The pharmaceutical sector plays a critical role in the healthcare system by developing and selling medications to treat various diseases and disorders. Thus, corruption may affect this sector just as much as any other. The pharmaceutical sector’s corruption problem might severely impact quality care and population health. The FDA’s viewpoint on corruption is complex and may not always be in patients’ or doctors’ best interests. Understanding their concerns and beliefs in this area is crucial to persuade the FDA to take a more active role in combating corruption in the pharmaceutical business. This essay uses the stasis theory to examine the FDA’s stance on fraud as a crucial stakeholder in the business. The FDA’s role and position on corruption in the pharmaceutical industry has become stagnant, and it should take a more proactive role in preventing misconduct within the sector.
Background on the FDA and Corruption in the Pharmaceutical Industry
To safeguard public health, FDA oversees the production, distribution, and control of medical devices, food, pharmaceuticals, and other healthcare items. The organization can enforce regulations on the safety and efficacy of these items and works under the Health and Human Services docket (U.S. Food and Drug Administration). Even though it plays a crucial role, the FDA has been accused of not doing enough to combat corruption in the sector.
Several corruption-related cases have affected FDA, and it has not dealt with them appropriately. Bribery, vested interests, and fake clinical studies are corruption problems plaguing the pharmaceutical business for years (White). Patient safety, public faith in the health service, and healthcare expenses are all negatively impacted by corruption. With so much money to be made in the pharmaceutical sector, some worry that profits will take precedence over human safety. The FDA believes that sector self-regulation is enough and that the agency’s time and energy are better spent assessing the safety and effectiveness of medications. However, this wrong perception helps intensify corruption within the sector.
FDA’s Stasis on Corruption in the Pharmaceutical Industry
Using the rhetorical strategy of stasis theory may better comprehend the FDA’s stance on corruption in the pharmaceutical business. Examining FDA’s stasis may infer their priorities, beliefs, and worldview, allowing them to craft an argument that more actively involves their problems. The FDA may be resistive or indifferent to some arguments regarding corruption. However, the stasis theory may help identify these areas and provide ways for persuading them to become more engaged in combating corruption in the sector. The FDA has made it clear that it is more interested in assessing the safety and effectiveness of pharmaceuticals than in regulating the business (Light et al. 593). The agency has said it would pursue enforcement action against corrupt firms using existing laws, including the False Claims Act and the Anti-Kickback Statute. The FDA should be more aggressive in avoiding corruption in the sector, and the current restrictions aren’t adequate.
The FDA’s strong ties with the pharmaceutical sector are another contributing cause to the agency’s stasis. The FDA cannot fulfill its mission because it depends on money from the pharmaceutical and food industries (White). It has raised questions about the FDA’s impartiality when examining pharmaceuticals and medical devices because of potential conflicts of interest. The FDA has been criticized for not being independent enough from the industries it supervises and for failing to disclose its connections with the industry. Calls for more monitoring and openness have resulted from the FDA’s inability to effectively combat corruption in the pharmaceutical business due to a lack of personnel and a dependence on sector self-regulation.
Proposal to Persuade the FDA
Several recommendations can be made to FDA to help combat corruption in the sector. Stressing the potential damage that corruption may do to patients and the health system is crucial for persuading the FDA to become more proactive in avoiding corruption in the pharmaceutical sector (Akomea-Frimpong and Andoh 339). The argument may be phrased to speak to the FDA’s concerns and values by drawing on stasis theory. The agency’s principal aim is to safeguard public health. Therefore, highlighting corruption’s adverse impact on human safety, such as the dangers connected with fake clinical studies or the possibility of hazardous pharmaceuticals reaching the market, may help combat the problem.
A further appeal to the FDA’s feeling of responsibility to safeguard the public interest might be made by stressing the significance of avoiding corruption. The public and the government should advocate for transparency and accountability in FDA’s activities (Lexchin et al. 4). The implications of corruption in the pharmaceutical sector include higher healthcare expenditures and lower public confidence in the healthcare system. The prowould better serve its objective by becoming more involved in combating corruption in the health system. It is possible to convince the FDA to act against corruption in the pharmaceutical sector if the case is framed in a manner that considers the agency’s interests and principles.
Addressing the incompetency of self-regulation is crucial for persuading the FDA to play a more aggressive role in avoiding misconduct in the pharmaceutical business. It should be more transparent, accountable and involve the public in their corruption decisions (Lexchin et al. 6). The approach might appeal to the FDA’s value of evidence-based decision-making by presenting proof of the inability of self-regulation, such as the numerous examples of corruption in the sector. The FDA should communicate with its citizens and the relevant stakeholders in the areas where there is corruption to increase public trust. Preventing corruption by preemptive measures is an important message that may reverberate across the agency.
Previous arguments made to the FDA regarding corruption in the pharmaceutical industry have included emphasizing the need for more stringent regulations and the negative impact of corruption on patients and the industry’s reputation. However, these arguments have been ineffective in persuading the FDA as it is funded by some companies it regulates (White). In avoiding these ineffective arguments, the proposed strategy emphasizes the importance of preventing corruption and highlights the failure of self-regulation. The evidence selected to support this argument includes examples of successful regulatory efforts in other countries and data on the negative impact of corruption on healthcare costs and public trust in the healthcare system. The FDA will be persuaded by this evidence thanks to the use of simple language and visual aids.
Conclusion
In conclusion, knowing the FDA’s current system, values, and problems is crucial for convincing the agency to play a more proactive role in avoiding bribery in the pharmaceutical business. A compelling case can be made by using stasis theory as a framework and customizing the strategy to appeal to the FDA’s mandate to safeguard the public’s health. The significance of preventing corruption, the inadequacy of self-regulation, and the necessity of setting the standard for regulatory excellence must be stressed. Corruption may adversely affect society, including higher healthcare expenditures and less public confidence in the system, which are detrimental to patients and the healthcare industry. Ultimately, encouraging the FDA to address fraud in the pharmaceutical business is crucial to improving healthcare for the public. The FDA can help guarantee that people continue to have faith in the healthcare system and that they will get safe and effective treatments by adopting efforts to reduce the likelihood of corruption.
Works Cited
Akomea-Frimpong, Isaac, and Charles Andoh. “Understanding and Controlling Financial Fraud in the Drug Industry.” Journal of Financial Crime, vol. 27, no. 2, 2020, pp. 337–354, Web.
Lexchin, Joel, et al. “Combating Corruption in the Pharmaceutical Arena.” Indian Journal of Medical Ethics, 2018, pp. 1–6, Web.
Light, Donald W., et al. “Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs.” The Journal of Law, Medicine & Ethics, vol. 41, no. 3, 2013, pp. 590–600, Web.
U.S. Food and Drug Administration. FDA Efforts to Ensure Product Safety, 2022, Web.
White, C. Michael. “Why Is the FDA Funded in Part by the Companies It Regulates?” The Conversation, 2021, Web.