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When is it okay to manufacture commercially-available pharmaceuticals?

User Yasuko
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Final answer:

It is okay to manufacture commercially-available pharmaceuticals after they have been rigorously tested and approved by the FDA to ensure they are safe and effective. The regulatory process protects the public from unsafe drugs but also has drawbacks, such as delaying access to new treatments and potentially stifling innovation. Natural compounds play a vital role in developing new medicines, but biodiversity loss threatens this source of pharmaceutical innovation.

Step-by-step explanation:

To ensure safety and efficacy, the Food and Drug Administration (FDA) regulates the medicines that pharmacies are allowed to sell in the United States. The process for a company to test a drug and bring it to market can be lengthy, often requiring several years of rigorous experimentation and trials involving chemists and physicians to verify that a drug is safe and effective for human use.

While many recognize the protected public as the winners of this system for being safeguarded against unsafe drugs, the losers in the situation are less visible. These losers may include patients with rare or terminal illnesses who face delayed access to potentially life-saving treatments due to the slow pace of regulatory approval. Moreover, strict regulations might stifle innovation, as pharmaceutical companies could be deterred from investing in the development of new drugs given the uncertainty and costs associated with the FDA approval process. Additionally, the cost of conducting such extensive research and development is often reflected in the high prices of new pharmaceuticals, which can limit access for those unable to afford them.

The search for new compounds, especially those derived from natural sources, is critical as they represent a significant portion of pharmaceutical advancements. It's estimated that about one-third of pharmaceutical research and development expenditures are spent on natural compounds, and nearly 35 percent of new drugs marketed between 1981 and 2002 originated from these sources. However, the potential for discovering new medications is threatened by the loss of biodiversity, with the disappearance of species potentially reducing the opportunities for pharmaceutical innovation.

User Prithvi Uppalapati
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