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shall also include a comparison of the performance of the
Food and Drug Administration with that of agencies per-
forming similar functions for other countries and an eval-
uation of the effect of the Food and Drug Administra-
tion’s performance on the competitiveness of the regulated
American industries.
‘‘(2)(A) The members of the commission shall include
the nation’s leading medical experts, medical society rep-
resentatives, scientific and health policy authorities, and
representatives from the trade associations for the regu-
lated industries and from voluntary health associations.
‘‘(B) Members of the commission shall serve at the
discretion of the Secretary from year to year with no fixed
term.
‘‘(C) The Secretary shall pay members of the com-
mission at an appropriate level commensurate with the
services they provide.
‘‘(3)(A) The commission shall issue a report to the
Secretary and the Congress annually on the performance
of the Food and Drug Administration. The Food and
Drug Administration shall be given an opportunity to re-
view and respond to the report before it is submitted to
the Secretary and the Congress.
‘‘(B) As part of its annual report under subparagraph
(A), the commission shall recommend personnel and policy
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changes to improve the performance of the Food and Drug
Administration in order to meet its mission as set forth
in subsection (d).’’.
SEC. 13. APPEALS.
Section 903 (21 U.S.C. 393), as amended by section
12, is amended by adding the following new subsection
at the end thereof:
‘‘(g)(1) The Secretary shall establish within the Food
and Drug Administration a drug and biologics policy ap-
peals committee consisting of the director and deputy di-
rector of the center for drugs and the director and deputy
director of the center for biologics. The appeals committee
shall meet to hear and consider any dispute raised by an
individual who wishes to contest a policy matter relating
to drugs or biologics. The appeals committee shall meet
to hear the individual within 15 days of receiving the re-
quest from the individual and shall decide the matter with-
in 10 days after the hearing.
‘‘(2) The Secretary shall establish standing panels of
qualified experts who are not employees of the United
States Government or of any State or local government
for the purpose of hearing appeals by individuals who have
exhausted their informal appeals within the Food and
Drug Administration and who wish to contest the action
or failure to act by the Food and Drug Administration
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in a particular matter. The Secretary shall establish an
appeal procedure that assures immediate access to such
a panel and prompt conclusions and recommendations by
the panel. Following the conclusions and recommendations
of the panel, the official of the Food and Drug Adminis-
tration who reports to the Commissioner of Food and
Drugs and is the director of the component responsible
for regulation of the matter shall personally review the
matter, in light of such conclusions and recommendations,
and shall make a final decision within 15 days after receiv-
ing the conclusions and recommendations. Such official
may not delegate the requirement to review and make a
final decision. The decision of that official shall imme-
diately be implemented. If that official fails to make a de-
cision within 15 days, or if the decision is not immediately
implemented, the conclusions and recommendations of the
panel shall be deemed to be the decision of the Food and
Drug Administration and shall be implemented imme-
diately. The failure of the Secretary to take action to im-
plement that decision immediately shall constitute final
agency action for purposes of judicial review.’’.
SEC. 14. EXPORT OF NEW DRUGS.
Section 801(e) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381(e) is amended—
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(1) in paragraph (1), by inserting after ‘‘under
this Act’’ the following: ‘‘or in violation of section
505 or section 351 of the Public Health Service
Act’’,
(2) in paragraph (1), by striking the last sen-
tence, and
(3) by amending paragraph (2) to read as fol-
lows:
‘‘(2) Paragraph (1) does not apply to the export of—
‘‘(A) any device—
‘‘(i) which does not comply with an appli-
cable requirement under section 514 or 515,
‘‘(ii) which under section 520(g) is exempt
from either such section, or
‘‘(iii) which is a banned device under sec-
tion 516, or
‘‘(B) any drug (including a biological product)
which does not comply with an applicable require-
ment under section 505 or 512 or section 351 of the
Public Health Service Act,
unless the device or drug is in compliance with the require-
ments of paragraph (1). In the case of a device or drug
for which an export notice is required under this para-
graph, the Secretary may prohibit the export of such de-
vice or drug if the Secretary determines that the possibil-
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ity of the reimportation of the device or drug into the
United States presents an imminent hazard to the public
health and safety of the United States and the only means
of limiting the hazard is to prohibit the export of the de-
vice or drug.’’.
SEC. 15. EXPORT OF CERTAIN UNAPPROVED PRODUCTS.
Section 802 (21 U.S.C. 382) is repealed.
Æ