The Questionable Validity of an FDA Approval

Leeya Azemoun, Grade 10

The Food and Drug Administration, commonly shortened to FDA, requires all medical and food products to be subject to their approval before being released on the market. This is, of course, necessary to ensure the safety of the general public who consume these products. However, there has been copious controversy over whether or not FDA approval is actually trustworthy. This concern first percolated when people who consumed FDA-approved medication faced major life-threatening side effects, which directly invalidates the approval the product received.

One of the most renowned cases of this occurring was in 2003 when Timothy Witzcak was prescribed Zoloft to aid him in falling asleep. When Witzcak ingested Zoloft, an FDA-approved drug, the repercussions were far worse than what the medicine was meant to cure to begin with. He was left with very severe physical and mental ailments, including “diarrhea, night sweats, trembling hands, nightmares and worsening anxiety. Woody [Thomas] became highly agitated and irritable. His insomnia worsened. He described feeling like his head was outside his body,” (1). Witczak hung himself in his garage because of the depression and anxiety Zoloft instigated. His wife, Kim, testified “Woody and I never once questioned the drug. Why would we? Zoloft is FDA-approved, given to him by his doctor, and advertised and sold as safe and effective,” (1).  As any person would, the Witczaks assumed that an FDA-approved product would be safe to consume. However, as many people found, this wasn’t always the case.
 
Thomas Witczak was just one of the many quintessential cases of false FDA approvals. In fact, 53,000 hospitalizations and about 2,400 deaths occur weekly in the US as a result of FDA-approved prescription medication (2). The FDA approval process, when documented by the administration itself, seems like a meticulous one. In their own description of their process, they are keen to note “A team of CDER [Center for Drug Evaluation and Research] physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company’s data and proposed labeling,” (3). The website covers the entire process, from preventing labeling bias or blunders and preliminary animal testing before trial. Although the administration cannot divulge all of the minutiae of the process, the information that was disclosed had a few noticeable flaws when they were further investigated. For instance, the line “The center [CDER] ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks,” (3). Although this seems like another promise of safety from the FDA, the disregard for looking to eradicate all risks and instead solely seeking to “outweigh” the detriments is what leads to most of the drugs that are not sufficiently checked and lead to side effects and deaths like Witczak fell victim to.

Unfortunately, the updated FDA approval standards’ logistics only worsened the issue by affirming that drugs are “safe and effective” with no actual evidence and grant accelerated approval more leniently to “drugs that address an unmet medical need,” (2) which are extremely convoluted and low standards for approval.  The requirements for FDA approval of medications is only getting more vague and lenient. FDA approval is supposed to guarantee safety, but FDA testing does not guarantee anything. Fast-Tracked and Accelerated Approval is also a source of concern. The reformed system also expanded Fast-Tracked Approval pathways and opportunities, since the presidential administration, including FDA commissioner Scott Gottleib, initially criticized the FDA for how long it took to approve drugs and now are subsequently instating more lenient regulations and Fast-Tracking Opportunities (4). A faster approval system would mean that drugs would be even less carefully screened for safety. Impetuously checked medications will inevitably lead to an increasing number of harmful drugs available, making an FDA approval practically meaningless.

An American Medical Association study found that when the FDA tested drugs based on their risk factor or 501(k) process, the low-risk clearance was only 78% (5) and the only criteria that needed to be met was being just low-risk enough or having benefits that just outweigh the possible side effects.  This, of course, makes way for a very large margin of error. This study was published in 2011 and proposed for a reform of the process. As aforementioned, it has since been reformed, only amounting to a system that allows for an even wider margin of error. The administration itself describes drug approval in their own words as “a balancing act,” (1) which is a source of concern for medical consumers who are aware of this and a threat to the health of those who aren’t. The FDA exists to ensure the public’s safety, but at its current state, it is not doing much to that effect. Unless the approval process is properly amended, drug consumers will remain subject to the “balancing act” that is the FDA’s drug approval process.

Citations:
[1]  M. Llamas, Misplaced Trust: Why FDA Approval Doesn’t Guarantee Drug Safety. Drug Watch, (2017).
[2] D. Light, Risky Drugs: Why the FDA Cannot Be Trusted. Harvard University Edmond J. Safra Center for Ethics, (2013).
[3] Development and Approval Process. US Food & Drug Administration, (2019).
[4] C. Brander, FDA Approvals: On a Fast-Track to Disaster. National Women’s Health Network, (2017).
[5] D. Zuckerman, PhD; P. Brown, BS; S. Nissen, MD; Medical Device Recalls and the FDA Approval Process. Archive of Internal Medicine 171, 1-6 (2011).

Image Retrieved From:
[1] https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/227466

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