SENATE CONCURRENT RESOLUTION 88--EXPRESSING THE SENSE OF CONGRESS THAT THE FOOD AND DRUG ADMINISTRATION'S (FDA) NEW POLICY RESTRICTING WOMEN'S ACCESS TO MEDICATIONS CONTAINING ESTRIOL DOES NOT SERVE THE PUBLIC INTEREST -- (Senate - June 10, 2008)
Mr. CORNYN (for himself and Mr. Bunning) submitted the following concurrent resolution; which was referred to the Committee on Health, Education, Labor, and Pensions:
S. Con. Res. 88
Whereas menopause is often a challenging transition for millions of women that requires specialized medications and medical treatments;
Whereas physicians prescribe a variety of pharmaceutical treatment options to treat women experiencing the symptoms of menopause;
Whereas individual women respond differently to different treatment options;
Whereas women's physicians determine on a case-by-case basis which treatment option is optimal for each woman;
Whereas many physicians prescribe compounded estrogen and other bioidentical hormone treatments for patients for a variety of reasons;
Whereas many physicians prescribe compounded estrogen treatments that contain estriol to treat menopausal and perimenopausal women;
Whereas estriol is one of three estrogens produced by the human body;
Whereas estriol has been prescribed and used for decades in the United States;
Whereas Congress has long recognized active pharmaceutical ingredients meeting standards set by the United States Pharmacopeia as permissible options for physician prescribing and pharmacy compounding;
Whereas the Food and Drug Administration (FDA) has announced that it will no longer permit compounding pharmacists to prepare medications containing estriol pursuant to a doctor's prescription;
Whereas insurers are now denying women reimbursement for compounded medications containing estriol as a result of the FDA's announcement; and
Whereas the FDA has acknowledged that it is unaware of any adverse events associated with use of compounded medications containing estriol: Now, therefore, be it
Resolved by the Senate (the House of Representatives concurring), That it is the sense of the Congress that--
(1) physicians are in the best position to determine which medications are most appropriate for their patients;
(2) the Food and Drug Administration (FDA) should respect the physician-patient relationship; and
(3) the FDA should reverse its policy that aims to eliminate patients' access to compounded medications containing estriol that their physicians prescribe for them, unless the FDA holds a public comment period on the issue and can document evidence of adverse events and other safety issues to justify such policy.