As my 8-year-old soccer dynamo son races down the field, he starts to have a bit of trouble breathing. He subs out and heads to the sidelines, where I hand him his asthma inhaler. Two puffs later, he is back on the field. I cheer as he scores a goal, and he high fives all his friends.
But what if we could no longer be certain that the drugs we gave our children would actually work? What if I told you that our new administration is seeking to change the way drugs are approved by the FDA? As both a mom and a pharmaceutical researcher, those changes are of grave concern to me. And they need to be on your radar as well.
Right now, in the United States, all drugs must be proven both safe and effective in order to be approved by the FDA. So the asthma inhaler I give my son must be safe to take (meaning it will not hurt him) and also be effective in treating asthma (meaning it’s able to control symptoms). This seems like common sense, right? Who would want to take unsafe or ineffective drugs? But up until the 1970s, it was not all that uncommon to do so. FDA regulations keep our drug supply safe and effective, and yet the Trump administration is working to undo several key regulations that keep us and our children safe from harm.
The Trump administration wants to allow drugs to be sold with safety proven, but efficacy still not proven. Let me say that again: They want to allow drugs to be marketed with efficacy unproven in order to get drugs to market faster. It means that if you have asthma, or allergies, or even cancer, you could be given a drug that is well-marketed (think big splashy ad campaigns), but that has not been proven effective.
Why is that a problem? Because drugs are not like shoes, or lip balm, or hockey jerseys, or other consumable goods. Drugs have to be tested on human beings to demonstrate their efficacy, and there is a well-established protocol for doing so. Of course, we always want to make sure that a drug is safe, and I do appreciate that the Trump administration recognizes that. But why on earth would we want consumers to waste time taking agents that are not effective? I can only imagine the cough and cold aisle at CVS, filled with drugs of unknown efficacy. How would CVS even know what to stock? Imagine seeing box after box of medicine, all marked “safe” for your child, but being unable to tell which can actually help any symptoms that you seek to treat.
The more I learn about this potential policy shift at the FDA, the more it feels like a false sense of choice. While the Trump administration wants the consumer to feel empowered, their strategy actually empowers large companies at the expense of the consumer. They tell us, “The medicines you want will come to market sooner!” But that doesn’t actually give me more choice as a parent or as a researcher. I don’t want medications that have not been proven to work. I do not want to drain my wallet paying for medicines that will not stop my headache or cough. I do not want the “choice” to give my child an asthma inhaler that does not stop his asthma attack.
As a researcher, I have serious ethical concerns about moving forward with marketing drugs without thorough vetting through the proper clinical trial process. The drug development process is governed by international law called International Conference on Harmonisation Good Clinical Practice (ICH GCP). The U.S. adheres to ICH GCP because of the atrocities that were committed to humans at several dark points in history, including the unwilling experimentation on concentration camp prisoners by the Nazis. And we don’t need to look back very far in our own history to see how badly we treated our own citizens. As recently as 1972 — 25 years after the invention of penicillin — we left our own citizens to suffer from syphilis, a curable disease, just to see what would happen.
My industry is so heavily regulated and guarded because drugs are not standard consumable goods. The FDA is the pit bull of drug approval and policing for the world. We are envy of the rest of the world. Do you know what Taiwan calls their drug approval agency? The Taiwanese FDA. Do you know what China calls their drug approval agency? The Chinese FDA. Don’t we want to remain the gold standard? Why would we want to be anything else?
While the FDA approval process can be cumbersome and slow, and the pharmaceutical industry is begging for options to speed it up, now there is hope on the horizon. Last year, the FDA actually had a faster review timeline than they’ve seen in years. And last year, the 21st Century Cures Act was passed, and it is a huge boon to the industry. This gives the FDA 1,000 new positions that can help to address the backlog of reviews that it needs to get through.
But guess what? Due to the hiring freeze that Trump put into place, none of those positions can be filled now. This is truly a catch-22. The FDA was literally doing everything it could to get things right, and now the Trump administration is dismantling what is needed to make the agency function. Along the way, this new rollback of regulations will endanger patients.
At this point in time, with history as our guide, we cannot go backwards. We cannot go back to the days of sham medicines (sugar pills are safe!) and nighttime infomercials selling cures for all that ail us. We need safe, effective medicines brought to us through responsible regulations and the trusted clinical trial process. The FDA needs a leader who understands that profits for big companies should not come before the needs of consumers, and that true choice can only be had when a consumer is fully informed with both safety and efficacy information.
If you feel that your drugs should be proven both safe and effective before they can be sold to you, then call your congressional representatives, and let them know that you do not support the Trump administration’s deregulation of the FDA. Let them know that you support the 21st Century Cures Act, that you want the 1,000 reviewer jobs at the FDA unfrozen and filled immediately, and that you would like all drugs sold in the U.S. market to be proven both safe and effective prior to marketing. I know we all have lots of calls to make right now, but this call could be one that saves a life.