Since its starting point, the Food and Drug Administration has played a critical role in protecting public health through drug regulation, but its effectiveness has been an ongoing debate.

In 1906, President Theodore Roosevelt created a system so that consumers are able to rely on the safety of products being provided to them. Though the FDA’s purpose is a strong one, they have had several complications in keeping up with societal changes. 

Many critics argue that the FDA does not pay attention enough to what medications contain or how they affect patients over time, such as the actual ingredients inside a product and abiding symptoms linked with medicines. With all of that being said, is the FDA really effective? 

Numerous events in history demonstrate the historical failures and reforms from the FDA. One of them was the thalidomide disaster in the 1960s, where pregnant women were on a drug that improved morning sickness. However, long-term consequences were not taken into consideration which resulted in several infants being born with birth defects, missing limbs, and other deformities. 

Not only did this incident cause individuals to misplace their trust in the organization, it created a divide between patients’ desperation for treatment and their ability to trust the safety of medical care.

Even though the FDA’s main goal is to keep the public safe and ensure drug safety, the lack of transparency makes this goal hard to achieve. Regardless of Congress consistently pushing for the FDA to share major clinical information, the FDA still waits for people to file Freedom of Information Act requests before releasing critical data, causing significant delays in transparency making people question if the FDA is really doing what is necessary to keep the public informed. 

And if the FDA cannot even tell the public basic information, why should they be allowed to tell citizens what they can or cannot put in their bodies?

Despite this, the FDA has made improvements. For instance, the FDA released the Food and Drug Omnibus Reform Act in 2022, which aided in perfecting the drug approval process. With this act, individuals praised the organization for their swiftness during the pandemic.

It should not take people being in despair, questions yearning for an answer, and ridicule from higher ups in order to strive for a goal that was set in stone from the beginning

However, despite these efforts, serious problems continue to occur. Earlier this year, a botulism outbreak linked to ByHeart baby formula made over 50 infants sick across multiple states. 

Many people criticized the FDA for not requiring safety tests or other systems that might have prevented this, raising more concerns of the operation doing what is necessary for the more vulnerable. Reliability necessitates consistent performance. Without consistency and transparency, those in dire need cannot depend on a product.

In addition, the FDA needs to set stricter procedures in place to completely fulfill its intended purpose, alongside more proactive measures like prompt response times and time management. That way consumers are not in pain anticipating if it is the wisest decision to take a specific medicine or use a particular product.

Expanding on all of these efforts will not only help the company and their credibility but also ensure that consumers are safely putting medications into their bodies that improve their health, not sabotage it.

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