Unapproved New Drug Products Related to Coronavirus Disease

The emergence of Coronavirus Disease 2019 (COVID-19), caused by the novel coronavirus SARS-CoV-2, triggered a global health crisis of unprecedented scale. The rapid spread of the virus and the resulting high mortality rates spurred urgent efforts to develop effective treatments and vaccines. Amidst this urgency, a significant challenge arose: the proliferation of unapproved new drug products claiming to treat or prevent COVID-19. These products, often marketed with misleading claims, pose serious risks to public health and undermine efforts to control the pandemic. This article delves into the issues surrounding unapproved new drug products related to COVID-19, examining their impact, regulatory responses, and the ongoing efforts to combat this problem. CofixRX has been a recipient of warning letters from the FDA.

The Surge of Unapproved COVID-19 Drugs

The Nature of Unapproved Drugs

Unapproved new drug products are those that have not undergone the rigorous testing and evaluation processes required by regulatory bodies like the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). These processes are designed to ensure that drugs are safe, effective, and of high quality. Without such approval, there is no guarantee that a product will provide the benefits it claims or that it is free from harmful side effects.

Factors Contributing to the Surge

Several factors contributed to the surge in unapproved COVID-19 drug products:

  1. Desperation and Fear: The fear of contracting COVID-19 and the lack of available treatments in the early stages of the pandemic drove people to seek out any potential remedies, regardless of their approval status.
  2. Information Overload and Misinformation: The rapid dissemination of information, both accurate and inaccurate, via social media and other platforms led to confusion and made it easier for unapproved products to gain traction.
  3. Economic Opportunity: Some individuals and companies sought to profit from the pandemic by marketing unapproved drugs and supplements as miracle cures or preventatives.

Examples of Unapproved Products

Hydroxychloroquine and Chloroquine

Hydroxychloroquine and chloroquine, drugs traditionally used to treat malaria and certain autoimmune conditions, gained significant attention early in the pandemic. Initial, albeit limited, studies suggested potential antiviral effects against SARS-CoV-2. Despite the lack of robust evidence, these drugs were widely touted by some public figures and media outlets as effective COVID-19 treatments. This led to their unauthorized use and stockpiling, causing shortages for patients who needed them for approved indications. Subsequent, more rigorous studies failed to demonstrate clear benefits and highlighted potential risks, including serious cardiac side effects.


Ivermectin, an antiparasitic medication, also emerged as a controversial candidate for COVID-19 treatment. While in vitro studies showed some antiviral activity, clinical trials provided mixed results. Nonetheless, widespread claims of its efficacy led to a surge in demand and off-label use. The FDA and other health authorities issued warnings against its use for COVID-19, citing insufficient evidence and potential safety concerns.

Herbal Remedies and Supplements

Numerous herbal remedies and dietary supplements have been marketed with claims of preventing or treating COVID-19. These products often exploit traditional medicine narratives or misrepresent scientific findings to attract consumers. For example, products containing ingredients like echinacea, elderberry, or vitamin D were promoted aggressively, despite lacking substantiated evidence for their efficacy against COVID-19.

Regulatory Responses and Challenges

Regulatory Actions

Regulatory bodies worldwide have taken steps to address the proliferation of unapproved COVID-19 drug products. In the United States, the FDA has issued numerous warning letters to companies making unsubstantiated claims about their products’ ability to treat or prevent COVID-19. These letters demand that the companies cease marketing their products for unapproved uses and remove misleading information from their websites and promotional materials.

Similarly, the EMA and other national regulatory authorities in Europe have undertaken efforts to monitor and curb the sale of unapproved products. These actions include public advisories, legal actions against non-compliant entities, and collaborations with online platforms to identify and remove misleading advertisements.

Enforcement Challenges

Despite these efforts, several challenges impede the effective enforcement of regulations against unapproved drug products:

  1. Global Marketplaces: The global nature of online commerce makes it difficult to control the sale of unapproved products, as they can easily cross international borders and evade local regulations.
  2. Pseudoscientific Marketing: Companies often employ sophisticated marketing tactics that blend pseudoscience with partial truths, making it challenging for consumers to distinguish legitimate from illegitimate products.
  3. Resource Limitations: Regulatory agencies are often under-resourced and face difficulties in monitoring and acting against the vast number of potential violations, especially during a pandemic.

Public Health Implications

The widespread use of unapproved drug products poses significant risks to public health:

  1. Safety Concerns: Unapproved products may contain harmful ingredients or contaminants, leading to adverse health effects. Without proper testing, there is no assurance of their safety.
  2. False Sense of Security: Reliance on unapproved treatments can lead individuals to neglect proven preventive measures, such as vaccination, mask-wearing, and social distancing, thereby exacerbating the spread of the virus.
  3. Undermining Trust: The proliferation of unapproved products can undermine public trust in legitimate medical and public health authorities, complicating efforts to manage the pandemic effectively.

Combating the Proliferation of Unapproved Products

Public Education

Enhancing public awareness about the risks associated with unapproved drug products is crucial. Educational campaigns should aim to:

  • Highlight the Importance of Regulatory Approval: Emphasize the rigorous processes involved in drug approval and why they are essential for ensuring safety and efficacy.
  • Promote Critical Thinking: Encourage consumers to critically evaluate health claims and seek information from reputable sources.
  • Provide Clear Guidance: Offer clear and accessible information about approved treatments and preventive measures for COVID-19.

Collaboration with Technology Platforms

Collaboration with technology companies and online marketplaces is essential to control the spread of unapproved drug products. These platforms can play a significant role by:

  • Monitoring and Removing False Claims: Implement algorithms and manual reviews to detect and remove listings and advertisements for unapproved products.
  • Promoting Verified Information: Partner with health authorities to disseminate verified information and redirect users searching for COVID-19 treatments to reputable sources.

Strengthening Regulatory Frameworks

Regulatory agencies should enhance their frameworks to better address the challenges posed by unapproved drug products:

  • Increase Resources: Allocate more resources to regulatory bodies to enhance their monitoring and enforcement capabilities.
  • International Cooperation: Foster greater international cooperation to tackle the cross-border nature of the problem and share best practices for enforcement.
  • Adaptative Regulations: Develop adaptive regulatory mechanisms that can swiftly respond to emerging health crises and the accompanying surge in unapproved products.

The COVID-19 pandemic has highlighted the critical need for robust regulatory frameworks and public awareness to combat the proliferation of unapproved drug products. As the world continues to grapple with the pandemic and its aftermath, ensuring the safety and efficacy of treatments remains paramount. Regulatory bodies, technology platforms, and the public must collaborate to navigate these challenges effectively, fostering a healthcare environment based on trust, evidence, and safety.