I 
109TH CONGRESS 
2D SESSION 
H. R. 4792 
To fix the Medicare Part D prescription drug program by requiring the 
Secretary of Health and Human Services to negotiate fair prices for 
prescription drugs on behalf of Medicare beneficiaries, to further reduce 
drug costs to consumers by allowing the importation of prescription 
drugs under the Federal Food, Drug, and Cosmetic Act, to provide 
seniors with adequate time to consider their options under Medicare 
part D by extending the 2006 Medicare prescription drug enrollment 
period through December 31, 2006, without penalty, and for other pur-
poses. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 16, 2006 
Mr. LARSEN of Washington (for himself and Mr. MCDERMOTT) introduced the 
following bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committees on Ways and Means and Judi-
ciary, for a period to be subsequently determined by the Speaker, in each 
case for consideration of such provisions as fall within the jurisdiction of 
the committee concerned 
A BILL 
To fix the Medicare Part D prescription drug program by 
requiring the Secretary of Health and Human Services 
to negotiate fair prices for prescription drugs on behalf 
of Medicare beneficiaries, to further reduce drug costs 
to consumers by allowing the importation of prescription 
drugs under the Federal Food, Drug, and Cosmetic Act, 
to provide seniors with adequate time to consider their 
options under Medicare part D by extending the 2006 
Medicare prescription drug enrollment period through 
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December 31, 2006, without penalty, and for other pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Fix Medicare Part D 
Act’’. 
TITLE I—NEGOTIATION OF FAIR 
DRUG PRICES 
SEC. 101. NEGOTIATING FAIR PRICES FOR MEDICARE PRE-
SCRIPTION DRUGS ON BEHALF OF MEDICARE 
BENEFICIARIES. 
Section 1860D–11 of the Social Security Act (42 
U.S.C. 1395–111) is amended by striking subsection (i) 
(relating to noninterference) and by inserting the fol-
lowing: 
‘‘(i) REQUIREMENT TO NEGOTIATE PRICES WITH 
MANUFACTURERS.—In order to ensure that beneficiaries 
enrolled under prescription drug plans and MA–PD plans 
pay the lowest possible price, the Secretary shall have and 
exercise authority similar to that of the Secretary of Vet-
erans Affairs, Secretary of Defense, and the heads of other 
Federal agencies and departments that purchase prescrip-
tion drugs in bulk to negotiate contracts with manufactur-
ers of covered part D drugs, consistent with the require-
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ments and in furtherance of the goals of providing quality 
care and containing costs under this part.’’. 
TITLE II—DRUG IMPORTATION 
IMPROVEMENTS 
SEC. 201. SHORT TITLE. 
This title may be cited as the ‘‘Pharmaceutical Mar-
ket Access Act of 2006’’. 
SEC. 202. FINDINGS. 
Congress finds as follows: 
(1) Americans unjustly pay up to 1000 percent 
more to fill their prescriptions than consumers in 
other countries. 
(2) The United States is the world’s largest 
market for pharmaceuticals yet consumers still pay 
the world’s highest prices. 
(3) An unaffordable drug is neither safe nor ef-
fective. Allowing and structuring the importation of 
prescription drugs ensures access to affordable 
drugs, thus providing a level of safety to American 
consumers they do not currently enjoy. 
(4) According to the Congressional Budget Of-
fice, 
American 
seniors 
alone 
will 
spend 
$1,800,000,000,000 on pharmaceuticals over the 
next 10 years. 
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(5) Allowing open pharmaceutical markets 
could 
save 
American 
consumers 
at 
least 
$635,000,000,000 of their own money. 
SEC. 203. PURPOSES. 
The purposes of this title are as follows: 
(1) To give all Americans immediate relief from 
the outrageously high cost of pharmaceuticals. 
(2) To reverse the perverse economics of the 
American pharmaceutical market. 
(3) To allow the importation of prescription 
drugs only if the drugs and facilities where such 
drugs are manufactured are approved by the Food 
and Drug Administration, and to exclude pharma-
ceutical narcotics. 
(4) To require that imported prescription drugs 
be packaged and shipped using counterfeit-resistant 
technologies. 
SEC. 204. AMENDMENTS TO SECTION 804 OF THE FEDERAL 
FOOD, DRUG, AND COSMETIC ACT. 
(a) DEFINITIONS.—Section 804(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 384(a)) is 
amended to read as follows: 
‘‘(a) DEFINITIONS.—In this section: 
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‘‘(1) IMPORTER.—The term ‘importer’ means a 
pharmacy, group of pharmacies, pharmacist, or 
wholesaler. 
‘‘(2) PERMITTED
COUNTRY.—The term ‘per-
mitted country’ means a country, union, or economic 
area that is listed in subparagraph (A) of section 
802(b)(1) (as of December 31, 2003), except that 
the Secretary— 
‘‘(A) may add a country, union, or eco-
nomic area to such list for purposes of this sec-
tion if the Secretary determines that the coun-
try, union, or economic area has a pharma-
ceutical infrastructure that is substantially 
equivalent or superior to the pharmaceutical in-
frastructure of the United States, taking into 
consideration pharmacist qualifications, phar-
macy storage procedures, the drug distribution 
system, the drug dispensing system, and market 
regulation; and 
‘‘(B) may remove a country, union, or eco-
nomic area from such list for purposes of this 
section if the Secretary determines that the 
country, union, or economic area does not have 
such a pharmaceutical infrastructure. 
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‘‘(3) PHARMACIST.—The term ‘pharmacist’ 
means a person licensed by the relevant govern-
mental authority to practice pharmacy, including the 
dispensing and selling of prescription drugs. 
‘‘(4) PHARMACY.—The term ‘pharmacy’ means 
a person that is licensed by the relevant govern-
mental authority to engage in the business of selling 
prescription drugs that employs 1 or more phar-
macists. 
‘‘(5) PRESCRIPTION
DRUG.—The term ‘pre-
scription drug’ means a drug subject to section 
503(b), other than— 
‘‘(A) a controlled substance (as defined in 
section 102 of the Controlled Substances Act 
(21 U.S.C. 802)); 
‘‘(B) a biological product (as defined in 
section 351 of the Public Health Service Act 
(42 U.S.C. 262)); 
‘‘(C) an infused drug (including a peri-
toneal dialysis solution); 
‘‘(D) an intravenously injected drug; 
‘‘(E) a drug that is inhaled during surgery; 
or 
‘‘(F) a drug which is a parenteral drug, 
the importation of which pursuant to subsection 
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(b) is determined by the Secretary to pose a 
threat to the public health, in which case sec-
tion 801(d)(1) shall continue to apply. 
‘‘(6) QUALIFYING DRUG.—The term ‘qualifying 
drug’ means a prescription drug that— 
‘‘(A) is approved pursuant to an applica-
tion submitted under section 505(b)(1); and 
‘‘(B) is not— 
‘‘(i) a drug manufactured through 1 
or more biotechnology processes; 
‘‘(ii) a drug that is required to be re-
frigerated; or 
‘‘(iii) a photoreactive drug. 
‘‘(7) QUALIFYING INTERNET PHARMACY.—The 
term ‘qualifying Internet pharmacy’ means a reg-
istered exporter that dispenses qualifying drugs to 
individuals over an Internet website. 
‘‘(8) QUALIFYING
LABORATORY.—The term 
‘qualifying laboratory’ means a laboratory in the 
United States that has been approved by the Sec-
retary for the purposes of this section. 
‘‘(9) REGISTERED EXPORTER.—The term ‘reg-
istered exporter’ means a person that is in the busi-
ness of exporting a drug to persons in the United 
States (or that seeks to be in such business), for 
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which a registration under this section has been ap-
proved and is in effect. 
‘‘(10) WHOLESALER.— 
‘‘(A) IN GENERAL.—The term ‘wholesaler’ 
means a person licensed as a wholesaler or dis-
tributor of prescription drugs in the United 
States under section 503(e)(2)(A). 
‘‘(B) EXCLUSION.—The term ‘wholesaler’ 
does not include a person authorized to import 
drugs under section 801(d)(1).’’. 
(b) REGULATIONS.—Section 804(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 384(b)) is 
amended to read as follows: 
‘‘(b) REGULATIONS.—Not later than 180 days after 
the date of enactment of the Pharmaceutical Market Ac-
cess Act of 2006, the Secretary, after consultation with 
the United States Trade Representative and the Commis-
sioner of Customs, shall promulgate regulations permit-
ting pharmacists, pharmacies, and wholesalers to import 
qualifying drugs from permitted countries into the United 
States.’’. 
(c) LIMITATION.—Section 804(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 384(c)) is 
amended by striking ‘‘prescription drug’’ each place it ap-
pears and inserting ‘‘qualifying drug’’. 
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(d) 
INFORMATION
AND
RECORDS.—Section 
804(d)(1) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 384(d)(1)) is amended— 
(1) by striking subparagraph (G) and redesig-
nating subparagraphs (H) through (N) as subpara-
graphs (G) through (M), respectively; 
(2) in subparagraph (H) (as so redesignated), 
by striking ‘‘telephone number, and professional li-
cense number (if any)’’ and inserting ‘‘and telephone 
number’’; and 
(3) in subparagraph (L) (as so redesignated), 
by striking ‘‘(J) and (L)’’ and inserting ‘‘(I) and 
(K)’’. 
(e) TESTING.—Section 804(e) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 384(e)) is amended 
to read as follows: 
‘‘(e) TESTING.—The regulations under subsection (b) 
shall require that the testing described under subpara-
graphs (I) and (K) of subsection (d)(1) be conducted by 
the importer of the qualifying drug, unless the qualifying 
drug is subject to the requirements under section 505C 
for counterfeit-resistant technologies.’’. 
(f) REGISTRATION OF EXPORTERS; INSPECTIONS.— 
Section 804(f) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 384(f)) is amended to read as follows: 
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‘‘(f) REGISTRATION OF EXPORTERS; INSPECTIONS.— 
‘‘(1) IN GENERAL.—Any person that seeks to 
be a registered exporter (referred to in this sub-
section as the ‘registrant’) shall submit to the Sec-
retary a registration that includes the following: 
‘‘(A) The name of the registrant and iden-
tification of all places of business of the reg-
istrant that relate to qualifying drugs, including 
each warehouse or other facility owned or con-
trolled by, or operated for, the registrant; 
‘‘(B) An agreement by the registrant to— 
‘‘(i) make its places of business that 
relate to qualifying drugs (including ware-
houses and other facilities owned or con-
trolled by, or operated for, the exporter) 
and records available to the Secretary for 
on-site inspections, without prior notice, 
for the purpose of determining whether the 
registrant is in compliance with this Act’s 
requirements; 
‘‘(ii) export only qualifying drugs; 
‘‘(iii) export only to persons author-
ized to import the drugs; 
‘‘(iv) notify the Secretary of a recall 
or withdrawal of a qualifying drug distrib-
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uted in a permitted country to or from 
which the registrant has exported or im-
ported, or intends to export or import, to 
the United States; 
‘‘(v) monitor compliance with registra-
tion conditions and report any noncompli-
ance promptly; 
‘‘(vi) submit a compliance plan show-
ing how the registrant will correct viola-
tions, if any; and 
‘‘(vii) promptly notify the Secretary of 
changes in the registration information of 
the registrant. 
‘‘(2) NOTICE OF APPROVAL OR DISAPPROVAL.— 
‘‘(A) IN
GENERAL.—Not later than 90 
days after receiving a completed registration 
from a registrant, the Secretary shall— 
‘‘(i) notify such registrant of receipt 
of the registration; 
‘‘(ii) assign such registrant a registra-
tion number; and 
‘‘(iii) approve or disapprove the appli-
cation. 
‘‘(B) DISAPPROVAL OF APPLICATION.— 
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