[Congressional Record (Bound Edition), Volume 154 (2008), Part 9]
[Senate]
[Pages 11964-11965]
[From the U.S. Government Publishing Office, www.gpo.gov]




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

  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;

[[Page 11965]]

       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.

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