722
‘‘(II) compare the number of 
shipments 
under 
the 
regulations 
under subsection (b) during the study 
period that are determined to be 
counterfeit, misbranded, or adulter-
ated, and compare that number with 
the number of shipments made during 
the study period within the United 
States that are determined to be 
counterfeit, misbranded, or adulter-
ated; and 
‘‘(III) consult with the Secretary, 
the United States Trade Representa-
tive, and the Commissioner of Patents 
and Trademarks to evaluate the effect 
of importations under the regulations 
under subsection (b) on trade and 
patent rights under Federal law. 
‘‘(B) REPORT.—Not later than 2 years 
after the effective date of the regulations under 
subsection (b), the Institute of Medicine shall 
submit to Congress a report describing the find-
ings of the study under subparagraph (A). 
‘‘(2) BY THE COMPTROLLER GENERAL.—
723
‘‘(A) STUDY.—The Comptroller General of 
the United States shall conduct a study to de-
termine the effect of this section on the price of 
prescription drugs sold to consumers at retail. 
‘‘(B) REPORT.—Not later than 18 months 
after the effective date of the regulations under 
subsection (b), the Comptroller General of the 
United States shall submit to Congress a report 
describing the findings of the study under sub-
paragraph (A). 
‘‘(m) CONSTRUCTION.—Nothing in this section limits 
the authority of the Secretary relating to the importation 
of prescription drugs, other than with respect to section 
801(d)(1) as provided in this section. 
‘‘(n) EFFECTIVENESS OF SECTION.—
‘‘(1) IN GENERAL.—If, after the date that is 1 
year after the effective date of the regulations under 
subsection (b) and before the date that is 18 months 
after the effective date, the Secretary submits to 
Congress a certification that, in the opinion of the 
Secretary, based on substantial evidence obtained 
after the effective date, the benefits of implementa-
tion of this section do not outweigh any detriment 
of implementation of this section, this section shall 
cease to be effective as of the date that is 30 days
724
after the date on which the Secretary submits the 
certification. 
‘‘(2) PROCEDURE.—The Secretary shall not 
submit a certification under paragraph (1) unless, 
after a hearing on the record under sections 556 and 
557 of title 5, United States Code, the Secretary—
‘‘(A)(i) determines that it is more likely 
than not that implementation of this section 
would result in an increase in the risk to the 
public health and safety; 
‘‘(ii) identifies specifically, in qualitative 
and quantitative terms, the nature of the in-
creased risk; 
‘‘(iii) identifies specifically the causes of 
the increased risk; and 
‘‘(iv)(I) considers whether any measures 
can be taken to avoid, reduce, or mitigate the 
increased risk; and 
‘‘(II) if the Secretary determines that any 
measures described in subclause (I) would re-
quire additional statutory authority, submits to 
Congress a report describing the legislation that 
would be required; 
‘‘(B) identifies specifically, in qualitative 
and quantitative terms, the benefits that would
725
result from implementation of this section (in-
cluding the benefit of reductions in the cost of 
covered products to consumers in the United 
States, allowing consumers to procure needed 
medication that consumers might not otherwise 
be able to procure without foregoing other ne-
cessities of life); and 
‘‘(C)(i) compares in specific terms the det-
riment identified under subparagraph (A) with 
the benefits identified under subparagraph (B); 
and 
‘‘(ii) determines that the benefits do not 
outweigh the detriment. 
‘‘(o) CONDITIONS.—This section shall become effec-
tive only if the Secretary of Health and Human Services 
certifies to the Congress that the implementation of this 
section will—
‘‘(1) pose no additional risk to the public’s 
health and safety, and 
‘‘(2) result in a significant reduction in the cost 
of covered products to the American consumer. 
‘‘(p) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated such sums as are nec-
essary to carry out this section.’’.
726
(b) 
CONFORMING
AMENDMENTS.—The 
Federal 
Food, Drug, and Cosmetic Act is amended—
(1) in section 301(aa) (21 U.S.C. 331(aa)), by 
striking ‘‘covered product in violation of section 
804’’ and inserting ‘‘prescription drug in violation of 
section 804’’; and 
(2) in section 303(a)(6) (21 U.S.C. 333(a)(6), 
by striking ‘‘covered product pursuant to section 
804(a)’’ and inserting ‘‘prescription drug under sec-
tion 804(b)’’.
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