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.
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