I 
108TH CONGRESS 
1ST SESSION H. R. 2544
To improve the quality, availability, diversity, personal privacy, and innovation 
of health care in the United States. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 19, 2003
Mr. ROHRABACHER introduced the following bill; which was referred to the 
Committee on Ways and Means, and in addition to the Committees on 
Energy and Commerce, and the Judiciary, for a period to be subsequently 
determined by the Speaker, in each case for consideration of such provi-
sions as fall within the jurisdiction of the committee concerned 
A BILL 
To improve the quality, availability, diversity, personal 
privacy, and innovation of health care in the United States.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Medical Independence, Privacy, and Innovation Act of 
2003’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows:
Sec. 1. Short title; table of contents.
TITLE I—TAX-RELATED PROVISIONS 
Sec. 101. Findings. 
Sec. 102. Deduction of medical expenses for individuals. 
Sec. 103. Medical checking accounts. 
Sec. 104. Decrease in minimum annual deductibles under a high deductible 
health plan for purposes of Archer MSAs. 
TITLE II—MEDICAL PRIVACY 
Sec. 201. Findings. 
Sec. 202. Modification of regulations on privacy of individually identifiable 
health information. 
TITLE III—MODIFICATIONS REGARDING REGULATION OF DRUGS 
UNDER FEDERAL FOOD, DRUG, AND COSMETIC ACT 
Sec. 301. Definition of drug. 
Sec. 302. Striking of effectiveness requirement; modifications regarding patent 
listings, patent certifications, and thirty-month rule. 
Sec. 303. Granting of exclusive or partially exclusive licenses regarding inven-
tions made with Federal assistance. 
Sec. 304. Importation of certain drugs.
TITLE I—TAX-RELATED 
PROVISIONS 
SEC. 101. FINDINGS. 
The Congress finds the following: 
(1) Current law confers tax benefits for health 
insurance provided as an employee fringe benefit, 
but no similar tax benefit for health insurance pur-
chased by individuals thus creating an unfair bias 
toward employer provided medical insurance plans 
and an unfair discrimination against individuals who 
seek marketplace alternatives to health insurance. 
(2) Current law confers a tax benefits for third 
party payment of medical expenses but no similar 
tax benefits for direct individual payment of medical 
expenses. This has promoted employer-provided
third party payment systems and discouraged direct 
doctor-patient relationships. 
(3) The current tax treatment of medical ex-
penses has resulted in a greatly distorted market-
place in medical insurance where decreased opportu-
nities for private personal health insurance has re-
duced competition both for medical insurance and 
health care services. This has resulted in an in-
creased costs of both health insurance and health 
care services and fostered over use of low high pre-
mium health insurance plans. 
(4) The current tax treatment of medical ex-
penses has restricted the freedom of individuals to 
exercise direct control over their health care dollars. 
The exclusion from gross income for employer-pro-
vided health care with no corresponding tax benefit 
for health insurance and health care costs bourn by 
individuals represents a strong incentive toward em-
ployers group plans. 
(5) The tax codes preferment of employer-pro-
vided group plans has triggered a marketplace re-
sponse reflected in the significant increases in large 
health care delivery, and the creation of a relative 
few health care conglomerates in lieu of thousands 
of competitive providers of medical insurance and
‘‘(1) MEDICAL CHECKING ACCOUNT.—The term 
‘medical checking account’ means a trust created or 
organized in the United States for the exclusive ben-
efit of a qualified individual or his beneficiaries, but 
only if the written governing instrument creating the 
trust meets the following requirements: 
‘‘(A) Except in the case of a rollover con-
tribution described in paragraph (4)(C), no con-
tribution will be accepted unless it is in cash, or 
it exceeds $1,000 ($2,000 in the case of mar-
ried individuals filing a joint return, a surviving 
spouse, and a head of household). 
‘‘(B) The trustee is a bank (as defined in 
section 408(n), an insurance company (as de-
fined in section 816), or another person who 
demonstrates to the satisfaction of the Sec-
retary that the manner in which such person 
will administer the trust will be consistent with 
the requirements of this section. 
‘‘(C) No part of the trust assets will be in-
vested in life insurance contracts. 
‘‘(D) The assets of the trust will not be 
commingled with other property except in a 
common trust fund or common investment 
fund.
‘‘(E) The interest of an individual in the 
balance in his account is nonforfeitable. 
‘‘(2) QUALIFIED
MEDICAL
EXPENSES.—The 
term ‘qualified medical expenses’ means, with re-
spect to an account holder, amounts paid by such 
holder for medical care (as defined in section 213(d) 
for such individual, the spouse of such individual, 
and any dependent (as defined in section 152 of 
such individual, but only to the extent such amounts 
are not compensated for by insurance or otherwise 
(including distributions from an Archer MSA which 
are not includible in gross income by reason of sec-
tion 220(f)(1)). 
‘‘(3) CHANGE IN FILING STATUS.—In the case 
of a taxpayer whose filing status changes during the 
taxable year, the limitation under subparagraph (B) 
shall be apportioned among the filing statuses of the 
taxpayer in accordance with regulations prescribed 
by the Secretary. 
‘‘(4) CERTAIN RULES TO APPLY.—Rules similar 
to the following rules shall apply for purposes of this 
section: 
‘‘(A) Section 219(d)(2) (relating to no de-
duction for rollovers).
‘‘(B) Section 219(f)(3) (relating to time 
when contributions deemed made). 
‘‘(C) Section 219(f)(5) (relating to em-
ployer payments). 
‘‘(D) Section 220(f)(5) (relating to rollover 
contributions). 
‘‘(E) Section 220(f)(7) (relating to trans-
fer of account incident to divorce). 
‘‘(F) Section 220(f)(8) (relating to treat-
ment after death of account holder). 
‘‘(G) Section 408(g) (relating to commu-
nity property laws). 
‘‘(H) Section 408(h) (relating to custodial 
accounts). 
‘‘(e) TAX TREATMENT OF DISTRIBUTIONS.—
‘‘(1) AMOUNTS USED FOR QUALIFIED MEDICAL 
EXPENSES.—Any amount paid or distributed out of 
a medical checking account which is used exclusively 
to pay qualified medical expenses of any account 
holder shall not be includible in gross income.
‘‘(2) INCLUSION OF AMOUNTS NOT USED FOR 
QUALIFIED MEDICAL EXPENSES.—Any amount paid 
or distributed out of a medical checking account 
which is not used exclusively to pay the qualified
medical expenses of the account holder shall be in-
cluded in the gross income of such holder. 
‘‘(3) ADDITIONAL TAX ON DISTRIBUTIONS NOT 
USED
FOR
QUALIFIED
MEDICAL
EXPENSES.—For 
purposes of this section, rules similar to the rules of 
section 220(f)(4) shall apply. 
‘‘(4) COORDINATION WITH MEDICAL EXPENSE 
DEDUCTION.—For purposes of determining the 
amount of the deduction under section 213, any pay-
ment or distribution out of a medical checking ac-
count for qualified medical expenses shall not be 
treated as an expense paid for medical care. 
‘‘(f) REPORTS.—The Secretary may require the 
trustee of a medical checking account to make such re-
ports regarding such account to the Secretary and to the 
account holder with respect to contributions, distributions, 
and such other matters as the Secretary determines appro-
priate. The reports required by this subsection shall be 
filed at such time and in such manner and furnished to 
such individuals at such time and in such manner as may 
be required by the Secretary.’’. 
(b) TAX ON EXCESS CONTRIBUTIONS.—Section 4973 
of such Code (relating to tax on excess contributions to 
individual retirement accounts, certain section 403(b) con-
tracts, and certain individual retirement annuities) is 
amended—
(1) in subsection (a) by striking ‘‘or’’ at the end 
of paragraph (3), by inserting ‘‘or’’ at the end of 
paragraph (4), and by inserting after paragraph (4) 
the following: 
‘‘(5) a medical checking account (within the 
meaning of section 530A(d)),’’, and 
(2) by adding at the end the following new sub-
section: 
‘‘(g) EXCESS CONTRIBUTIONS TO MEDICAL CHECK-
ING ACCOUNTS.—For purposes of this section, in the case 
of medical checking accounts (within the meaning of sec-
tion 530A(d)), the term ‘excess contributions’ means the 
sum of—
‘‘(1) the aggregate amount contributed for the 
taxable year to the accounts (other than rollover 
contributions referred to in section 530A(d)(4)(C)) 
which is neither excludable from gross income under 
section 106(b) nor allowable as a deduction or credit 
under section 530A for such year, and 
‘‘(2) the amount determined under this sub-
section for the preceding taxable year, reduced by 
the sum of—
‘‘(A) the distributions out of the accounts 
which were included in gross income under sec-
tion 530A(e)(2), and 
‘‘(B) the excess (if any) of—
‘‘(i) the sum of the maximum amount 
allowable as a deduction or credit under 
section 530A (determined without regard 
to section 106(b)) for the taxable year, 
over 
‘‘(ii) the amount contributed to the 
accounts for the taxable year. 
For purposes of this subsection, any contribution which 
is distributed out of the medical savings account in a dis-
tribution to which section 530A(d)(4)(B) applies shall be 
treated as an amount not contributed.’’. 
(c) TAX ON PROHIBITED TRANSACTIONS.—
(1) Section 4975 of such Code (relating to tax 
on prohibited transactions) is amended by adding at 
the end of subsection (c) the following new para-
graph: 
‘‘(6) SPECIAL RULE FOR MEDICAL CHECKING 
ACCOUNTS.—An individual for whose benefit a med-
ical checking account (within the meaning of section 
530A(d)) is established shall be exempt from the tax 
imposed by this section with respect to any trans-
action concerning such account (which would other-
wise be taxable under this section) if, with respect 
to such transaction, the account ceases to be a med-
ical checking account by reason of the application of 
section 530A(e)(2) to such account.’’. 
(2) Paragraph (1) of section 4975(e) of such 
Code is amended by striking ‘‘or’’ at the end of sub-
paragraph (E), by redesignating subparagraph (F) 
as subparagraph (G), and by inserting after sub-
paragraph (E) the following new subparagraph: 
‘‘(F) a medical checking account described 
in section 530A(d), or’’. 
(d) FAILURE TO PROVIDE REPORTS ON MEDICAL 
CHECKING ACCOUNTS.—Paragraph (2) of section 6693(a) 
(relating to general rule on reports) is amended by strik-
ing ‘‘and’’ at the end of subparagraph (C), by striking the 
period at the end of subparagraph (D) and inserting ‘‘, 
and’’, and by inserting after subparagraph (D) the fol-
lowing new subparagraph: 
‘‘(E) section 530A(g) (relating to medical 
savings accounts).’’. 
(e) CLERICAL AMENDMENT.—The table of parts for 
subchapter F of chapter 1 of such Code is amended by 
adding at the end the following new item:
‘‘PART IX. MEDICAL CHECKING ACCOUNTS.’’.
(f) EFFECTIVE DATE.—The amendments made by 
this section shall apply to taxable years beginning after 
December 31, 2003. 
SEC. 104. DECREASE IN MINIMUM ANNUAL DEDUCTIBLES 
UNDER A HIGH DEDUCTIBLE HEALTH PLAN 
FOR PURPOSES OF ARCHER MSAS. 
(a) IN GENERAL.—Subparagraph (A) of section 
220(c)(2) of the Internal Revenue Code of 1986 (defining 
high deductible health plan) is amended—
(1) in clause (i) by striking ‘‘$1,500’’ and in-
serting ‘‘$1,000’’, and 
(2) in clause (ii) by striking ‘‘$3,000’’ and in-
serting ‘‘$2,000’’. 
(b) MINIMUM NOT INCREASED BY INFLATION.—Sec-
tion 220(g) of such Code is amended by inserting ‘‘(other 
than the $1,000 amount in subparagraph (A)(i) and the 
$2,000 amount in subparagraph (A)(ii) thereof)’’ after 
‘‘subsection (c)(2)’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to taxable years beginning after 
December 31, 2003.
TITLE II—MEDICAL PRIVACY 
SEC. 201. FINDINGS. 
The Congress finds the following:
(1) Medical privacy is an issue that concerns a 
growing number of people in the United States. The 
culture of the United States has always strongly fa-
vored a close physician-patient relationship. One of 
the key elements of this relationship is the trust that 
a patient has that their personal information will be 
treated as confidential by medical personnel and will 
not be made public or accessible to other persons 
without their permission. 
(2) In our increasingly complex times, two 
trends are combining to exert pressure on maintain-
ing the confidentiality of health care information. 
First, public policy favors an increased ability to 
provide protection against harmful prescription 
interactions and for the reporting of medications’ se-
rious side effects. Second, health care insurers desire 
to take advantage of economies of scale in control-
ling health care costs. These trends have greatly re-
duced expectations for the privacy of health care in-
formation. 
(3) For the first time in our Nation’s history, 
serious loopholes have been written into privacy pro-
tections that were created to protect the right of in-
dividuals. Positive changes in privacy law have been 
made in recent years to guarantee that patients are
notified regarding the use of their health informa-
tion, have access to their own medical records, and 
are able to request corrections of such records. 
These protections must be maintained and strength-
ened. 
(4) One of the greatest needs in the area of 
health privacy is to protect individuals against the 
use of their confidential health information for prof-
it-generating consumer marketing. Patients justifi-
ably have objections to this use of their information 
without their consent. 
(5) There recently have been implemented a se-
ries of alarming modifications to the standards pre-
viously finalized to protect the privacy of individually 
identifiable 
health 
information. 
These 
include 
changes in important definitions, additions to the 
category of health care operations for which patient 
consent for the use of their information is not re-
quired, and changes in permitted use of patient in-
formation without consent for public health pur-
poses. 
(6) Recent rollbacks in health privacy need to 
be reversed, and the individuals’ confidence that 
their private conversations with medical personnel 
will remain private needs to be strengthened.
(7) There is also a need to protect the integrity 
and confidentiality of social security account num-
bers and to prohibit Federal agencies from imposing 
national standards for identification of individuals. 
SEC. 202. MODIFICATION OF REGULATIONS ON PRIVACY OF 
INDIVIDUALLY IDENTIFIABLE HEALTH IN-
FORMATION. 
(a) MARKETING.—
(1) IN GENERAL.—The modifications made by 
the August 2002 medical privacy rule to the defini-
tion of the term ‘‘marketing’’ in section 164.501 of 
title 45, Code of Federal Regulations, shall have no 
force or effect. 
(2) AUTHORIZATIONS
FOR
MARKETING.—Sec-
tion 164.508 of title 45, Code of Federal Regula-
tions, shall be construed and applied so as to require 
that, if an authorization is required for a use or dis-
closure of protected health information for mar-
keting, the authorization shall be considered invalid 
unless it—
(A) uses the term ‘‘marketing’’; 
(B) states that the purpose of the use or 
disclosure involved is marketing; and 
(C) describes the specific marketing uses 
and disclosures authorized.
(b) CONSENT FOR USES OR DISCLOSURES TO CARRY 
OUT TREATMENT, PAYMENT, OR HEALTH CARE OPER-
ATIONS.—
(1) IN GENERAL.—The modifications made to 
section 164.506 of title 45, Code of Federal Regula-
tions, by the August 2002 medical privacy rule shall 
have no force or effect. 
(2) USE OR DISCLOSURE WITHOUT CONSENT.—
(A) IN GENERAL.—Section 164.506 of title 
45, Code of Federal Regulations, insofar as it 
permits any use or disclosure of protected 
health information without consent, shall have 
no force or effect. 
(B) CIRCUMSTANCES
WHERE
CONSENT 
NOT REQUIRED.—A health care provider may 
use or disclose an individual’s protected health 
information without obtaining the prior consent 
of the individual only in the following cir-
cumstances: 
(i) To fill or dispense a prescription, 
and to search for drug interactions related
to that prescription, if the health care pro-
vider obtains written consent from the in-
dividual as soon as practicable.
(ii) To carry out treatment of that in-
dividual if—
(I) the individual has not exe-
cuted a Universal Health Privacy 
Declaration promulgated under sub-
paragraph (C); 
(II) the individual and the health 
care provider have not had in-person 
communication regarding such treat-
ment; and 
(III) obtaining consent would be 
impracticable. 
(C) UNIVERSAL
HEALTH
PRIVACY
DEC-
LARATION.—
(i) IN
GENERAL.—The Secretary of 
Health and Human Services shall promul-
gate a document which shall be known as 
the ‘‘Universal Health Privacy Declara-
tion’’. 
(ii) 
ELIGIBILITY.—A 
Universal 
Health Privacy Declaration may be exe-
cuted by any individual who is a citizen of 
the United States or an alien lawfully ad-
mitted to the United States for permanent 
residence.
(iii) PURPOSE.—A Universal Health 
Privacy Declaration, once executed by an 
individual described in clause (ii) and not 
revoked, shall be considered to prohibit, as 
provided under subparagraph (B), a health 
care provider from using or disclosing the 
individual’s protected health information 
for treatment without obtaining the prior 
consent of the individual. 
(iv) ENFORCEMENT.—There is estab-
lished in the Department of Health and 
Human Services an Office of the Health 
Privacy Ombudsman, which shall be head-
ed by an individual known as the ‘‘Health 
Privacy Ombudsman’’. The Health Privacy 
Ombudsman shall be charged with inves-
tigating complaints submitted by individ-
uals described in clause (ii) regarding a 
use or disclosure of protected health infor-
mation in violation of their Universal 
Health Privacy Declaration. 
(c) DISCLOSURES
FOR LAW ENFORCEMENT PUR-
POSES.—Subparagraph (C) of section 164.506(f)(1)(ii) of 
title 45, Code of Federal Regulations shall have no force 
or effect.
(d) DEFINITIONS.—
(1) IN GENERAL.—For purposes of this section: 
(A) DECEMBER
2000
MEDICAL
PRIVACY 
RULE.—The term ‘‘December 2000 medical pri-
vacy rule’’ means the final rule on standards 
for privacy of individually identifiable health in-
formation published on December 28, 2000, in 
the Federal Register (65 Fed. Reg. 82462), in-
cluding the provisions of title 45, Code of Fed-
eral Regulations, revised or added by such rule. 
(B) 
AUGUST
2002
MEDICAL
PRIVACY 
RULE.—The term ‘‘August 2002 medical pri-
vacy rule’’ means the final rule, published on 
August 14, 2002, in the Federal Register (67 
Fed. Reg. 53182), that modified the December 
2000 medical privacy rule. 
(2) OTHER TERMS DEFINED.—For purposes of 
this section: 
(A) HEALTH CARE PROVIDER.—The term 
‘‘health care provider’’ shall have the meaning 
given such term in section 160.103 of title 45, 
Code of Federal Regulations, as contained in 
the December 2000 medical privacy rule. 
(B) DISCLOSURE; INDIVIDUAL; PROTECTED 
HEALTH
INFORMATION; TREATMENT; USE.—
The terms ‘‘disclosure’’, ‘‘individual’’, ‘‘pro-
tected health information’’, ‘‘treatment’’, and 
‘‘use’’ shall have the meaning given such terms 
in section 164.501 of title 45, Code of Federal 
Regulations, as contained in the December 
2000 medical privacy rule. 
TITLE III—MODIFICATIONS RE-
GARDING 
REGULATION 
OF 
DRUGS 
UNDER 
FEDERAL 
FOOD, DRUG, AND COSMETIC 
ACT 
SEC. 301. DEFINITION OF DRUG. 
Section 201(g)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(g)(1)) is amended in the 
first sentence by striking ‘‘and (B) articles intended’’ and 
all that follows and inserting the following: ‘‘and (B) arti-
cles intended for use in the diagnosis, cure, or treatment 
(but not mitigation or prevention) of disease in man or 
other animals.’’.
SEC. 302. STRIKING OF EFFECTIVENESS REQUIREMENT; 
MODIFICATIONS REGARDING PATENT LIST-
INGS, PATENT CERTIFICATIONS, AND THIRTY-
MONTH RULE. 
(a) STRIKING OF EFFECTIVENESS REQUIREMENT; 
PROHIBITION AGAINST LISTING OF CERTAIN PATENTS.—
(1) IN GENERAL.—Section 505(b) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)) is amended by striking ‘‘(b)(1)’’ and all that 
follows through ‘‘clinical trials required by clause 
(A).’’ and inserting the following: 
‘‘(b) APPLICATION.—
‘‘(1) CONTENTS.—
‘‘(A) IN GENERAL.—Any person may file 
with the Secretary an application with respect 
to any drug subject to the provisions of sub-
section (a). Such persons shall submit to the 
Secretary as a part of the application—
‘‘(i) full reports of investigations 
which have been made to show whether or 
not such drug is safe for use; 
‘‘(ii) a full list of the articles used as 
components of such drug; 
‘‘(iii) a full statement of the composi-
tion of such drug; 
‘‘(iv) a full description of the methods 
used in, and the facilities and controls 
used for, the manufacture, processing, and 
packing of such drug;
‘‘(v) such samples of such drug and of 
the articles used as components thereof as 
the Secretary may require; and 
‘‘(vi) specimens of the labeling pro-
posed to be used for such drug. 
‘‘(B) PATENT INFORMATION.—
‘‘(i) REQUIREMENT.—The applicant 
shall file with the application the patent 
number and the expiration date of any pat-
ent which claims the drug for which the 
applicant submitted the application or 
which claims a method of using such drug 
and with respect to which a claim of patent 
infringement could reasonably be asserted 
if a person not licensed by the owner en-
gaged in the manufacture use, or sale of 
the drug. 
‘‘(ii) TYPES OF PATENTS.—
‘‘(I) PATENTS SUBJECT TO RE-
QUIREMENT.—The patents for which 
information under clause (i) is re-
quired to be filed with the Secretary 
are drug substance (ingredient) pat-
ents, drug product (formulation and 
composition) patents, product by proc-
ess patents, and method of use pat-
ents. 
‘‘(II) PROHIBITION
REGARDING 
CERTAIN PATENTS.—Process patents, 
patents claiming packaging, patents 
claiming metabolites, and patents 
claiming intermediates are not patents 
described in subclause (I), and infor-
mation on such patents may not be 
filed with the Secretary. 
‘‘(III) PATENT REGARDING DRUG 
SUBSTANCE.—For patents that claim 
the drug substance, the applicant 
shall submit information only on pat-
ents that claim the drug substance 
that is the subject of the pending or 
approved application or that claim a 
drug substance that is the same as 
the active ingredient that is the sub-
ject of an approved or pending appli-
cation within the meaning of sub-
section (j)(2)(A)(ii). 
‘‘(IV) PATENT REGARDING DRUG 
PRODUCT.—For patents that claim a 
drug product, the applicant shall sub-
mit information only on those patents 
that claim a drug product that is the 
subject of a pending or approved ap-
plication. 
‘‘(V) PATENT REGARDING METH-
OD OF USE.—For patents that claim a 
method of use, the applicant shall 
submit information only on those pat-
ents that claim indications or other 
conditions of use that are the subject 
of a pending or approved application. 
For approved applications, the appli-
cant shall identify the indication or 
other condition of use in the approved 
labeling that corresponds to the listed 
patent and claim identified. 
‘‘(iii) FILING OF PATENT AFTER SUB-
MISSION OF APPLICATION.—If an applica-
tion is filed under this subsection for a 
drug and a patent which claims such drug
or a method of using such drug is issued 
after the filing date but before approval of 
the application, the applicant shall amend 
the application to include the information 
required by clauses (i) and (ii).
‘‘(iv) PUBLICATION
OF
PATENT
IN-
FORMATION.—Upon approval of the appli-
cation, the Secretary shall publish informa-
tion submitted under clauses (i) through 
(iii). 
‘‘(C) GUIDANCE REGARDING INCLUSION OF 
WOMEN
AND
MINORITIES
IN
CLINICAL 
TRIALS.—The Secretary shall, in consultation 
with the Director of the National Institutes of 
Health and with representatives of the drug 
manufacturing industry, review and develop 
guidance, as appropriate, on the inclusion of 
women and minorities in clinical trials required 
by subparagraph (A)(i).’’. 
(2) CONFORMING AMENDMENTS.—The Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.) is amended—
(A) in section 201(p)—
(i) by striking ‘‘safety and effective-
ness of’’ and inserting ‘‘safety of’’; and 
(ii) by striking ‘‘safe and effective for 
use’’ and inserting ‘‘safe for use’’; and 
(B) in section 505—
(i) by striking ‘‘safety and effective-
ness’’ each place such term appears and 
inserting ‘‘safety’’; 
(ii) by striking ‘‘safety or effective-
ness’’ each place such term appears and 
inserting ‘‘safety’’; and 
(iii) in subsection (i)(1)(D), by strik-
ing ‘‘pediatric safety and efficacy’’ and in-
serting ‘‘pediatric safety’’. 
(b) ABBREVIATED APPLICATIONS; SINGLE CERTIFI-
CATION
REGARDING
PATENT
INVALIDITY
OR
NON-
INFRINGEMENT; SINGLE THIRTY-MONTH DELAY IN AP-
PROVAL.—Section 505(j)(2)(A) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(A)) is 
amended in the matter after and below clause (viii) by 
adding at the end the following sentence: ‘‘With respect 
to a certification under clause (vii)(IV), an abbreviated ap-
plication (whether or not amended) may not contain more 
than one such certification, without regard to patents filed 
after the date of the certification.’’. 
SEC. 303. GRANTING OF EXCLUSIVE OR PARTIALLY EXCLU-
SIVE 
LICENSES 
REGARDING 
INVENTIONS 
MADE WITH FEDERAL ASSISTANCE. 
No grant of an exclusive or partially exclusive license 
pursuant to chapter 18 of title 35, United States Code,
may be made, except in accordance with section 209 of 
such title (relating to the availability to the public of an 
invention and its benefits on reasonable terms). 
SEC. 304. IMPORTATION OF CERTAIN DRUGS. 
Chapter VIII of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381 et seq.) is amended by striking 
section 804 and inserting the following: 
‘‘IMPORTATION OF CERTAIN DRUGS 
‘‘SEC. 804. (a) REGULATIONS.—The Secretary, after 
consultation with the United States Trade Representative 
and the Commissioner of Customs, shall promulgate regu-
lations permitting pharmacists and wholesalers to import 
prescription drugs from foreign nations. 
‘‘(b) LIMITATION.—The regulations under subsection 
(a) shall require that safeguards be in place to ensure that 
each prescription drug imported under the regulations 
complies with section 505 (including being safe for the in-
tended use of the prescription drug) with sections 501 and 
502 and with other applicable requirements of this Act.’’.
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