[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. Con. Res. 88 Introduced in Senate (IS)]







110th CONGRESS
  2d Session
S. CON. RES. 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.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             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

_______________________________________________________________________

                         CONCURRENT RESOLUTION


 
        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.

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.
                                 <all>