The past year has seen the Food and Drug Administration (FDA) struggle to keep up with the pace of public health changes. The pandemic encouraged the organization to move through the vaccine approval process quickly. While these vaccinations are vital to immediate public health, the same speed has started to creep into the agency’s approach to other approval requests.
For example, the FDA has recently approved a drug called Aduhelm. This drug, produced by biotechnology company Biogen, claims to treat Alzheimer’s disease. It was approved through the FDA’s “accelerated approval” rules, meaning that the drug was able to be approved before the agency received “all conclusive evidence.”
That’s a problem for two reasons. First, some medical experts looking at Aduhelm’s initial data believe that it’s not actually effective at treating Alzheimer’s like Biogen claims. In fact, at least one FDA panel actually rejected the drug before it received the accelerated approval. This means that Adulhelm can now be manufactured and prescribed despite a lack of evidence that it actually works.
Second, the company plans on charging $56,000 per year for the drug. The company predicts that this will generate multibillion-dollar sales numbers in the next few years. Yet, the fact remains that the drug has not yet been proven effective according to governmental standards. As a result, people, insurance companies, and government agencies may be forced to pay hundreds of thousands of dollars for a treatment that doesn’t actually work.
Obviously, this is bad for everyone. If this trend of rushing FDA approvals continues, then US patients can expect to suffer the consequences. Here’s what you need to know about FDA approvals, the dangers of rushing medication, and what to do if you’re prescribed one of these medications.
The Importance of FDA Approvals
The FDA was first formed to provide oversight for consumables. Before that, no single institution was responsible for monitoring what was sold as food and medicine. Companies could and did fill foods and drugs with substances like formaldehyde, cocaine, and wood because it was cheap. Of course, these companies didn’t tell consumers what they were doing, and people regularly died from consuming inedible substances.
The FDA sets standards for the things people can put in their bodies. They require companies to honestly list their ingredients and perform random checks at food manufacturing plants for accuracy and safety. They also have complete control over whether a pharmaceutical can be released for use in the US.
Before any pharmaceutical can be sold in the US, it needs to meet government standards for efficacy and safety. The FDA requires companies to perform rigorous studies that show replicable results. Furthermore, these studies have to show that the medication both does what it claims to do and does so without dangerous side effects. It’s designed to get as much data as possible so the FDA can announce if a drug is beneficial and who can use it safely.
The FDA approval process, when used correctly, is responsible for the generally safe and trustworthy state of medications in the US. Sometimes, though, the whole process isn’t followed, and people get hurt.
How the FDA Accelerated Approval Process Works
In the 1980s, the FDA responded to claims that the medication approval process took too long and instituted the accelerated approval program. This program is intended to get life-saving medications on the market more quickly. It requires the pharmaceutical company to complete fewer studies before selling the drug. Of course, the company must still finish the rest of the formal FDA studies, but that can occur after they’re already earning millions of dollars from a drug and hurting people.
Of course, pharmaceutical companies want to spend as little money testing a drug as possible. That’s why many attempt the accelerated approvals process, arguing that medications are life-saving without substantial evidence. Why? Because people who need these types of medications are desperate and willing to pay money for useless or dangerous drugs.
The Risks of Rushing Approvals
There are three potential outcomes of releasing a medication before it’s been thoroughly studied. The first and least likely result is the best: the drug does what it claims to do without side effects and potentially saves lives.
The other two outcomes are much worse. On the one hand, the drug could be ineffective, so patients who receive it aren’t getting the treatment they need. On the other, the drug could have horrible or fatal side effects. Small preliminary studies just don’t have the sample size to identify all the potential problems, so rare but deadly problems aren’t spotted.
For example, the medication Thalidomide was prescribed for morning sickness. It had been shown to reduce nausea safely in men. However, it wasn’t heavily studied in pregnant women. As a result, expectant mothers learned for themselves that Thalidomide also caused horrific birth defects. The Thalidomide scandal is actually what prompted the FDA to start approving drugs in the first place.
Other drugs that have had to be pulled off the market because of their dangerous side effects include:
- Vioxx and Bextra, painkillers that put people at risk for cardiovascular events
- Tysabri, a multiple sclerosis drug that’s connected to the severe brain infection PML
- Cylert, an ADHD medication that put patients at risk of liver failure
- Baycol, a cholesterol drug that caused fatal rhabdomyolysis
While all of these drugs received full FDA approvals, they still had hazardous, unexpected side effects. Even the large, safe, slower approval process can occasionally miss these details. If the FDA begins rushing the approval process, these kinds of problems will become much more common.
If You Suffer from Understudied Medications, Get Help
If you’ve faced serious side effects from a medication, you’re not alone. Understudied medications can lead to permanent disabilities and even death. You deserve to fight the pharmaceutical company that released an unsafe substance. Get the help of a qualified medical malpractice lawyer to start your fight today.
The right attorney can help you collect evidence of your problems, prove that the drug wasn’t studied effectively, and guide you through the legal system. The knowledge and experience of a true medical malpractice attorney is invaluable. You don’t have to do this alone. Reach out today to discuss your case.