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Dr. Holtz Gets It Again! 45 Years ago my father was using compounded bio-identical and natural hormones on his 8 sisters and many daughters and 5,000 women in an OB/GYN practice. PMS and Peri-menopause was a non-issue with these patients. But Big Pharma controls medicine, medical journals and which new treatments are taught. They particularly destroy the ability of physicians to think — like putting a nausea drug through the skin in a cream — which is first grade compounding medicine and too complex for Big Pharma, who still offer pills to puking children!

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Patient's Right to Choose Bio-Identical
Hormone Treatment Needs to be Protected

Steven F. Hotze M.D.
President, Project FANS

Your right to choose the direction of your health care is under attack again. You must contact your U.S. Senator and Congressman today to ensure that you keep your freedom to choose natural, bio-identical hormones and other medications prescribed by your physicians and prepared by your pharmacist.

Senator Edward Kennedy (D-Massachusetts) with Senators Pat Roberts (R-Kansas) and Richards Burr (R- North Carolina) has drafted legislation which, if adopted, would eliminate your right, and that of your physician and your pharmacist, to choose your course of medical treatment. Instead, big government would determine what is best for you.

The FDA currently has no jurisdiction over state licensed and regulated pharmacies or physicians but Kennedy's bill would dramatically change this situation. This bill would give the FDA the authority to tell your physician what compounded medications he could prescribe and to dictate to your pharmacist what type of compounded medications he could prepare. If you are taking bio-identical hormones or other medications prepared by a compounding pharmacy, then you need to know that the Food and Drug Administration (FDA) plans to deny you the right to have these medications.

Kennedy's legislation is entitled the Safe Drug Compounding Act of 2007. It should be entitled the Elimination of Drug Compounding Act because that is what the drug companies and the FDA want to do. Always be on your guard when someone says, "I'm with the government and I'm here to help you." What this usually means is that your rights will be denied and your taxes will be increased. So it is with this bill.

Compounding pharmacy, the preparing of medications from bulk ingredients for individual patients, is the historic practice of pharmacy. A physician or veterinarian may decide to adjust the dose strength or the route of administration of a medication for a patient and then request that the pharmacist customize the prescription, tailoring it to the patient's need. This practice of drug compounding occurs in tens of thousands of pharmacies and hospitals every day across the country.

One of the primary reasons compounding pharmacy continues to be in great demand is because manufactured drugs are not individualized for the needs of each patient. In spite of this, the FDA has persistently attempted to eliminate this crucial patient service.

The 1938 Food, Drug and Cosmetic Act (FDCA) gave the FDA jurisdiction over pharmaceutical manufacturing of drugs but pharmacies were specifically exempted from FDA control. In 1938 all pharmacies practiced compounding. There is no federal license for pharmacies or pharmacists. The State Board of Pharmacy in each state has the sole jurisdiction over pharmacies located or doing business in that state.

Compounding is taught in every pharmacy school in the nation. The basics of compounding pharmacy are included in the standard textbooks used in Pharmacy Schools. The United States Pharmacopeia (USP), which has the congressional authority to establish standards for drug preparation, has established standards and practices for compounding medications by pharmacists. Most states, through their respective Boards of Pharmacy, have established standards and regulations which govern the practice of compounding pharmacy. The Pharmacy Compounding Accreditation Board (PCAB) has been established to ensure that the highest standards are followed in preparing compounded mediations.

Why would the FDA want to eliminate compounding pharmacy? Follow the money trail and you will see that the FDA and the drug companies work hand in hand. Nearly 20% of the FDA's annual income, over $300 million, is paid by the drug companies in the form of drug user fees. This is the money that that drug companies pay the FDA for approving their drugs. The pharmaceutical companies see compounding pharmacies as competition. "Big Pharma" believes in free enterprise as long as it has a monopoly. Kennedy's proposed legislation would let the drug companies use the hammer of the FDA to eliminate compounding pharmacies.

This restrictive legislation is being promoted by the FDA because it lost a law suit to a coalition of pharmacies who proved that the FDA had been acting illegally. Big Pharma, including Wyeth, the manufacturer of Premarin and PremPro, also support this legislation as a means to eliminate competition from compounding pharmacies which specialize in natural hormone prescriptions for women and men.

On August 31, 2006, in Midland, Texas, a coalition of compounding pharmacies won a landmark case against the FDA. There, Federal District Judge Robert Junell issued a ruling that compounded preparations were legal and that compounding pharmacies had been exempted from FDA jurisdiction since the Food, Drug and Cosmetic Act of 1938. This decision ensured that the practice of pharmacy would remain under the authority of the respective state boards of pharmacy. More importantly, it guaranteed that patients would continue to have access to customized prescriptions prepared at compounding pharmacies. The FDA, which had been illegally attempting to control state regulated pharmacies for more than a decade, was infuriated by this decision. The FDA appealed the decision to the 5th Circuit Court of Appeals and then encouraged Senator Kennedy to draft legislation that would reverse the ruling.

Senator Kennedy is the chairman of the Senate Health, Education, Labor and Pension (H.E.L.P.) Committee. He plans to bring his bill before the committee on March 28, 2007. So you need to act immediately to protect your rights.

Take Action – Contact your U.S. Senators and Congressmen by e-mail, phone and fax today.

Ask your senators and congressmen to protect your right to choose bio-identical hormones and other compounded medications by defeating Senator Kennedy's misguided bill on compounding pharmacy.

www.projectfans.com

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Sample Email or FAX Letters to Congress

Sample Email or FAX Letter for Those taking Bio-identical Hormones or other Compounded Medication

To be Sent to Senators and Congressmen in Opposition to the Kennedy Bill on Drug Compounding

(Please reword and personalize your letter.)


Dear Senator or Representative ___________:

Because of your concern for protecting patients' rights, I wanted to bring to your attention my concern over legislation entitled the Safe Drug Compounding Act of 2007 which has been drafted by Senator Edward Kennedy. Senator Kennedy is planning to quickly introduce this proposed legislation with co-sponsors, Senators Richard Burr and Pat Roberts.

My physician has prescribed bio-identical hormones to treat my health conditions and I am feeling so much better than I did on the drugs which I had previous taken. The type that he prescribed can only be purchased from a compounding pharmacy.

Drug Companies, particularly Wyeth, the maker of Premarin, have been using the FDA to try to eliminate compounding pharmacies which are their competitors.

If the Safe Drug Compounding Act were to become law, then some bureaucrat from the FDA might restrict and possibly even deny my access to vital compounded medications which my doctor has determined that I need.

Compounding pharmacies are licensed and regulated by the states and it should stay that way. We don't need big government telling my doctor or me that we cannot use bio-identical hormones.

Please protect my right to choose bio-identical hormones and other compounded medications by defeating Senator Kennedy's misguided bill on drug compounding pharmacy.

Sincerely yours,

Your name


Please forward this letter to your family and friends. We need to flood the Congress with e-mails, phone calls and faxes.


Allergy Desensitization Therapy To be Sent to Senators and Congressmen in Opposition to the Kennedy Bill on Drug Compounding.

(Please reword and personalize your letter.)


Dear Senator or Representative ___________:

Because of your concern for protecting patients' rights, I wanted to bring to your attention my concern over legislation entitled the Safe Drug Compounding Act of 2007 which has been drafted by Senator Edward Kennedy. Senator Kennedy is planning to quickly introduce this proposed legislation with co-sponsors, Senators Richard Burr and Pat Roberts.

My physician uses allergy desensitization therapy to treat me for my allergic disorders. I am feeling so much better than I did on the drugs which I had previous taken. This treatment is only available through my physician's office.

If the Safe Drug Compounding Act were to become law, then some bureaucrat from the FDA might restrict and possibly even deny my access to this vital allergy treatment which my doctor has determined that I need and from which I have benefited.

Physicians are licensed and regulated by the states and it should stay that way. We don't need big government telling my doctor or me that we cannot use allergy desensitization treatment.

Please protect my right to choose allergy desensitization treatment by defeating Senator Kennedy's misguided bill on drug compounding.

Sincerely yours,

(Your Name)


Please forward this letter to your family and friends. We need to flood the Congress with e-mails, phone calls and faxes.


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