provide over-the-counter sales of plan B to 
women 16 years and older. More than one year 
later, FDA expressed concern that the age- 
based sales distinction would present regulatory 
concerns, even though the amended application 
was the result of FDA’s recommendations. 
(C) According to court documents released 
on August 3, 2006, the director of FDA’s Of-
fice of New Drugs learned early in 2004 that 
the 
then-FDA 
Commissioner 
had 
decided 
against approval of Plan B before FDA staff 
could complete their analysis. 
(D) In another sworn deposition contained 
in the same court documents, one FDA official 
was told in January 2004 by the FDA Deputy 
Commissioner that Plan B needed to be re-
jected to ‘‘appease the administration’s con-
stituents’’. 
(E) In a letter and congressional testimony 
on August 1, the FDA Commissioner rec-
ommended that the appropriate age range for 
over-the-counter Plan B is 18 and older. This 
recommendation was established arbitrarily and 
acknowledged by FDA as not supported by sci-
entific data. 
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(F) A former FDA Commissioner testified 
in a sworn statement that he delayed approving 
over-the-counter sales of Plan B to determine 
how to restrict sales to young teens. 
(G) A study in the Journal of Obstetrics & 
Gynecology concluded that young women are 
able to use Plan B ‘‘effectively and safely with-
out health care provider intervention’’. 
(H) In November 2005, the Government 
Accountability Office found that the May 2004 
decision to deny OTC status to Plan B emer-
gency contraception ‘‘was unusual’’ in that the 
decision was made at a much higher level with-
in FDA than is usual practice, that the decision 
overruled recommendations by several levels of 
professional staff, and that the decision to limit 
OTC access to only those over a certain age 
was made prior to the completion of the regular 
review process. 
SEC. 3. OFFICE OF WOMEN’S HEALTH WITHIN FOOD AND 
DRUG ADMINISTRATION. 
(a) ESTABLISHMENT.—Section 903 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 392) is amend-
ed— 
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(1) by redesignating subsections (f) and (g) as 
subsections (g) and (h), respectively; 
(2) in subsection (h) (as so redesignated), in 
paragraph (1), by striking ‘‘subsection (f)’’ and in-
serting ‘‘subsection (g)’’; and 
(3) by inserting after subsection (e) the fol-
lowing subsection: 
‘‘(f) OFFICE OF WOMEN’S HEALTH.— 
‘‘(1) IN GENERAL.—There is established within 
the Office of the Commissioner an office to be 
known as the Office of Women’s Health (referred to 
in this subsection as the ‘Office’). The Office shall 
be headed by a director, who shall report directly to 
the Commissioner. 
‘‘(2) DUTIES.—With respect to activities of the 
Food and Drug Administration that relate to wom-
en’s health, the Director of the Office shall— 
‘‘(A) assess the level of agency activity; 
‘‘(B) set short-range and long-range goals; 
and 
‘‘(C) be responsible for activities related to 
prevention, research, education and training, 
service delivery, and policy development.’’. 
(b) PROHIBITION AGAINST TRANSFER OF FUNDS.— 
Notwithstanding any other provision of law authorizing 
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the transfer of funds within the Department of Health and 
Human Services or within the Food and Drug Administra-
tion, any funds appropriated for the Office of Women’s 
Health within the Food and Drug Administration shall not 
be transferred to any other agency or office. 
SEC. 4. SCIENCE ON BREAST IMPLANTS. 
(a) CLASSIFICATION OF BREAST IMPLANTS.—Section 
513(f) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360c(f)) is amended by adding at the end the fol-
lowing: 
‘‘(6) A breast implant (as such term is defined in sec-
tion 515A(f)) is deemed to be a class III device and shall 
be required to have an approval under section 515 of an 
application for premarket approval. This paragraph ap-
plies to a breast implant irrespective of whether the im-
plant has been cleared under section 510(k) before the 
date of the enactment of this paragraph.’’. 
(b) DEMONSTRATION OF SAFETY.—Subchapter A of 
chapter V of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 351 et seq.) is amended by inserting after sec-
tion 515 the following section: 
‘‘SEC. 515A. BREAST IMPLANTS. 
‘‘(a) DEMONSTRATION OF SAFETY FOR LIFE OF THE 
DEVICE.— 
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‘‘(1) IN GENERAL.—In the case of an applica-
tion for a breast implant filed under section 515, the 
Secretary shall not find that a reasonable assurance 
of safety has been shown under section 515(d)(2) 
unless, prior to the approval of the application, the 
applicant involved has established— 
‘‘(A) the life of the implant; and 
‘‘(B) that safety has been demonstrated 
for the life of the implant. 
‘‘(2) PREVIOUSLY APPROVED APPLICATIONS.— 
In the case of an application for a breast implant 
approved under section 515 before the date of the 
enactment of this section, the breast implant is 
deemed to be unsafe for purposes of section 
515(e)(1)(A), and the Secretary shall withdraw ap-
proval of the application for such breast implant 
under section 515(e), unless the holder of the appli-
cation establishes the life of the implant and dem-
onstrates that safety has been demonstrated for the 
life of the implant. 
‘‘(b) GUIDANCE FOR CLINICAL CARE, REMOVAL AND 
REPLACEMENT.— 
‘‘(1) IN GENERAL.—In approving an application 
for a breast implant under section 515, the Sec-
retary shall— 
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