Science Over Politics Act - Requires the Commissioner of Food and Drugs to: (1) review the decision of the Food and Drug Administration (FDA) not to approve the application for the commercial distribution of the emergency contraceptive drug Plan B (levonorgestrel in 0.75 mg. tablet form) as an over-the-counter drug; (2) affirm that the decision was not politically influenced, was based on sound science, and conformed to FDA precedents and procedures; and (3) publish such affirmation in the Federal Register.
[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4377 Introduced in House (IH)]
108th CONGRESS
2d Session
H. R. 4377
To provide for the review by the Commissioner of Food and Drugs of the
process by which the Food and Drug Administration made the decision not
to approve the commercial distribution of the emergency-contraceptive
drug Plan B as an over-the-counter drug, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 17, 2004
Mrs. Maloney (for herself, Mr. Grijalva, Mr. Conyers, Mr. Jackson of
Illinois, Mrs. Capps, Ms. Millender-McDonald, Mr. Lantos, Mr. Crowley,
Ms. Jackson-Lee of Texas, Ms. Woolsey, Mr. Nadler, Mr. Filner, Ms.
Schakowsky, Mr. Frank of Massachusetts, Ms. Lee, Ms. DeLauro, and Mr.
Shays) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To provide for the review by the Commissioner of Food and Drugs of the
process by which the Food and Drug Administration made the decision not
to approve the commercial distribution of the emergency-contraceptive
drug Plan B as an over-the-counter drug, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Science Over Politics Act''.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) Emergency contraceptive pills (``ECPs'') are approved
for use by the Food and Drug Administration (``FDA'').
(2) Emergency contraceptive pills are a concentrated dosage
of ordinary birth control pills that can dramatically reduce a
woman's chance of becoming pregnant.
(3) If ECPs are taken within 72 hours of contraceptive
failure or unprotected sex, ECPs can reduce a woman's risk of
pregnancy by up to 89 percent.
(4) Emergency contraceptive pills do not cause abortion but
rather prevent pregnancy by inhibiting ovulation,
fertilization, or implantation before a pregnancy occurs.
(5) Emergency contraception cannot interrupt or disrupt an
established pregnancy.
(6) Increased use of ECPs could reduce the number of
unintended pregnancies and abortions by half.
(7) A 2002 study revealed that ECP use was likely
responsible for up to 43 percent of the decline in abortions
between 1994 and 2000, with ECP use preventing over 50,000
abortions in 2000 alone.
(8) Over-the-counter sales of ECPs would be particularly
beneficial for sexual assault victims as approximately 25,000
women per year in the United States become pregnant as a result
of rape. An estimated 22,000 of these pregnancies, 88 percent,
could be prevented if sexual assault victims had timely access
to emergency contraception.
(9) More than 70 organizations, including the American
Nurses Association, the American College of Obstetricians and
Gynecologists, the American Academy of Pediatrics, the American
Medical Association, the American Public Health Association,
and the Association of Reproductive Health Professionals,
support over-the-counter access to ECPs.
(10) On April 21, 2003, product manufacturers Women's
Capital Corporation submitted an application to the Food and
Drug Administration requesting to switch the emergency
contraceptive Plan B from prescription-only to over-the-counter
(``OTC'') status.
(11) ECPs meet all the customary FDA criteria for over-the-
counter status in that they are safe and effective, are not
associated with any serious or harmful side-effects, are easily
self-administered, and require no need for medical supervision.
Moreover, ECPs are not harmful to an existing pregnancy and
their use does not lead to riskier behavior or less frequent
use of other forms of contraception, has no potential for
overdose or addiction, is not harmful to an existing pregnancy,
is easily self-administered, and requires no need for medical
screening.
(12) FDA staff and experts appointed to the advisory
committees considered volumes of evidence showing that making
Plan B available over-the-counter was safe and effective for
women of all reproductive age.
(13) On December 16, 2003, a joint panel of the FDA's
Reproductive Health Drugs Advisory Committee and Non-
Prescription Drugs Advisory Committee voted 28-0 that Plan B
could be safely sold as an over-the-counter medication.
(14) On December 16, 2003, a joint panel of the FDA's
Reproductive Health Drugs Advisory Committee and Non-
prescription Drugs Advisory Committee voted 23-4 to recommend
that the FDA approve the application to make Plan B available
over-the-counter for women of all ages.
(15) The FDA's rejection of over-the-counter status for
Plan B on May 6, 2004, directly contradicted the overwhelming
weight of scientific evidence.
(16) The limited options offered by the FDA for future
consideration of over-the-counter sale of Plan B are not
warranted by the volumes of existing evidence and run counter
to the advice of the FDA's independent experts, staff, and
precedent.
(17) Evidence suggests that the FDA's decision resulted
from an unprecedented political takeover of what is supposed to
be an independent scientific review.
SEC. 3. FDA DENIAL OF OTC STATUS FOR EMERGENCY-CONTRACEPTIVE DRUG PLAN
B; REVIEW BY COMMISSIONER OF FOOD AND DRUGS.
(a) In General.--Not later than 30 days after the date of the
enactment of this Act, the Commissioner of Food and Drugs shall--
(1) review the decision of the Food and Drug Administration
not to approve the supplemental application submitted under
section 505(b) of the Federal Food, Drug, and Cosmetic Act to
obtain approval for the commercial distribution of the drug
Plan B (levonorgestrel in 0.75 mg. tablet form) as a drug that
is not subject to the requirements of section 503(b)(1) of such
Act (commonly known as an over-the-counter, or OTC, drug); and
(2) affirm, under penalty of law, that such decision--
(A) was not politically influenced;
(B) was based on sound science; and
(C) conformed to precedents and procedures of the
Food and Drug Administration.
(b) Publication in Federal Register.--The affirmation under
subsection (a) shall be made through a statement published in the
Federal Register.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line