As I watch my energetic 8-year-old son sprint across the soccer field, I notice he begins to struggle with his breathing. He quickly substitutes himself out and makes his way to the sidelines, where I hand him his asthma inhaler. After two puffs, he’s back in the game, scoring a goal while high-fiving his teammates. But what if I told you that we could no longer trust the medications we give our children? The current administration is proposing significant changes to how the FDA approves drugs, and as both a mom and a pharma researcher, these changes worry me greatly. They should concern you too.
In the United States, every drug must be demonstrated as both safe and effective before it receives FDA approval. This means that the asthma inhaler I give my son should not only be safe for him but also effective in managing his asthma symptoms. Sounds reasonable, right? Who would want to use drugs that are unsafe or ineffective? Unfortunately, before the 1970s, this was a reality. FDA regulations ensure our medications are both safe and effective, yet the Trump administration is attempting to roll back critical regulations designed to protect us and our children.
The administration aims to allow drugs to be marketed with proven safety but unproven efficacy. Let me emphasize that: they want to permit the sale of medications that have not been shown to work. This could mean if you or your child suffers from asthma, allergies, or even cancer, you might be prescribed a medication that is heavily advertised but lacks evidence of its effectiveness.
Why is this so troubling? Because drugs are not like other consumer products, such as shoes or lip balm. They require rigorous testing on humans to validate their efficacy, following established protocols. While I appreciate the administration’s focus on safety, I find it perplexing to advocate for medications that may not actually help. Imagine walking down the cough and cold aisle at a pharmacy, surrounded by countless “safe” products with no clear indication of their effectiveness. How would anyone know which ones to choose for real relief?
As I delve deeper into these potential FDA policy shifts, it feels like a false sense of choice. While the Trump administration promotes a narrative of consumer empowerment, the reality is that it primarily benefits large corporations at the expense of average consumers. They claim, “Your desired medications will hit the market faster!” But in reality, this doesn’t expand my options as a parent or a researcher. I don’t want to waste money on medications that aren’t proven to work. I certainly don’t want the so-called “choice” of giving my child an inhaler that fails to alleviate his asthma attack.
From a research standpoint, I have significant ethical concerns regarding the move to market drugs without comprehensive clinical trials. The drug development process is governed by international standards known as the International Conference on Harmonisation Good Clinical Practice (ICH GCP). The U.S. adheres to these guidelines because of the disturbing historical abuses in medical experimentation, including horrific abuses during the Holocaust. We need only look back to the 1972 Tuskegee Syphilis Study to see how our own government has failed its citizens in the past.
Our industry is heavily regulated for good reason; drugs are not standard consumer goods. The FDA is the global leader in drug approval and safety policing, and we should strive to maintain that gold standard. Other countries even model their agencies after ours—Taiwan has its own FDA, as does China. Why would we want to diminish our esteemed reputation in the world?
While the FDA approval process can be sluggish, the pharmaceutical industry is actively seeking to expedite it. In fact, the FDA has recently implemented faster review timelines, and the 21st Century Cures Act introduced 1,000 new positions to help manage the review backlog. However, due to the hiring freeze initiated by the Trump administration, these positions remain unfilled. This presents a frustrating catch-22: just as the FDA was improving, this administration is dismantling the necessary support.
We cannot afford to regress to a time of ineffective treatments and dubious cures. We need medications that are both safe and effective, delivered through responsible regulations and rigorous clinical trials. The FDA needs leadership that prioritizes consumer safety over corporate profits, ensuring that informed choices are available only when both safety and efficacy are verified.
If you believe that medications should be proven safe and effective prior to reaching the market, I urge you to contact your congressional representatives. Let them know you oppose the Trump administration’s FDA deregulation efforts. Advocate for the 21st Century Cures Act, request that the hiring freeze be lifted, and emphasize the importance of having all drugs proven safe and effective before they are sold to the public. This call could truly save lives.