As a Mom and Pharma Researcher, I’m Seriously Worried About Trump’s FDA Plans

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As my energetic 8-year-old son zips across the soccer field, I notice he’s starting to struggle with his breathing. He takes a quick break, runs to the sidelines, and I hand him his asthma inhaler. A couple of puffs later, he’s back in the game, scoring a goal and celebrating with his teammates.

But what if we couldn’t trust that the medications we give our children actually work? What if I told you that the current administration is looking to shake up the FDA’s drug approval process? As both a concerned mom and a pharmaceutical researcher, this is a major issue for me—and it should be for you too.

In the U.S., every drug must demonstrate both safety and effectiveness before being approved by the FDA. The inhaler I give my son has to be safe (meaning it won’t harm him) and effective in managing asthma (meaning it actually helps control his symptoms). Seems like basic logic, right? Who would willingly take unsafe or ineffective medications? Yet, before the 1970s, this was a reality. FDA regulations are what keep our drug supply secure and effective, but the Trump administration is pushing to roll back essential regulations designed to protect us and our kids.

The administration wants to allow drugs to be sold without proving their effectiveness. Let me repeat that: They want to let drugs hit the market without any proof that they actually work, all in the name of getting them out faster. Imagine if you or a loved one, battling conditions like asthma, allergies, or even cancer, were prescribed a drug that was heavily advertised but untested for effectiveness.

Why is this a big deal? Because medications aren’t like trendy sneakers or flavored lip balm; they require rigorous testing on humans to confirm their effectiveness. While I appreciate that the administration acknowledges the need for safety, why should anyone waste time and money on treatments that don’t work? I can picture the cold and cough aisle at CVS filled with medications labeled “safe” but lacking any guarantee of effectiveness. How would anyone know what to choose?

The more I delve into this potential shift in FDA policy, the more it feels like a false sense of choice. The administration claims they’re empowering consumers, but in reality, they’re giving more power to large corporations at the cost of the consumer. They say, “You’ll get the medicines you want sooner!” But what good is that if those medicines haven’t been proven to work? I don’t want to pay for ineffective treatments that could leave my child without the relief he needs.

As a researcher, I’m deeply troubled by the idea of moving forward with marketing drugs without thorough testing. The drug development process is governed by international standards called International Conference on Harmonisation Good Clinical Practice (ICH GCP). The U.S. adheres to these standards because of the dark past involving unethical human experiments, like those conducted by the Nazis. We can’t afford to overlook our history; after all, as recently as 1972, we let our own citizens suffer from curable diseases just to study the effects.

My industry is heavily regulated because drugs are not your average consumable items. The FDA serves as the watchdog of drug approval globally, and we should aim to be the gold standard. Wouldn’t we want to remain that way?

Even though the FDA approval process can be slow, it is improving. Last year saw a faster review timeline than we’ve experienced in years, thanks to the 21st Century Cures Act, which allocated 1,000 new positions to help clear the backlog. But guess what? Thanks to the hiring freeze imposed by the Trump administration, those positions are sitting empty. It’s a classic catch-22. The FDA was making progress, and now the administration is dismantling what’s needed to keep it functioning, endangering patient safety along the way.

We cannot afford to regress to the days of ineffective treatments and flashy infomercials selling dubious cures. We need safe, effective medications supported by responsible regulations and trusted clinical trials. The FDA needs leadership that prioritizes consumer needs over corporate profits, and that genuine choice can only exist when consumers are fully informed about both safety and efficacy.

If you believe that drugs should be proven safe and effective before being sold, reach out to your congressional representatives. Tell them you oppose the Trump administration’s attempts to deregulate the FDA. Advocate for the 21st Century Cures Act and demand that those 1,000 reviewer positions be filled immediately. Your voice could help save a life.

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Summary

As a mom and researcher, I’m alarmed by proposed changes to the FDA’s drug approval process under the Trump administration. Plans to allow drugs to enter the market without proof of effectiveness could endanger patients and undermine consumer safety. It’s crucial to advocate for regulations that ensure medications are both safe and effective, protecting our families in the process.