1.This Act may be cited as the
Generating Antibiotic Incentives Now
Act of 2011
.
2.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.
3.Extension of
exclusivity period for drugs
(a)The Federal Food, Drug, and Cosmetic Act is amended by
inserting after section 505D (21 U.S.C. 355e) the following:
505E.Extension of
exclusivity period for new qualified infectious disease products
(a)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 exclusivityAny 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)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)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)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)In
this section:
(1)Qualified
infectious disease productThe term qualified infectious
disease product means an antibiotic drug for treating, detecting,
preventing, or identifying a qualifying pathogen.
(2)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)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.
4.Additional
extension of exclusivity period for qualified infectious disease products for
which a companion diagnostic test is cleared or approvedThe 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:
505E–1.Additional
extension of exclusivity for qualified infectious disease products for which a
companion diagnostic test is cleared or approved
(a)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
requirementsFor 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 testFor 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 exclusivityAny
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)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)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)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.
.
5.
(a)Chapter
V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after
section 524 (21 U.S.C. 360n) the following:
524A.Priority
review for qualified infectious disease products
(a)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)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)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.
6.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
.
7.Study on
incentives for qualified infectious disease biological products
(a)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)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.
8.
(a)Review and
revision of guidelines
(1)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)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)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)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)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)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.