Compounders On Capital Hill – PharmaHealth Lobbys to Protect Access to BioIdentical Hormones
May 2008
DARTMOUTH, MA – Compounding pharmacists from across the nation stormed Capitol Hill this month to lobby members of Congress to protect access to commonly compounded bioidentical hormones. Richard Brisson, B.S., R.Ph. and Philip Falzarano, R.Ph., of PharmaHealth Pharmacy in Dartmouth, made the trip to Washington, D.C. While meeting with various elected officials and their staff, Mr. Brisson, Mr. Falzarano and their colleagues discussed the value of pharmacy compounding and bioidentical hormone replacement therapy (BHRT). Earlier this year, the Food and Drug Administration (FDA) asserted a new policy to deny women’s access to bioidentical hormones.
Wyeth Pharmaceuticals, the number one manufacturer of synthetic hormone products, petitioned the FDA to restrict the compounding of medications containing estriol, an estrogen produced by the human body. Like many commonly prescribed drugs, estriol has a monograph from the U.S. Pharmacopeia (USP), but is not a component of an FDA-approved drug. When it passed the FDA Modernization Act in 1997, Congress clearly indicated that drugs with a USP monograph could be compounded.
"This trip gave us a chance to have our voices heard by members of Congress," said Mr. Brisson. "With help from thousands of patients and prescribers who called and wrote their members of Congress, our voices were heard loud and clear on Capitol Hill."
The trip to Washington, D.C., dubbed Compounders on Capitol Hill, was the 14th annual trip coordinated by the International Academy of Compounding Pharmacists (IACP).
Mr. Brisson and Mr. Falzarano’s visit to Congress came at a particularly critical time for their business, and similar compounding pharmacies across the country. Last month several key representatives introduced H. Con. Res. 342. The bipartisan resolution states that "the Food and Drug Administration's (FDA) new policy restricting women’s access to medications containing estriol does not serve the public interest" and called on the FDA to "reverse its policy." Pharmacists were greeted with an overwhelming sense of support from their members of Congress regarding H. Con. Res. 342.
"This is an important step for compounding pharmacies like ours. We fill an important void for hundreds of thousands of women whose needs can’t be met by manufactured medicines. They rely on us and I simply don’t know where they would get the medicines they need if we couldn’t compound with bioidentical hormones anymore," said Mr. Falzarano, R.Ph. at PharmaHealth.
Pharmacy compounding is a pharmacy practice that enables doctors to prescribe customized pharmaceutical treatments for patients when one-size-fits-all manufactured products are inappropriate. While pharmacy compounding is regulated by state boards of pharmacy, pharmaceutical manufacturers are pushing for onerous, federal restrictions that would restrict patients’ access to needed medications.
For more information about PharmaHealth Pharmacy, which has locations in New Bedford and Dartmouth, please call 508-998-8000 Monday through Friday 9am-6pm or Saturday 9am-1pm.
