Why does the FDA take so long to approve new medications.
You will learn:
- What holds up new treatments for diseases and conditions
- How long the FDA sits on a known safe medical medication before it is released to the public.
- Why safe and effective drugs are NOT approved by the FDA
- Why doctors are forced to use medications off label
- How you can help
During my 44 years of medical practice, I have encountered conditions for which there is no approved medication or surgical treatment available as recognized by the American College of OBGYN or the FDA. This situation can present challenges both for physicians managing these patients and for individuals seeking relief from their symptoms.
This issue is not often addressed on Dr Oz, in the news, or at medical conferences. For many conditions, physicians wait for the development of approved medications or treatments, and in the meantime may inform patients that there is currently no treatment or cure available. Some doctors may attribute a patient’s concerns to aging, stating that it is a universal experience. While this may be accurate, such explanations may not provide comfort to patients seeking solutions to their symptoms. This lack of helpful guidance can discourage individuals from seeking medical care when they feel their concerns are not acknowledged.
This seems to result from insurance companies prioritizing cost savings by minimizing patient care. Every year insurance companies decrease what they pay doctors for their services, while their expenses go up, and the Government requires more and more work behind the scenes like HIPPA, OSHA, and Clia requirements that costs more to deliver the same service. If you have a problem with the time your doctor spends with you then blame the insurance companies whose profits rise every year…Soon doctors will do what I do and only take cash. The practice of medicine is not working in a free market.
While insurance limits the prescriptions of medication to those meds that are FDA Approved, the FDA and medical specialty colleges often delay approval of new, low-risk treatments for up to 20 years after their effectiveness is demonstrated. This lengthy process should be reconsidered to treat people who are ill and suffering, now.
There is plenty of research in the medical journals that explain the safety of new and effective treatments that can save peoples’ lives that are not FDA approved yet. The FDA is not interested in expediting the release of medication/ devices quickly to those people who need help now. They drag out the testing of a medicine that has been effective for years and may or may not approve it.
On the flip side they have approved many drugs that later are found to have severe side effects, and they just change the warnings on the medication inserts. They don’t take them off the market except in severe cases.
Drugs that have worked treating patients successfully are being used but are not FDA approved. These “grandfathered drugs” don’t need to go through the testing that new drugs go through because they work with few well-known risks. I use many if these medications because they are inexpensive for my patients and are often more effective than new meds for the same problem. One of the drugs that the FDA has not had to approve is Armour Thyroid, a natural thyroid replacement.
My experience with treatments not approved by the FDA
Armour Thyroid: Armour Thyroid (AT) has been prescribed by doctors to replace thyroid hormones for about 100 years. It is natural, made from Pig thyroid. It only comes from “medical Pigs” that are raised for medical purposes. We use medical pigs for skin grafts, and other parts of the pig to treat human diseases like heart valve replacements.  Armour Thyroid is composed of the four thyroid hormones that humans make: T4, T3, T2, T1. The synthetic thyroid replacement, Synthroid/levothyroxine is only T4. The active form of thyroid is T3, and it requires an enzyme to convert T4 into T3. If a person can’t convert T4 into active T3 then nothing improves except the blood levels of T4, and TSH.
The majority of women cannot convert T4 into T3. Therefore, if they take Synthroid or levothyroxine and their doctor only checks their TSH level and not the level of free T3 and free T4 to see if the Thyroid is working, then women are told that they are healed, yet they know they are not because none of their low thyroid symptoms are resolved.
When this happens, doctors tell female patients that it is all in their heads and dismiss us when we tell them we are not cured with this synthetic T4 medication. Yet Synthroid is a chemical, and AT is natural from medical pigs, so the FDA is trying to Bann the only drug that has successfully treated millions of women. PS. Synthroid was not tested on women like many other drugs that were passed through the FDA before 2014!
If you think this is a small problem, think again. Thyroid hormones are vital to human life, and the thyroid gland requires Iodine in the diet. The Midwest US has no Iodine in the soil or water. Therefore, this area is overburdened with hypothyroidism. I have been on AT for 50 years without complication and I have prescribed it thousands of times ever since I went into private practice. AT works to relieve the symptoms of hypothyroidism for women and men, and it works better for women that the “new” drug Synthroid/levothyroxine, which is FDA approved.
You ask how could the FDA approve a drug that doesn’t successfully treat women? It is because Synthroid was not tested on women! Until 2014 the FDA did not test women in the required drug trials. AT works for us (women), Levothyroxine does not. Now the FDA wants to ban AT. It is not approved because it was around for decades before they started testing medications like they do now, and the history of successful treatment should stand on its own merit!
Example 2:
Bio-Identical Hormones BIH: BIHs had not been approved by the FDA until recently and there was no announcement that they are now approved for women who have hormone deficiency symptoms or postmenopausal symptoms. Most doctors and women who have been afraid of the only hormones that can help them, bioidentical hormones, haven’t yet been told that NOW, FINALLY the medical colleges and the FDA finally have quietly approved BI hormones. There are no pure estradiol and pure testosterone pellets that are made by a drug company for women. My patients get their estradiol and testosterone pellets from a compounding pharmacy.  I have been prescribing BIH since 1985 without FDA approval because the oral estrogen formulations that were available at pharmacies caused weight gain and put women at high risk for blood clots. Non-oral BI hormones have fewer risks than FDA approved estrogens. I waited more than 45 years for the FDA to approve BI hormones for treatment of women. All those women in the last 45 years who were taking FDA approved estradiol and those who couldn’t tolerate them have been harmed by FDA goals of never approving compounded or bio-identical hormones. The delay has harmed 50% of American women.
Example #3 Devices for Weight Loss
I was involved in the discovery and testing of a unique device that stimulated acupuncture points with a TENS-unit-type patch connected to your cell phone for easy adjustment of your hunger or “fullness”. The FDA requires testing to approve any new device so the group of investors I was part of had to invest thousands of dollars for a device we already knew worked.
The FDA told the investigators of all new devices who they should test, who they can’t have in the study, and how long the testing should take. I found their parameters for the study of this device to be unrealistic. The women in our test group could not be taking hormones of any kind (birth control, ERT, HRT), and could not be on antidepressants, could not have diabetes or insulin resistance or be on any drug that assisted in weight loss. These women subjects had to be a certain BMI (level of obesity) and had to be tested repeatedly with weight and body composition measurements
None of my patients who needed weight loss could participate. Most GYN patients are on some medication or supplement, so the FDA made this study of our device so narrow that REAL WOMEN weren’t tested!
Sadly, we lost many women in the control group from the study because they were NOT losing weight while the ones on the device were obviously dropping pounds, so we had trouble maintaining test subjects. The testing phase of this simple device took 7 years!
Our device works and no one will ever know about it or be able to use this non-medicinal weight loss device because when the FDA rejects your device you will be breaking the law if you produce and sell it directly to the public.
It has no side effects or dangers..it just controls the amount you eat with stimulation of an acupuncture point.
There are many ways to change this situation, and it takes years and billions of dollars to change the whole system of bringing treatments to patients quickly. I’m afraid I won’t see a revolution of the way we bring medicines and devices to market during my lifetime. Currently there is a 17-year delay between proving a drug or device works for a particular illness or condition and when it becomes available to doctors and patients.
So what do we do in the meantime? I seek treatments for patients who are unresponsive to traditional medicine by reading journals like Life Extension, that inform doctors and patients alike about new effective solutions for common medical complaints and diseases that the FDA has ignored or stymied with endless drug trials. Life Extension Magazine highlights studies on new medications for diseases without an FDA approved solution and publicizes diagnostic tests often overlooked by mainstream publications because they are not yet FDA approved.
The medical journals I read (New England Journal of Medicine, JAMA, Menopause, Metabolism and Endocrinology, Journal of Age management, to name a few) offer treatments for orphan diseases or even common problems that haven’t been blessed by the FDA. It takes an average of 17 years from the culmination of research on a new drug, test or device until it is approved for use by the public!
At the end of this Blog, I will give you a link to make your voice heard by signing a petition to shorten the approval of new treatments and medications from the average of 17 years to 3 years! My patients don’t have time to wait for relief, and that may be the case for you as well.
If you want to do something to help, please click this link and let the FDA know how you feel.
Please sign a Petition to enact an amendment to the FOOD, DRUG and COSMETIC ACT, by going to:
This Health cast was written and presented by Dr. Kathy Maupin, M.D., Bio-identical Hormone Replacement Expert and Author. www.BioBalanceHealth.com • (314) 993-0963. Please subscribe to our YouTube channel and please check “ Like “. Follow us on Facebook and Instagram at BioBalanceHealth.
