Reconsidering the Meaning of FDA Approved?


Reconsidering the Meaning of FDA Approved?By Dr. Richard Chern, M.D.

Thinking FDA approved means safe and non-FDA approved means unsafe is absolutely untrue? Did you know that over 20% of medications prescribed in the United States are non-FDA approved. So, if your doctor does not support a treatment for the simple reason that “it is non-FDA approved,” they either have little understanding of the treatment or little understanding of the FDA approval process.

Last week a physician told me hormones were unsafe because they are non-FDA approved. It’s upsetting to know that some physician’s still don’t understand the FDA approval process and don’t realize they likely write non-FDA approved prescriptions every day.

Here are few non-FDA prescriptions that you may recognize and some you will probably not. Many of these non-FDA approved prescriptions are considered the standard-of-care in medicine: Gabapentin for nerve pain, high dose amoxicillin for ear infections, antidepressant use longer than 12 weeks, birth control pills for irregular periods, acne, or endometriosis, Seroquel for insomnia, Diflucan in pregnancy, Bactrim for sinus infections, Clomid for male infertility, Mag Sulfate for preterm labor and preeclampsia, Cytotec to induce labor, steroids for premature babies lungs, and Botox was not approved for use in the forehead until 2017.

You may not recognize all of these drugs, but every physician should. They should also recognize that these are commonly prescribed even though they are non-FDA approved.
Getting FDA approval costs about 20 million dollars. Once approved, drug companies need to make that money back and more. There is no incentive to get FDA approval for a drug that is already generic or already available to physicians to prescribe for some other use.
Waiting for FDA approval also causes countless deaths. Beta-blockers help prevent heart attacks but weren’t approved for almost 15 years after trials showed benefit. It’s believed thousands of people died needlessly because of the delay in FDA approval. Additionally, hundreds of FDA approved drugs have been pulled from the market because it was later discovered they could be harmful or even cause death. Zantac is only the latest on that list.
So, if your doctor tells you to avoid treatment because it is not FDA approved, you should ask them if every medication they prescribe is FDA approved. I am confident they have no idea.

The hormones I prescribe are 100% natural and 100% bio-identical. That means these are the same hormones your body has been making for the last 30, 40, 50 years or more. The decrease in these hormones is likely the cause in much of our aging and disease. Doesn’t it make sense that replacing them will stop or reverse this process? Millions of patients across the United States receive our hormones and these patients see an increase in bone density, decreases in cholesterol, decreases in blood pressure, improvement in mood, sex drive, skin, hair and an overall improvement in health and vitality.

Dr. Richard Chern has been providing hormone therapy for more than 20 years and specializes in bio-identical hormones and thyroid optimization. Call 850-837-1271 today for an appointment.