Op-Ed: Oversight or Oversight? 5 Ways the FDA Failed the Public This Year
“This product has been approved by the Food and Drug Administration.” That endorsement should be the gold standard by which consumers make smart choices about the medications they use and products they trust. Unfortunately, each year the FDA lets many severely defective drugs and products slip though.
The FDA’s drug recall rate in 2022 was its highest in five years, and things didn’t get better in 2023. Here are 5 drugs and products that tragically harmed instead of healed this year:
#5 Ozempic/Wegovy: Emily Wright was prescribed Ozempic by her doctor as treatment for her diabetes. She expected some nausea and vomiting – but not for her stomach to become permanently paralyzed. Emily is one of many Ozempic patients dealing with the severe consequences of gastroparesis, even though the drug’s label never warned about the condition as a possible side effect.
Drug labels are reviewed and approved by the FDA.
#4 Gardasil: Drugmakers have to submit clinical trials of their drugs to the FDA to demonstrate the drug’s safety and effectiveness. However, drugmakers can conduct many clinical studies, choose the results they like best, and then submit only those results to the FDA for approval.
Gardasil was designed to prevent cervical cancer. Dozens of lawsuits have been filed by individuals claiming they suffered a range of injuries after taking the vaccine, including autoimmune disorders, premature ovarian failure, chronic fatigue, pain, and even cancer. Sick consumers across the country are now rightly seeking justice, but the FDA should serve as a safeguard before people suffer terrible consequences from faulty medicines.
#3 Tepezza: People suffering from Thyroid Eye Disease experience swelling, bulging, impaired vision, and pain. Tepezza was supposed to be a groundbreaking treatment for the autoimmune disease. Now, studies have revealed that as much as 65% of the people who’ve taken Tepezza may be suffering from permanent hearing loss.
Tepezza users shouldn’t have to choose between their vision and their hearing. The FDA approved the drug based on clinical trials with fewer than 100 patients and has yet to recall it.
#2 Philips CPAP Machines: In 2021 and 2022, Philips recalled many of their CPAP machines that users rely on to combat sleep apnea. Philips used a foam in the product’s design that could deteriorate over time, sending harmful particles directly into people’s lungs as they slept.
In 2023, users of these products continued to face serious threats to their health when some of the Philips replacement machines also had to be recalled.
#1 Tylenol: As early as 2013, there were studies indicating that taking Tylenol (acetaminophen, paracetamol) during pregnancy was linked to neurological disorders in children – including autism. Tylenol’s warning label says nothing about the risk.
This year, the FDA was asked by a federal court to provide their opinion on if Tylenol labels should provide a warning to pregnant mothers. In response, the FDA said it “respectfully declines” the judge’s invitation to comment on the safety of a drug it regulates.
Those are some of the disturbing ways the FDA continued to fail all of us in 2023. And there’s reason to believe these failures will continue next year, thanks to a loophole in the FDA approval process.
At any time, a drug company can request that the FDA fast track approval of the drug they’re developing. If the drug “fills an unmet medical need in a serious condition,” the FDA can decide to radically accelerate its review and approval process. The FDA is supposed to monitor drugs that they fast track for approval and continue to study them. In reality, this rarely happens, and consumers become test subjects.
For 2024, consumers should resolve to advocate for themselves. If you have any concerns about the medicine you’re taking or the medical device you’re using, ask your physician questions.
And if you believe a drug, product, or medicine is making you sick – even if your side effect doesn’t appear on the label or your physician downplays your concerns – don’t hesitate to stand up for your well-being, even if the FDA failed to.
Jennifer Taylor is an attorney at The Law Offices of James Scott Farrin, the largest plaintiff’s firm in North Carolina.
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