[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H. Con. Res. 342 Introduced in House (IH)]
110th CONGRESS
2d Session
H. CON. RES. 342
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 HOUSE OF REPRESENTATIVES
May 6, 2008
Mr. Ross (for himself, Mrs. Emerson, Ms. Baldwin, Mr. Burgess, Mr.
Farr, Mr. Carter, and Ms. Giffords) submitted the following concurrent
resolution; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
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 House of Representatives (the Senate 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.
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