Why there is no herbal medicine approved by FDA?
Almost all drugs approved by the FDA undergo a rigorous process that involves extensive clinical trials to demonstrate their safety and efficacy for specific medical conditions. These drugs are typically developed and manufactured by pharmaceutical companies, which invest significant resources in research, development, and testing which costs between multiple million dollars or even billing dollars. As a result, pharmaceutical companies often seek patent protection for their innovative drugs to recoup their investment and gain market exclusivity. Patents grant pharmaceutical companies the exclusive right to manufacture and market a particular drug for a specified period, typically 20 years from the date of filing. During this time, no other company can produce the same drug, allowing the patent holder to charge higher prices and recoup their investment.
However, herbal medicines, derived from natural sources such as plants, minerals, and animal products, cannot be patented in the same manner as synthetic drugs. This is because herbal remedies often rely on traditional knowledge or naturally occurring compounds that cannot be exclusively owned by any single entity. Additionally, the composition of herbal medicines can vary due to factors like growing conditions, harvesting methods, and preparation techniques, making it challenging to establish a unique and reproducible formulation that meets the requirements for patent protection. Moreover, most herbal products are priced affordably, which may not yield substantial profits if research and development costs similar to pharmaceutical products are incurred. Consequently, there is less motivation to engage in the same regulatory process specified by the FDA.
While FDA approval is an important indicator of a medication’s safety and efficacy, it does not always guarantee effectiveness, as individual responses to drugs can vary widely. For example, consider antidepressant medications like selective serotonin reuptake inhibitors (SSRIs), which are commonly prescribed to treat depression and anxiety disorders. While many SSRIs have received FDA approval and are widely used, studies have shown that their effectiveness can vary among patients. Some individuals may experience significant improvement in symptoms, while others may not respond as well or may experience adverse effects that outweigh the benefits.
Similarly, FDA-approved pain relievers like opioids have been at the center of a public health crisis due to their potential for addiction and abuse. Despite FDA approval, these medications have been associated with significant risks, including overdose and death. For instance, the opioid medication OxyContin received FDA approval for the treatment of chronic pain, but its widespread use contributed to a surge in opioid-related overdoses and fatalities.
Furthermore, FDA-approved cancer medications, while often effective at targeting specific types of cancer cells, may not always result in long-term remission or improved survival rates. For example, some targeted therapies and immunotherapies have shown promising results in clinical trials but may only provide temporary responses in certain patients, with tumors eventually developing resistance to treatment.
