109th CONGRESS
1st Session
H. R. 2599
To improve the quality, availability, diversity, personal privacy,
and innovation of health care in the United States.
IN THE HOUSE OF REPRESENTATIVES
May 24, 2005
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 Judiciary, 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 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 Representatives 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 2005'.
(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. 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 health savings accounts and Archer MSAs.
TITLE II--MEDICAL PRIVACY
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
inventions 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
purchased 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 expenses has resulted in a greatly
distorted marketplace in medical insurance where decreased opportunities
for private personal health insurance has reduced competition both for medical
insurance and health care services. This has resulted in an increased costs
of both health insurance and health care services and fostered over use
of low high premium health insurance plans.
(4) The current tax treatment of medical expenses has restricted the freedom
of individuals to exercise direct control over their health care dollars.
The exclusion from gross income for employer-provided health care with no
corresponding tax benefit for health insurance and health care costs bourn
by individuals represents a strong incentive toward employers group plans.
(5) The tax code's preferment of employer-provided group plans has triggered
a marketplace response 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 services.
This has increasingly placed medical decisions in the hands of health care
bureaucracies and has eroded doctor-patient relationships.
(6) The role of the marketplace in both medical insurance and medical services
should be strengthened. The discriminatory tax policies in the area of health
insurance and health care should be ended. Private individuals should be
able to contract for their health insurance and health care delivery in
atmosphere free of discriminatory tax pressures. High deductible low premium
as well as catastrophic alternatives in health insurance should be viable
options for all Americans.
SEC. 102. DEDUCTION OF MEDICAL EXPENSES FOR INDIVIDUALS.
(a) In General- Subsection (a) of section 213 of the Internal Revenue Code
of 1986 (relating to treatment of medical, dental, etc., expenses) is amended
to read as follows:
`(a) Allowance of Deduction- There shall be allowed as a deduction the expenses
paid during the taxable year, not compensated for by insurance or otherwise,
for medical care of the taxpayer, his spouse, or a dependent (as defined by
section 152, determined without regard to subsections (b)(1), (b)(2), and
(d)(1)(B) thereof).'.
(b) Deduction Allowed in Computing Adjusted Gross Income- Subsection (a) of
section 62 of such Code is amended by redesignating paragraph (19) (relating
to costs involving discrimination suits, etc.) as paragraph (20) and by inserting
after paragraph (20) the following new paragraph:
`(21) MEDICAL CARE- The deduction allowed by section 213.'.
(c) Conforming Amendments-
(1) Section 56(b)(1) of such Code is amended by striking subparagraph (B).
(2) Section 67(b) of such Code is amended by striking paragraph (5).
(3) Section 72(t)(2)(B) of such Code is amended by striking `to the extent
such distributions do not exceed the amount' and inserting `which are'.
(4) Sections 104(a) and 105(b) of such Code are both amended by striking
`(and not in excess of)'.
(d) Effective Date- The amendments made by this section shall apply to taxable
years beginning after December 31, 2005.
SEC. 103. MEDICAL CHECKING ACCOUNTS.
(a) In General- Subchapter F of chapter 1 of the Internal Revenue Code of
1986 (relating to exempt organizations) is amended by adding at the end the
following:
`PART IX--MEDICAL CHECKING ACCOUNTS
`Sec. 530A. Medical checking accounts.
`SEC. 530A. MEDICAL CHECKING ACCOUNTS.
`(a) General Rule- A medical checking account shall be exempt from taxation
under this subtitle. Notwithstanding the preceding sentence, any medical checking
account shall be subject to the taxes imposed by section 511 (relating to
imposition of tax on unrelated business income of charitable, etc., organizations).
Rules similar to the rules of paragraphs (2) and (4) of section 408(e) shall
apply to medical checking accounts, and any amount treated as distributed
under such rules shall be treated as not used to pay qualified medical expenses.
`(b) Deduction for Contributions-
`(1) IN GENERAL- In the case of an individual, there shall be allowed as
a deduction an amount equal to the aggregate amount paid in cash during
the taxable year to a medical checking account of the taxpayer.
`(A) MAXIMUM ANNUAL CONTRIBUTION- The deduction under paragraph (1) for
a taxable year shall not exceed $1,000 ($2,000 in the case of a joint
return).
`(B) MAXIMUM ALLOWABLE DEDUCTION BASED ON BALANCE IN ACCOUNT- No deduction
shall be allowed for a taxable year for any amount contributed to a medical
checking account if the sum of such amount plus the balance in the account
determined as of the end of the taxable year would exceed $2,000 ($4,000
in the case of married individuals filing a joint return, a surviving
spouse, and a head of household).
`(c) Credit for Contributions-
`(1) IN GENERAL- In the case of an individual, there shall be allowed as
a credit against the tax imposed by this chapter for the taxable year an
amount equal to the credit amount with respect to contributions made during
the taxable year to the medical checking account of the taxpayer.
`(2) CREDIT AMOUNT- For purposes of paragraph (1), the credit amount is
the lesser of--
`(A) the total amount of contributions to the medical checking account
for the taxable year reduced by the amount of contributions allowed as
a deduction under subsection (b), and
`(d) Definitions and Special Rules- For purposes of this section--
`(1) MEDICAL CHECKING ACCOUNT- The term `medical checking account' means
a trust created or organized in the United States for the exclusive benefit
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 contribution described in paragraph
(4)(D), no contribution will be accepted unless it is in cash, or it exceeds
$1,000 ($2,000 in the case of married 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 defined in section 816), or another person who demonstrates
to the satisfaction of the Secretary 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 invested 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 respect 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, determined without
regard to subsections (b)(1), (b)(2), and (d)(1)(B) thereof) 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 section 220(f)(1) or from a health savings
account which are not includible in gross income by reason of section 223(f)(1)).
`(3) CHANGE IN FILING STATUS- In the case of a taxpayer whose filing status
changes during the taxable year, the limitation under paragraph (1)(A) 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 deduction for rollovers).
`(B) Section 219(f)(3) (relating to time when contributions deemed made).
`(C) Section 219(f)(5) (relating to employer payments).
`(D) Section 220(f)(5) (relating to rollover contributions).
`(E) Section 220(f)(7) (relating to transfer of account incident to divorce).
`(F) Section 220(f)(8) (relating to treatment after death of account holder).
`(G) Section 408(g) (relating to community 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 included 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 payment or distribution
out of a medical checking account 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 reports regarding such account to the Secretary and to
the account holder with respect to contributions, distributions, and such
other matters as the Secretary determines appropriate. 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) contracts, and certain individual retirement annuities) is amended--
(1) in subsection (a) by striking `or' at the end of paragraph (4), by inserting
`or' at the end of paragraph (5), and by inserting after paragraph (5) the
following:
`(6) a medical checking account (within the meaning of section 530A(d)),',
and
(2) by adding at the end the following new subsection:
`(h) Excess Contributions to Medical Checking Accounts- For purposes of this
section, in the case of medical checking accounts (within the meaning of section
530A(d)), the term `excess contributions' means the sum of--
`(1) the aggregate amount contributed for the taxable year to such accounts
(other than rollover contributions referred to in section 530A(d)(4)(D))
which is not allowable as a deduction or credit under section 530A for such
year, and
`(2) the amount determined under this subsection for the preceding taxable
year, reduced by the sum of--
`(A) the distributions out of the accounts which were included in gross
income under section 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 for the taxable year, over
`(ii) the amount contributed to such accounts for the taxable year.
For purposes of this subsection, any contribution which is distributed out
of the medical checking account in a distribution to which section 530A(d)(4)(B)
applies shall be treated as an amount not contributed.'.
(c) Tax on Prohibited Transactions-
(1) Subsection (c) of section 4975 of such Code (relating to tax on prohibited
transactions) is amended by adding at the end the following new paragraph:
`(6) SPECIAL RULE FOR MEDICAL CHECKING ACCOUNTS- An individual for whose
benefit a medical 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 transaction concerning such account (which would otherwise
be taxable under this section) if, with respect to such transaction, the
account ceases to be a medical 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 subparagraph (F), by redesignating subparagraph (G) as
subparagraph (H), and by inserting after subparagraph (F) the following
new subparagraph:
`(G) 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) of such Code (relating to general rule on reports) is amended
by striking `and' at the end of subparagraph (D), by striking the period at
the end of subparagraph (E) and inserting `, and', and by inserting after
subparagraph (E) the following new subparagraph:
`(F) 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, 2005.
SEC. 104. DECREASE IN MINIMUM ANNUAL DEDUCTIBLES UNDER A HIGH DEDUCTIBLE
HEALTH PLAN FOR PURPOSES OF HEALTH SAVINGS ACCOUNTS AND ARCHER MSAS.
(a) Annual Deductible and Out-of-Pocket Expenses With Respect to Health Savings
Accounts-
(1) IN GENERAL- Subclause (I) of section 223(c)(2)(A) (ii) of the Internal
Revenue Code of 1986 (defining high deductible health plan) is amended by
striking `$5,000' and inserting `$4,000'.
(2) MINIMUM DEDUCTIBLE DECREASED; AMOUNTS NOT INCREASED BY INFLATION- Paragraph
(1) of section 223(g) of such Code is amended--
(A) in the matter preceding subparagraph (A) by striking `subsections
(b)(2) and (c)(2)(A)' and inserting `subsection (b)(2)', and
(B) in subparagraph (B) by striking `substituting' and all that follows
and inserting `substituting calendar year 1997 for `calendar year 1992'
in subparagraph (B) thereof.'.
(1) DECREASE IN MINIMUM DEDUCTIBLE- Subparagraph (A) of section 220(c)(2)
of the Internal Revenue Code of 1986 (defining high deductible health plan)
is amended--
(A) in clause (i) by striking `$1,500' and inserting `$1,000', and
(B) in clause (ii) by striking `$3,000' and inserting `$2,000'.
(2) MINIMUM NOT INCREASED BY INFLATION- Section 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, 2005.
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
favored 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 maintaining 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'
serious side effects. Second, health care insurers desire to take advantage
of economies of scale in controlling health care costs. These trends have
greatly reduced expectations for the privacy of health care information.
(3) For the first time in our Nation's history, serious loopholes have been
written into privacy protections that were created to protect the right
of individuals. Positive changes in privacy law have been made in recent
years to guarantee that patients are notified regarding the use of their
health information, have access to their own medical records, and are able
to request corrections of such records. These protections must be maintained
and strengthened.
(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
profit-generating consumer marketing. Patients justifiably have objections
to this use of their information without their consent.
(5) There recently have been implemented a series of alarming modifications
to the standards previously 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 required, and changes in permitted
use of patient information without consent for public health purposes.
(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 numbers and to prohibit Federal agencies from imposing
national standards for identification of individuals.
SEC. 202. MODIFICATION OF REGULATIONS ON PRIVACY OF INDIVIDUALLY IDENTIFIABLE
HEALTH INFORMATION.
(1) IN GENERAL- The modifications made by the August 2002 medical privacy
rule to the definition 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- Section 164.508 of title 45, Code of Federal
Regulations, shall be construed and applied so as to require that, if an
authorization is required for a use or disclosure of protected health information
for marketing, 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 Operations-
(1) IN GENERAL- The modifications made to section 164.506 of title 45, Code
of Federal Regulations, 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 circumstances:
(i) To fill or dispense a prescription, and to search for drug interactions
related to that prescription, if the health care provider obtains written
consent from the individual as soon as practicable.
(ii) To carry out treatment of that individual if--
(I) the individual has not executed a Universal Health Privacy Declaration
promulgated under subparagraph (C);
(II) the individual and the health care provider have not had in-person
communication regarding such treatment; and
(III) obtaining consent would be impracticable.
(C) UNIVERSAL HEALTH PRIVACY DECLARATION-
(i) IN GENERAL- The Secretary of Health and Human Services shall promulgate
a document which shall be known as the `Universal Health Privacy Declaration'.
(ii) ELIGIBILITY- A Universal Health Privacy Declaration may be executed
by any individual who is a citizen of the United States or an alien
lawfully admitted 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 established in the Department of Health and
Human Services an Office of the Health Privacy Ombudsman, which shall
be headed by an individual known as the `Health Privacy Ombudsman'.
The Health Privacy Ombudsman shall be charged with investigating complaints
submitted by individuals described in clause (ii) regarding a use or
disclosure of protected health information in violation of their Universal
Health Privacy Declaration.
(c) Disclosures for Law Enforcement Purposes- Subparagraph (C) of section
164.506(f)(1)(ii) of title 45, Code of Federal Regulations shall have no force
or effect.
(1) IN GENERAL- For purposes of this section:
(A) DECEMBER 2000 MEDICAL PRIVACY RULE- The term `December 2000 medical
privacy rule' means the final rule on standards for privacy of individually
identifiable health information published on December 28, 2000, in the
Federal Register (65 Fed. Reg. 82462), including the provisions of title
45, Code of Federal Regulations, revised or added by such rule.
(B) AUGUST 2002 MEDICAL PRIVACY RULE- The term `August 2002 medical privacy
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', `protected 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 REGARDING 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) articles 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 LISTINGS, 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 Federal 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:
`(A) IN GENERAL- Any person may file with the Secretary an application
with respect to any drug subject to the provisions of subsection (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 composition 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 proposed to be used for such drug.
`(i) REQUIREMENT- The applicant shall file with the application the
patent number and the expiration date of any patent 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 engaged in the manufacture use, or sale of the drug.
`(I) PATENTS SUBJECT TO REQUIREMENT- The patents for which information
under clause (i) is required to be filed with the Secretary are drug
substance (ingredient) patents, drug product (formulation and composition)
patents, product by process patents, and method of use patents.
`(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 information
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 patents
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 subject of an approved or pending
application within the meaning of subsection (j)(2)(A)(ii).
`(IV) PATENT REGARDING DRUG PRODUCT- For patents that claim a drug
product, the applicant shall submit information only on those patents
that claim a drug product that is the subject of a pending or approved
application.
`(V) PATENT REGARDING METHOD OF USE- For patents that claim a method
of use, the applicant shall submit information only on those patents
that claim indications or other conditions of use that are the subject
of a pending or approved application. For approved applications, the
applicant 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 SUBMISSION OF APPLICATION- If an application
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 INFORMATION- Upon approval of the application,
the Secretary shall publish information 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--
(i) by striking `safety and effectiveness of' and inserting `safety
of'; and
(ii) by striking `safe and effective for use' and inserting `safe for
use'; and
(i) by striking `safety and effectiveness' each place such term appears
and inserting `safety';
(ii) by striking `safety or effectiveness' each place such term appears
and inserting `safety'; and
(iii) in subsection (i)(1)(D), by striking `pediatric safety and efficacy'
and inserting `pediatric safety'.
(b) Abbreviated Applications; Amendments Regarding Thirty-Month Delay in Approval-
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))
is amended--
(1) in subsection (c)(3)--
(A) in subparagraph (C), in the matter preceding clause (i), by striking
`thirty-month period' and inserting `twenty-month period'; and
(B) in subparagraph (E)(ii), by striking `thirty-month period' and inserting
`twenty-month period'; and
(2) in subsection (j)(5)--
(A) in subparagraph (B)(iii), in the matter preceding subclause (I), by
striking `thirty-month period' and inserting `twenty-month period'; and
(B) in subparagraph (F)(ii), by striking `thirty-month period' and inserting
`twenty-month period'.
SEC. 303. GRANTING OF EXCLUSIVE OR PARTIALLY EXCLUSIVE 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 Cosmetic 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
regulations 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 intended use of the
prescription drug) with sections 501 and 502 and with other applicable requirements
of this Act.'.
END
