tration, may publish in peer-reviewed journals and other 
scientific publications, and make oral presentations at pro-
fessional society meetings and other meetings of their 
peers, unless publication or presentation of the data is 
subject to Federal export control or national security laws 
or regulations, or is proprietary information. The right to 
publish or present such data cannot be waived by any 
agreement, policy, form, or condition of employment.’’. 
SEC. 5. PROVIDING FDA ADVISORY COMMITTEES WITH 
COMPLETE INFORMATION. 
Subchapter E of chapter V of the Federal Food, 
Drug, and Cosmetic Act, as amended by section 4 of this 
Act, is amended by adding at the end the following section: 
‘‘SEC. 566. PROVIDING ADVISORY COMMITTEES WITH COM-
PLETE INFORMATION. 
‘‘(a) IN GENERAL.—In conjunction with any hearing 
of an advisory committee of the Food and Drug Adminis-
tration, the Secretary shall, at the request of any officer 
or employee of the Administration whose employment du-
ties relate to the topic of the hearing, allow the officer 
or employee a reasonable amount of time to present to 
the advisory committee information on such topic. 
‘‘(b) TIMING OF PRESENTATION.—An advisory com-
mittee shall provide a period of time to an officer or em-
ployee for a presentation under subsection (a) that is sepa-
VerDate Aug 31 2005 
03:50 Feb 22, 2007
Jkt 059200
PO 00000
Frm 00018
Fmt 6652
Sfmt 6201
E:\BILLS\H1165.IH
H1165
hmoore on PROD1PC68 with HMBILLS
rate from the period of time allotted to the public for the 
hearing involved.’’. 
SEC. 6. PRESERVING SCIENTIFIC INTEGRITY. 
Subchapter E of chapter V of the Federal Food, 
Drug, and Cosmetic Act, as amended by section 5 of this 
Act, is amended by adding at the end the following section: 
‘‘SEC. 567. PRESERVING SCIENTIFIC INTEGRITY. 
‘‘(a) PROHIBITION.—An officer or employee of the 
Food and Drug Administration shall not direct any other 
officer or employee of the Administration— 
‘‘(1) to censor, distort, or suppress any sci-
entific research, analysis, opinion, or recommenda-
tion; or 
‘‘(2) to willfully disclose scientific information 
that is false, misleading, or incomplete. 
‘‘(b) APPROPRIATE
DISCIPLINARY
ACTION.—The 
Secretary shall subject any officer or employee who vio-
lates subsection (a) to appropriate disciplinary action 
(which may include dismissal). 
‘‘(c) REPORTING BY IG.—Not less than 1 year after 
the date of the enactment of this section, and annually 
thereafter, the Inspector General of the Department of 
Health and Human Services shall submit a report to the 
Congress— 
VerDate Aug 31 2005 
03:50 Feb 22, 2007
Jkt 059200
PO 00000
Frm 00019
Fmt 6652
Sfmt 6201
E:\BILLS\H1165.IH
H1165
hmoore on PROD1PC68 with HMBILLS
‘‘(1) identifying each disciplinary action under 
subsection (b) during the preceding 12 months; and 
‘‘(2) describing the circumstances of each such 
disciplinary action.’’. 
SEC. 7. TRANSPARENCY OF APPROVAL DECISIONS. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act, as amended by section 2(b) of this Act, is further 
amended by adding at the end the following: 
‘‘(p) TRANSPARENCY OF APPROVAL DECISIONS.— 
‘‘(1) SUMMARY
STATEMENT.—Not later than 
48 hours after the approval of an application filed 
under subsection (b) or (j), the Secretary shall pub-
lish a summary statement of the scientific basis for 
such approval and how the final decision balanced 
the risks and benefits. 
‘‘(2) CONTENTS.—A summary statement under 
paragraph (1) shall be dated and shall include the 
following: 
‘‘(A) A summary of the factual, scientific, 
and related issues considered during the ap-
proval process, including— 
‘‘(i) an explanation of the risks and 
the benefits of the drug involved; and 
‘‘(ii) the scientific rationale for the 
final decision. 
VerDate Aug 31 2005 
03:50 Feb 22, 2007
Jkt 059200
PO 00000
Frm 00020
Fmt 6652
Sfmt 6201
E:\BILLS\H1165.IH
H1165
hmoore on PROD1PC68 with HMBILLS
‘‘(B) Identification by name of each officer 
or employee of the Food and Drug Administra-
tion who participated in the decision to approve 
the application. 
‘‘(C) A description of— 
‘‘(i) any significant controversy or dif-
ference of opinion between two or more of-
ficers or employees described in subpara-
graph (B) relating to the decision to ap-
prove the application; and 
‘‘(ii) the resolution of each such con-
troversy or difference of opinion. 
‘‘(3) DISSENTING AND OTHER VIEWS.—Any of-
ficer or employee of the Food and Drug Administra-
tion who participates in the decision to approve an 
application filed under subsection (b) or (j) may sub-
mit a statement of views on the matter for inclusion 
in the applicable summary statement. Upon receipt 
of such a statement of views, the Secretary shall at-
tach the statement of views, without alteration, as 
an addendum to the summary statement. 
‘‘(4) SUBSEQUENT
CHANGES.—After publica-
tion of a summary statement under this subsection, 
the Secretary— 
VerDate Aug 31 2005 
03:50 Feb 22, 2007
Jkt 059200
PO 00000
Frm 00021
Fmt 6652
Sfmt 6201
E:\BILLS\H1165.IH
H1165
hmoore on PROD1PC68 with HMBILLS