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Press Release: Sali – FDA Owes Women an Explanation for Ban on Hormone Replacement Therapy

June 19th, 2008 by Halli

From the Office of Rep. Bill Sali

WASHINGTON, D.C. – Congressman Bill Sali today called on the U.S. Food and Drug Administration (FDA) to explain why it has distributed warning letters to pharmacists across the country, restricting the compounding and sale of a hormone replacement therapy used by women.

“Compounding” is the process in which pharmacists produce custom medicines for their customers.

Sali’s call for answers comes after his meeting with several Idaho pharmacists concerned by the FDA’s action. Sali met last week with Barry Feely, a pharmacist from Hayden who expressed concern with the implications for his Idaho customers who depend on bioidentical hormone replacement therapy (BHRT) drugs

“Barry and I agree that the FDA’s action seems arbitrary and could negatively impact the healthcare of women who depend on this treatment,” said Sali. “Local pharmacies have historically been able to provide an effective treatment for women who need hormone replacement therapy. The FDA owes these women an explanation for its decision. And if the agency can’t offer up a valid explanation, tied to consumer safety and tied to real data, it should reverse its decision immediately.”

“For a small pharmacy, we see a large number of patients who are choosing to use BHRT drugs to manage their symptoms. They are using this therapy successfully and with a high level of safety. This decision by the FDA takes away our patients’ access and choice of medications to use to meet their needs,” Feely said.

Sali and Feely say they are concerned that the FDA’s action could lead to bans on other medicine compounding currently practiced at pharmacies across the country. Compounding allows pharmacies to provide custom treatments for patients based on their individual needs, for example, for hospice patients, for whom drugs are not typically manufactured in bulk.

In a letter to FDA Commissioner Andrew C. von Eschenbach, Sali said, “I am informed that the FDA is not aware of scientific evidence showing that BHRT drugs carry more or less risk than already approved alternatives. Information provided to my office on this issue suggests that the FDA warning letter was based specifically on considerations regarding the marketing of BHRT drugs and not based on health risks to the patient. Among other reasons, my constituents are concerned with this issue due to the difficulty associated with finding an effective treatment for their symptoms. Some of my constituents understand that the FDA’s decision has further restricted the options available to women seeking alternative forms of treatment.”

Sali asked the FDA to explain the process the FDA used to determine the limits on BHRT drugs that it imposed. Sali also asked whether the FDA is considering further limitations on BHRT drugs and for the agency’s position regarding the health and safety record of such drugs.

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