdened with superfluous and monotonous training requirements. Minor deviations or documentation errors trigger rigorous investigations that can incur substantial costs and delay product releases. Moreover, any changes to manufacturing specifications require additional FDA approval. Should a drug later exhibit a secondary benefit, it must undergo a separate approval process to avoid legal issues related to “off-label use.” Every procedure — from ensuring sterility and proper cleaning to managing recalls — must be traceable and subject to strict, documented guidelines.
The FDA has unilateral power to approve and disapprove drugs going to market. It can also pause drug development at any stage for any infraction it deems appropriate. Companies must promptly address any observations the FDA makes during an audit; failure to do so will inevitably result in further consequences. The major findings and observations during audits are publicly disclosed, theoretically promoting accountability. But with such power, what forces are at bay to ensure the FDA itself is running effectively?
reliance on legacy IT systems. These outdated systems jeopardize data integrity, leading to potential entry errors and financial management inefficiencies. The FDA’s centralized role in approving drugs paints a stark picture; these antiquated systems may impact patients’ ability to receive medicines. Flow and organization of data are essential for streamlining approval processes. The FDA requires thorough audit trails of data and information from private companies when they conduct investigations and audits; it appears they do not hold the same standard for themselves.
The 2023 case involving Public Citizen illustrates more challenges. Public Citizen petitioned the FDA to issue adequate warnings about the risk of tendon injuries associated with fluoroquinolone antibiotics. The FDA lagged public demand for more information. Again, the faulty systems, slow response times, and inefficiency plagued the FDA’s ability to respond. This petition did not result in court rulings or legal action against the bureaucratic body. The FDA eventually expedited its review of the safety concerns due to pressure, demonstrating the agency’s incapability to address problems urgently. Regulators would not extend the same mercies to a pharmaceutical or food company; they would demand an explanation for the discrepancies and a timely plan to address them.
Scrutiny persists regarding the FDA’s capacity to promptly execute recalls, evaluate food safety, and address public health concerns. Inefficient systems, outdated software, and poor data management have left food items on the shelves that should have been long recalled. The agency’s handling of clinical trial data during COVID-19 vaccine studies further exposed data management and public communication deficiencies. Even their lackluster drug approval process was probed and criticized. Perhaps the FDA should be put on a disciplinary pause. Government regulators would impose marked consequences on a private enterprise if it were responsible for such failures. The company’s mistakes would be publicly displayed; the FDA would demand accountability and halt all manufacturing until issues were resolved. Unfortunately, the same criterion is not applied to the FDA. Federal entities often take little to no action for their mistakes. When action is taken, other regulatory or government bodies impose the disciplinary measures, resulting in institutional self-regulation.
The FDA’s shortcomings are often obscured, and large corporations and pharmaceutical companies become scapegoats in narratives portrayed by the media. Unlike the FDA, these entities face costly lawsuits and regulatory penalties because they are not shielded by sovereign immunity. Yet, the agency with unilateral power over drug approvals and enforcement remains largely unaccountable for its failures. This raises a critical question: Who watches the Watchmen?
While initiatives like DOGE aim to modernize government systems, true reform requires more than technological upgrades. These efforts must include meaningful accountability and independent oversight to ensure that institutions responsible for safeguarding public health adhere to the same standards they impose on private industry. Without such measures, organizations like the FDA may continue to operate in a regulatory vacuum where its authority is unchecked and its deficiencies remain unchallenged.
Matthew Williams is a compliance and technical investigator for pharma and is a freelance writer focusing on healthcare and pharma reform. Follow him on X @Back2TheCenter
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