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Defeat Legislation Allowing FDA Restrictions on Bio-Identicals

NEWS FLASH Senate Advances To Pass Bill Giving FDA Authority That May Lead to a Ban On Bio-identical Hormones and Other Compounded Medications


What is at stake?

Your bio-identical hormone prescriptions for estrogen, progesterone, and testosterone may no longer be available if this law passes.


Why do we need compounded medications?

Pharmaceutical companies have a long history of producing medications that optimize their profits. If a medication doesn’t do that, they are not interested, and if it competes with one of their products they will actively oppose it. That has been the case with bio-identical hormones.

The pharmaceutical industry has not been interested in providing drug doses that meet the needs of individual patients. That includes medications in a specific form that allows a particular patient to absorb it or in a specific small dosage that is shown to be superior by research or clinical science lab experience. An example is estradiol formulated as a vaginal cream because many patients cannot absorb it through the skin.

In addition, the pharmaceutical industry tends to focus on drugs that they can patent so as to increase their profit margin. Substances that are found in nature, like hormones, cannot be patented. As a result, these companies have been interested primarily in making synthetic hormones, which they can patent. However, research has shown that the risk profiles of these products are very different from those of bio-identicals. That is why we have depended heavily for years on reputable compounding pharmacies to make formulas with these natural ingredients – such as bio-identical estradiol, estriol, progesterone, and testosterone.


The Details

A US Senate subcommittee has approved a bill, S.959, that would give the FDA unprecedented control over compounding pharmacies. That legislation would include the right to ban bio-identical hormones and other compounded medications that patients depend upon. The full senate is expected to take up this legislation imminently. We need to let our voices be heard in Washington on this issue- see later in this article for easy links.


The Background

It was merely 5 years ago that the FDA tried to ban estriol, a mild form of bio-identical estrogen that is found in the body molecule and that is often used in bio-identical hormone molecule replacement therapy. This action was instigated by a large pharmaceutical company, Wyeth, which sought to restrict compounding and the financial competition that bio-identical hormones represent to their products. The attempt failed because the FDA did not have the legal authority to implement it. You may remember this newsletter alerting you at that time about the risk, and many of you signed petitions to your congressional representatives. Fortunately, the attempt was defeated.

The current Senate bill was crafted in response to a tragedy caused by contaminated injections distributed by the New England Compounding Center (NECC), which apparently violated numerous state and federal laws and which had no connection with bio-identical hormones. The FDA already has the authority to prevent the recurrence of such a tragedy, but Big Pharma is supporting the pending law as a vehicle to eliminate competition – including compounding pharmacies that do not even sell the type of injectables that caused the tragedy.

I am all for increased safety, but the NECC tragedy should not be used to deny you, me, and millions of patients the use of bio-identical hormones that many of us need and s959benefit from.

The U.S. Senate is expected to vote on S.959 within the next week. Please take time to act now to stop this bill from passing.



Tell congress what you think by going to: and send emails telling your congressman/woman:

“I am opposed to S.959 as it is currently written which gives the FDA unnecessary expanded authority that jeopardizes my successful medical treatment with safe and proven compounded medications.”

And, consider calling them. The general switchboard number for both Senate and House is 202-224-3121.

Thank you for taking time to ensure that bio-identical hormone therapy remains available for all of us in the future!