HR 2182 IHCommentsClose CommentsPermalink

112th CONGRESSCommentsClose CommentsPermalink

1st SessionCommentsClose CommentsPermalink

H. R. 2182CommentsClose CommentsPermalink

To provide incentives for the development of qualified infectious disease products.CommentsClose CommentsPermalink

IN THE HOUSE OF REPRESENTATIVESCommentsClose CommentsPermalink

June 15, 2011CommentsClose CommentsPermalink

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 CommerceCommentsClose CommentsPermalink

A BILLCommentsClose CommentsPermalink

To provide incentives for the development of qualified infectious disease products.CommentsClose CommentsPermalink

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Generating Antibiotic Incentives Now Act of 2011’.CommentsClose CommentsPermalink

SEC. 2. TABLE OF CONTENTS.

The table of contents of this Act is as follows:CommentsClose CommentsPermalink





Sec. 1. Short title.CommentsClose CommentsPermalink





Sec. 2. Table of contents.CommentsClose CommentsPermalink





Sec. 3. Extension of exclusivity period for drugs.CommentsClose CommentsPermalink





Sec. 4. Additional extension of exclusivity period for qualified infectious disease products for which a companion diagnostic test is cleared or approved.CommentsClose CommentsPermalink





Sec. 5. Priority review.CommentsClose CommentsPermalink





Sec. 6. Fast track product.CommentsClose CommentsPermalink





Sec. 7. Study on incentives for qualified infectious disease biological products.CommentsClose CommentsPermalink





Sec. 8. Clinical trials.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

‘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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(c) Limitations- Subsection (a) does not apply to the approval of--CommentsClose CommentsPermalink





‘(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; orCommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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; orCommentsClose CommentsPermalink





‘(B) a modification to the structure of the qualified infectious disease product that does not result in a change in safety or effectiveness.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(f) Definitions- In this section:CommentsClose CommentsPermalink





‘(1) QUALIFIED INFECTIOUS DISEASE PRODUCT- The term ‘qualified infectious disease product’ means an antibiotic drug for treating, detecting, preventing, or identifying a qualifying pathogen.CommentsClose CommentsPermalink





‘(2) QUALIFYING PATHOGEN- The term ‘qualifying pathogen’ means--CommentsClose CommentsPermalink





‘(A) resistant gram positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Staphylococcus aureus (VRSA), and vancomycin-resistant enterococcus (VRE);CommentsClose CommentsPermalink





‘(B) multi-drug resistant gram negative bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli species;CommentsClose CommentsPermalink





‘(C) multi-drug resistant tuberculosis; orCommentsClose CommentsPermalink





‘(D) any other infectious pathogen identified for purposes of this section by the Secretary.’.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

‘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.CommentsClose CommentsPermalink





‘(b) Identification Requirements- For purposes of subsection (a), the identification of a companion diagnostic test shall--CommentsClose CommentsPermalink





‘(1) be made in such manner as the Secretary may require; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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:CommentsClose CommentsPermalink





‘(1) The device is determined by the Secretary under subsection (f) to be a test for diagnosis of a qualifying pathogen.CommentsClose CommentsPermalink





‘(2) The qualified infectious disease product has been determined under section 505E(d) to be for treating, detecting, preventing, or identifying such qualifying pathogen.CommentsClose CommentsPermalink





‘(3) The device is cleared under section 510(k) or approved under section 515.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(1) any subsequent extension with respect to such product; orCommentsClose CommentsPermalink





‘(2) any extension with respect to any other product pursuant to identification of such device.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(g) Definitions- In this section:CommentsClose CommentsPermalink





‘(1) The term ‘qualified infectious disease product’ means a drug that is determined to be a qualified infectious disease product under section 505E.CommentsClose CommentsPermalink





‘(2) The term ‘qualifying pathogen’ has the meaning given to such term in section 505E.’.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

‘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).CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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’.CommentsClose CommentsPermalink

SEC. 7. STUDY ON INCENTIVES FOR QUALIFIED INFECTIOUS DISEASE BIOLOGICAL PRODUCTS.

(a) In General- The Comptroller General of the United States shall--CommentsClose CommentsPermalink





(1) conduct a study on the need for incentives to encourage the research, development, and marketing of qualified infectious disease biological products; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(b) Definitions- In this section:CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





(2) The term ‘qualified infectious disease biological product’ means a biological product for treating, detecting, preventing, or identifying a qualifying pathogen.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

SEC. 8. CLINICAL TRIALS.

(a) Review and Revision of Guidelines-CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(A) review the guidelines of the Food and Drug Administration for the conduct of clinical trials with respect to antibiotic drugs; andCommentsClose CommentsPermalink





(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.).CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(b) Recommendations for Investigations-CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





(c) Definitions- In this section:CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(3) The term ‘Secretary’ means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs.CommentsClose CommentsPermalink