[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2182 Introduced in House (IH)]
112th CONGRESS
1st Session
H. R. 2182
To provide incentives for the development of qualified infectious
disease products.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 15, 2011
Mr. Gingrey of Georgia (for himself, Mr. Gene Green of Texas, Mr.
Whitfield, Ms. DeGette, Mr. Rogers of Michigan, Ms. Eshoo, and Mr.
Shimkus) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To provide incentives for the development of qualified infectious
disease products.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Generating Antibiotic Incentives Now
Act of 2011''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Extension of exclusivity period for drugs.
Sec. 4. Additional extension of exclusivity period for qualified
infectious disease products for which a
companion diagnostic test is cleared or
approved.
Sec. 5. Priority review.
Sec. 6. Fast track product.
Sec. 7. Study on incentives for qualified infectious disease biological
products.
Sec. 8. Clinical trials.
SEC. 3. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS.
(a) In General.--The Federal Food, Drug, and Cosmetic Act is
amended by inserting after section 505D (21 U.S.C. 355e) the following:
``SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW QUALIFIED
INFECTIOUS DISEASE PRODUCTS.
``(a) Extension.--If, prior to approval of a drug pursuant to an
application submitted under section 505(b), the Secretary determines
that the drug is a qualified infectious disease product, then the four-
and five-year periods described in subsections (c)(3)(E)(ii) and
(j)(5)(F)(ii) of section 505, the three-year periods described in
clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and
(iv) of subsection (j)(5)(F) of section 505, or the seven-year period
described in section 527, as applicable, shall be extended by five
years.
``(b) Relation to Pediatric Exclusivity.--Any extension under
subsection (a) of a period shall be in addition to any extension of the
period under section 505A with respect to the drug.
``(c) Limitations.--Subsection (a) does not apply to the approval
of--
``(1) a supplement to an application under section 505(b)
for any qualified infectious disease product for which an
extension described in subsection (a) is in effect or has
expired; or
``(2) a subsequent application filed by the same sponsor or
manufacturer of a qualified infectious disease product
described in paragraph (1) (or a licensor, predecessor in
interest, or other related entity) for--
``(A) a change (not including a modification to the
structure of the qualified infectious disease product)
that results in a new indication, route of
administration, dosing schedule, dosage form, delivery
system, delivery device, or strength; or
``(B) a modification to the structure of the
qualified infectious disease product that does not
result in a change in safety or effectiveness.
``(d) Determination.--The manufacturer or sponsor of a drug may
request the Secretary to designate a drug as a qualified infectious
disease product. Such a request for designation shall be made at least
45 days before the submission of an application under section 505(b)
for such drug. The Secretary shall, not later than 30 days after the
submission of such request, determine whether the drug is a qualified
infectious disease product.
``(e) Regulations.--The Secretary shall promulgate regulations for
carrying out this section. The Secretary shall promulgate the initial
regulations for carrying out this section not later than 12 months
after the date of the enactment of this section.
``(f) Definitions.--In this section:
``(1) Qualified infectious disease product.--The term
`qualified infectious disease product' means an antibiotic drug
for treating, detecting, preventing, or identifying a
qualifying pathogen.
``(2) Qualifying pathogen.--The term `qualifying pathogen'
means--
``(A) resistant gram positive pathogens, including
methicillin-resistant Staphylococcus aureus (MRSA),
vancomycin-resistant Staphylococcus aureus (VRSA), and
vancomycin-resistant enterococcus (VRE);
``(B) multi-drug resistant gram negative bacteria,
including Acinetobacter, Klebsiella, Pseudomonas, and
E. coli species;
``(C) multi-drug resistant tuberculosis; or
``(D) any other infectious pathogen identified for
purposes of this section by the Secretary.''.
(b) Application.--Section 505E of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), applies only with respect to
a drug that is first approved under section 505(c) of such Act (21
U.S.C. 355(c)) on or after the date of the enactment of this Act.
SEC. 4. ADDITIONAL EXTENSION OF EXCLUSIVITY PERIOD FOR QUALIFIED
INFECTIOUS DISEASE PRODUCTS FOR WHICH A COMPANION
DIAGNOSTIC TEST IS CLEARED OR APPROVED.
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.),
as amended by section 3, is further amended by inserting after section
505E the following:
``SEC. 505E-1. ADDITIONAL EXTENSION OF EXCLUSIVITY FOR QUALIFIED
INFECTIOUS DISEASE PRODUCTS FOR WHICH A COMPANION
DIAGNOSTIC TEST IS CLEARED OR APPROVED.
``(a) In General.--If the sponsor or manufacturer of a qualified
infectious disease product identifies in accordance with subsection (b)
a companion diagnostic test described in subsection (c), any period
extended under section 505E(a) with respect to such product shall be
further extended by 6 months.
``(b) Identification Requirements.--For purposes of subsection (a),
the identification of a companion diagnostic test shall--
``(1) be made in such manner as the Secretary may require;
and
``(2) occur before the expiration of the period to be
extended under subsection (a), not counting any extension to
such period under section 505E(a) or 505A.
``(c) Companion Diagnostic Test.--For purposes of subsection (a), a
device is a companion diagnostic test with respect to a qualified
infectious disease product if each of the following is met:
``(1) The device is determined by the Secretary under
subsection (f) to be a test for diagnosis of a qualifying
pathogen.
``(2) The qualified infectious disease product has been
determined under section 505E(d) to be for treating, detecting,
preventing, or identifying such qualifying pathogen.
``(3) The device is cleared under section 510(k) or
approved under section 515.
``(4) The sponsor or manufacturer, as applicable, of the
qualified infectious disease product has the exclusive rights
to submit an identification under subsection (a) with respect
to the device.
``(d) Relation to Pediatric Exclusivity.--Any extension under
subsection (a) of a period with respect to a qualified infectious
disease product shall be in addition to any extension of the period
under section 505A of this Act with respect to the product.
``(e) Limitations.--After the extension of any period under
subsection (a) with respect to a qualified infectious disease product
pursuant to the identification of a device as a companion diagnostic
test, subsection (a) does not authorize--
``(1) any subsequent extension with respect to such
product; or
``(2) any extension with respect to any other product
pursuant to identification of such device.
``(f) Determination.--The sponsor or manufacturer of a drug may
request the Secretary to determine that a device is a test for
diagnosis of a qualifying pathogen. Such a request shall be made at
least 45 days before the submission of a notification under section
510(k) or an application under section 515 for such device. The
Secretary shall, not later than 30 days after the submission of such
request, determine whether the device is a test for diagnosis of a
qualifying pathogen.
``(g) Definitions.--In this section:
``(1) The term `qualified infectious disease product' means
a drug that is determined to be a qualified infectious disease
product under section 505E.
``(2) The term `qualifying pathogen' has the meaning given
to such term in section 505E.''.
SEC. 5. PRIORITY REVIEW.
(a) Amendment.--Chapter V of the Federal Food, Drug, and Cosmetic
Act is amended by inserting after section 524 (21 U.S.C. 360n) the
following:
``SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS.
``(a) In General.--If the Secretary makes a determination under
section 505E(c) that a drug is a qualified infectious disease product,
then the Secretary shall give priority review to any application
submitted for approval for such drug under section 505(b).
``(b) Definition.--In this section, the term `priority review',
with respect to an application described in subsection (a), means
review and action by the Secretary on such application not later than 6
months after receipt by the Secretary of such application.''.
(b) Application.--Section 524A of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), applies only with respect to
an application that is submitted under section 505(b) (21 U.S.C.
355(b)) on or after the date of the enactment of this Act.
SEC. 6. FAST TRACK PRODUCT.
Paragraph (1) of section 506(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356(a)) is amended by inserting after ``if it
is intended for the treatment of a serious or life-threatening
condition and it demonstrates the potential to address unmet medical
needs for such a condition'' the following: ``or if the Secretary
determines under section 505E that the drug is a qualified infectious
disease product''.
SEC. 7. STUDY ON INCENTIVES FOR QUALIFIED INFECTIOUS DISEASE BIOLOGICAL
PRODUCTS.
(a) In General.--The Comptroller General of the United States
shall--
(1) conduct a study on the need for incentives to encourage
the research, development, and marketing of qualified
infectious disease biological products; and
(2) not later than 1 year after the date of the enactment
of this Act, submit a report to the Congress on the results of
such study, including any recommendations of the Comptroller
General on appropriate incentives for addressing such need.
(b) Definitions.--In this section:
(1) The term ``biological product'' has the meaning given
to such term in section 351 of the Public Health Service Act
(42 U.S.C. 262).
(2) The term ``qualified infectious disease biological
product'' means a biological product for treating, detecting,
preventing, or identifying a qualifying pathogen.
(3) The term ``qualifying pathogen'' has the meaning given
to such term in section 505E of the Federal Food, Drug, and
Cosmetic Act, as added by section 3 of this Act.
SEC. 8. CLINICAL TRIALS.
(a) Review and Revision of Guidelines.--
(1) In general.--Not later than 1 year after the date of
the enactment of this Act, and not later than 4 years
thereafter, the Secretary shall--
(A) review the guidelines of the Food and Drug
Administration for the conduct of clinical trials with
respect to antibiotic drugs; and
(B) as appropriate, revise such guidelines to
reflect developments in scientific and medical
information and technology and to ensure clarity
regarding the procedures and requirements for approval
of an antibiotic drug under chapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.).
(2) Issues for review.--At a minimum, the review under
paragraph (1) shall address the appropriate animal models of
infection, in vitro techniques, valid micro-biological
surrogate markers, the use of non-inferiority versus
superiority trials, and appropriate delta values for non-
inferiority trials.
(3) Rule of construction.--Except to the extent to which
the Secretary of Health and Human Services makes revisions
under paragraph (1)(B), nothing in this section shall be
construed to repeal or otherwise affect the guidelines of the
Food and Drug Administration.
(b) Recommendations for Investigations.--
(1) Request.--The sponsor of a drug intended to be used to
treat, detect, prevent, or identify a qualifying pathogen may
request that the Secretary provide written recommendations for
nonclinical and clinical investigations which may be conducted
with the drug before it may be approved for such use under
section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355).
(2) Recommendations.--If the Secretary has reason to
believe that a drug for which a request is made under this
subsection is a qualified infections disease product, the
Secretary shall provide the person making the request written
recommendations for the nonclinical and clinical investigations
which the Secretary believes, on the basis of information
available to the Secretary at the time of the request, would be
necessary for approval under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) of such drug for the use
described in paragraph (1).
(c) Definitions.--In this section:
(1) The term ``drug'' has the meaning given to such term in
section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321).
(2) The term ``qualifying pathogen'' has the meaning given
to such term in section 505E of the Federal Food, Drug, and
Cosmetic Act, as added by section 3 of this Act.
(3) The term ``Secretary'' means the Secretary of Health
and Human Services, acting through the Commissioner of Food and
Drugs.
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