Fight FDA Restrictions on Hormone Pellets

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Dr. Kathy Maupin discusses recent legislation proposed to the FDA that would limit the availability of hormone pellets that are used in her practice, as well as what you can do to help fight these decisions.

Once again, the FDA is threatening to limit our ability to get our much needed bio-identical hormone replacement. Please support us by submitting a comment on the FDA’s website against the proposal to prevent compounding pharmacies from sending prescriptions across state lines. I am offended at the arrogance of our government to prevent millions of Americans from getting the medication that they need.

Since I buy my pellets from two different compounding pharmacies that are both in another state, and I prescribe compounded medications from pharmacies in other states for my patients, this means that my patients and I would not be able to obtain the pellets that I have been using for over thirteen years. Hormone pellets are difficult to produce and must be uniform for each dose to dissolve at a predictable rate. There are no pharmacies in my state (I have tried their pellets personally) that can equal the quality of the two pharmacies in Colorado that I prescribe hormone pellets from.

I find this to be an unconscionable intrusion of regulation where none is needed. The pharmacies that I use are outstanding and have excellent safety records and standards. I have no complaints about the efficacy and functionality or safety of the pellets used in my practice. The idea that pharmaceutical companies are pushing the FDA to restrict my access after thirteen years of using these pharmacies is highly offensive. It makes me wonder why are they asking for tis change.

Compounding pharmacies are important and special. They don’t only produce excellent individualized prescriptions, but they fill a huge gap in available pharmaceuticals that the major pharmaceutical companies neither can, nor want to fill. Compounding pharmacies supply orphan drugs that are not available through normal pharmacies because they are too expensive to make for a small population. Compounders also provide necessary drugs that are back-ordered or held up by FDA red tape. Drugs as simple as B12 shots were unavailable last year, and lidocaine was not available anywhere in the US a few years ago. Now, hospitals can’t even get IV bags of normal saline. This is where the compounding pharmacies step in and actually save the lives and meet the needs of patients throughout the US. If they were small pharmacies in our state, it would be too expensive for them to produce, but the national compounding pharmacies step in to fill the gap created by traditional pharmacies and the government. Why would anyone limit that?

If the FDA moves in to restrict the ability of compounding pharmacies to sell products throughout the United States, these pharmacies will go under. This will lead to a gap in serving the need for medicines that the major pharmaceutical companies are not filling.

A similar problem created by the FDA, is that of how they force patients to stop using a drug that their doctor feels they need by restricting the number of pills manufactured by that company. This is a common problem with ADHD drugs. It ends up causing a shortage and only the patients who are motivated, or have enough time and money to shop around can even fill their prescription. I am sickened at the fact that practicing medicine has become a bureaucratic process.

My thinking is that the FDA should not make its decisions based on the political ideology of its members (few of whom are practicing doctors), but rather on the scientific and medical facts. The most important consideration should be what is best for the patient, not what is best for big pharmaceutical companies, nor the conservative and sexist agendas of people invested in preserving the status quo by forcing all Americans to follow their ideals.

Watch this podcast for more information, then please click this link to let the FDA know that you oppose this new legislation. Please advocate for your continued right to obtain the compounded pellets from the best pharmacies in the US so you can stay productive and healthy. Mention in your own words the benefits you receive in terms of better health as well as any thoughts you might have regarding this issue after you watch the podcast. Thank you for your help with this.

Read my rebuttal to the FDA rule.

– Dr. Kathy Maupin