Short title

This Act may be cited as the

Food and Drug Administration Improvement Act of 2005

Fees paid by manufacturers to Food and Drug Administration; deposit in general fund of Treasury; direct spending

(a)

In general

Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et seq.) is amended by adding at the end the following part:

Modifications regarding user-fee programs

740A.

Deposit of fees in general fund of Treasury; direct spending

(a)

Deposit in general fund

Notwithstanding part 2, part 3, and part 4, all fees collected under such parts shall be deposited in the general fund of the Treasury. (b)

Direct spending

(1)

In general

Notwithstanding part 2, part 3, and part 4, amounts are available to the Secretary for obligation in accordance with the following: (A) The amount specified in section 736(g)(3) for a fiscal year is, to the extent described in section 736(g)(2)(A)(ii), available to the Secretary for obligation solely for the process for the review of human drug applications (as defined in section 735). (B)The amount specified in section 738(h)(3) for a fiscal year is, to the extent described in section 738(h)(2)(A)(ii), available to the Secretary for obligation solely for the process for the review of device applications (as defined in section 737). (C)The amount specified in section 740(g)(3) for a fiscal year is, to the extent described in section 740(g)(2)(A)(ii), available to the Secretary for obligation solely for the process for the review of animal drug applications (as defined in section 739). (2)

List of mandatory appropriations

The program of spending established in paragraph (1) shall be considered entitlement authority within the meaning of section 250(17) of the Balanced Budget and Emergency Deficit Control Act of 1985.

740B.

Termination of authority for negotiations with manufacturers on use of fees

(a)

In general

With respect to persons from whom fees are collected under part 2, part 3, or part 4: (1)Notwithstanding such parts, the following applies on and after the date of the enactment of the Food and Drug Administration Improvement Act of 2005: (A)The Secretary may not enter into agreements with such persons on particular uses of the fees, including agreements on priorities, performance goals, or other commitments relating to— (i)review times for human drug applications or supplements within the meaning of part 2; (ii)review times for premarket applications, premarket reports, premarket notification submissions, or supplements within the meaning of part 3; or (iii)review times for animal drug applications or supplements within the meaning of part 4. (B)The Secretary may not otherwise negotiate understandings with such persons on particular uses of the fees. (2)Notwithstanding such parts, the following applies on and after October 1, 2005: (A)Any such agreement or understanding that was in effect on the day before the date of the Food and Drug Administration Improvement Act of 2005 is terminated, including agreements or understandings pursuant to letters referred to in section 502(4) of Public Law 107–188 (116 Stat. 688), section 101(3) of Public Law 107–250 (116 Stat. 1589), and section 2(3) of Public Law 108–130 (117 Stat. 1361). (B)The Secretary is relieved of responsibility for meeting any particular goals concerning such review times that were established in such letters. (b)

Rules of construction

Subsection (a) may not be construed— (1) as affecting the responsibility of the Secretary to work toward the general goal of administering this Act efficiently, including the review of applications, reports, supplements and other submissions referred to in subsection (a)(1)(A); or (2)as terminating requirements for the collection of fees under part 2, part 3, and part 4.

(b)

Applicability

Section 740A of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a) of this section, applies with respect to fiscal year 2006 and subsequent fiscal years.

Establishment of Center for Postmarket Drug Safety and Effectiveness

(a)

In general

Chapter V of the the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 505B the following sections:

505C.

Center for Postmarket Drug Safety and Effectiveness

(a)

Establishment

Not later than 180 days after the date of the enactment of the Food and Drug Administration Improvement Act of 2005, the Secretary shall establish within the Food and Drug Administration a center to be known as the Center for Postmarket Drug Safety and Effectiveness (referred to in this section as the Center), which shall be headed by a director appointed by the Secretary (without regard to the delegation to the Commissioner of Food and Drugs under section 903(d)(2)). The Center shall be established as a separate center at the organizational level immediately below the Office of the Commissioner. The Director of the Center shall report directly to the Commissioner. (b)

Duties

(1)

In general

The Director of the Center shall have the principal responsibility within the Food and Drug Administration, below the Office of the Commissioner, for assisting the Commissioner in regulating approved drugs, other than with respect to section 501. Such assistance includes assistance with the following: (A)Administering enforcement authorities under chapter III, including civil penalties under section 303(f). (B)Administering section 502. (C)Administering requirements for studies that were required as conditions for the approval of applications under section 505 (which studies are conducted after such approval). (D)Administering authorities under sections 505D and 505E. (E)Monitoring approved drugs to determine whether there are any issues regarding safety and effectiveness. (F)With respect to issues identified under subparagraph (E), taking action under the provisions referred to in subparagraphs (A) through (D), including as appropriate the following: (i)Establishing requirements for advertising under section 502(n). (ii)Establishing requirements for modifications in labeling under section 502(x), including the specification of a date by which the modifications are required to be made. (iii)Withdrawing the approval of drugs under section 505(e). (iv)Requiring reports under section 505(k) on clinical experience with approved drugs, including reports on the number of individuals using the drugs as indicated by sales of the drugs at retail and reports on information possessed by manufacturers on usage of the drugs. (v)Requiring notifications under section 505D(a)(1) to eliminate unreasonable risks of substantial harm to the public health. (vi)Establishing restrictions under section 505D(a)(2) to ensure the safe use of approved drugs, including requirements for— (I)the specific manner of obtaining the informed consent of patients to undergo treatment with the drugs; (II)providing education to physicians; (III)providing education to patients; and (IV)the establishment of risk-management plans by manufacturers. (vii)Requiring the conduct of studies under section 505E. (2)

Transfers

The Secretary shall transfer to the Center all responsibilities for the matters referred to in paragraph (1) that, on the day before the date of the enactment of the Food and Drug Administration Improvement Act of 2005, were vested in the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. (c)

Interactions with other centers

(1)

Consultation

The Director of the Center shall carry out this section in consultation with the Directors of the Centers referred to in subsection (b)(2). (2)

Access to information

The Secretary shall ensure that the Director of the Center has full access to all information possessed by the Food and Drug Administration that relates to the safety and effectiveness of approved drugs, including information possessed by the Centers referred to in subsection (b)(2). (d)

Definition

For purposes of this section, the term approved drug means a drug for which an approved application under section 505 is in effect or for which a biologics license under section 351 of the Public Health Service Act is in effect. (e)

Funding

For the purpose of carrying out this section, the Secretary shall make available for a fiscal year, from the amount appropriated for the Food and Drug Administration for such year, the following amount, as applicable to such year: (1)For fiscal year 2006, $100,000,000. (2)For fiscal year 2007, $125,000,000. (3)For fiscal year 2008, $150,000,000. (4)For fiscal year 2009, $175,000,000. (5)For fiscal year 2010, $200,000,000.

505D.

Certain postmarket authorities

(a)

In general

Effective on and after the date of the enactment of the Food and Drug Administration Improvement Act of 2005, the Secretary has with respect to approved drugs the same authorities as the Secretary has with respect to devices under the following provisions: (1)Section 518(a) (relating to notifications to eliminate an unreasonable risk of substantial harm to the public health). (2)Section 520(e)(1)(B) (relating to restrictions on sale, distribution, or use). (3)Section 520(h) (relating to making available to the public summaries of information respecting safety and effectiveness). (b)

Definition

For purposes of this section, the term approved drug has the meaning given such term in section 505C(d).

505E.

Postmarket studies regarding safety of drugs

(a)

Phase 4 studies

The Secretary may require that the manufacturer of an approved drug conduct one or more studies to confirm or refute an empirical or theoretical hypothesis of a significant safety issue with the drug (whether raised with respect to the product directly or with respect to the class of the product) that has been identified pursuant to— (1)the MedWatch postmarket surveillance system; (2)a clinical or epidemiological study; (3)the scientific literature; (4)a foreign government that regulates drugs or devices; (5)an international organization concerned with the safety or effectiveness of drugs or devices; or (6)such other sources as the Secretary determines to be appropriate. (b)

Approval of protocol; timeframe

A study under subsection (a) shall be conducted in accordance with a protocol approved by the Secretary. In requiring such a study, the Secretary shall specify a timeframe for completing the study. (c)

Public disclosure

(1)

Internet site

Notwithstanding 506B, the Secretary shall maintain on the Internet site of the Food and Drug Administration a database that provides information on each study required under subsection (a), including a description of and the reason for the study, the required completion date, and whether the study has been completed. The Secretary shall update the database not less frequently than once each quarter. (2)

Federal register

Not later than 30 days after first establishing the databank under paragraph (1), the Secretary shall, with respect to studies required under subsection (a), publish in the Federal Register the same information as is included in such database as of the date of such publication. Thereafter, the Secretary shall publish in the Federal Register, not less frequently than once each quarter, updates that reflect the updates made under paragraph (1). (d)

Definition

For purposes of this section, the term approved drug has the meaning given such term in section 505C(d).

(b)

Certain studies

(1)

In general

With respect to section 505E(c) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a) of this section), each study described in paragraph (2) is deemed to be a study to which such section applies. (2)

Relevant studies

For purposes of paragraph (1), a study described in this paragraph is a study that— (A)relates to the safety or effectiveness of a drug; (B)was in progress as of the date of the enactment of this Act; and (C)was conducted pursuant to an agreement that, or or after January 1, 2003, was entered into with the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs.

Order regarding postmarket labeling

Section 502 of the the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following:

(x)If it is a drug and the Secretary determines that its labeling fails to provide information, including specific wording, required by the Secretary by order on the basis that the information is necessary to ensure its safe and effective use.

Additional enforcement provisions

(a)

Postmarket authorities

Section 502 of the the Federal Food, Drug, and Cosmetic Act, as amended by section 4 of this Act, is amended by adding at the end the following:

(y)If it is a drug with respect to which there is a failure to comply with any requirement under section 505D or 505E.

(b)

Civil penalties for violations of requirements relating to drugs

Section 303(f) of the the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is amended— (1)by redesignating paragraphs (3) through (5) as paragraphs (4) through (6), respectively; (2)by inserting after paragraph (2) the following paragraph:

(3)Any person who violates a requirement of this Act which relates to drugs shall be liable to the United States for a civil penalty in an amount not exceeding $50,000 per day for each such violation, not to exceed $50,000,000 for all such violations adjudicated in a single proceeding.

;

(3)in paragraph (4) (as so redesignated) by striking paragraph (1) or (2) each place such term appears and inserting paragraph (1), (2), or (3); and (4)in paragraph (5) (as so redesignated), by striking paragraph (3)(A) and inserting paragraph (4)(A); and (5)in paragraph (6) (as so redesignated), by striking paragraph (4) each place such term appears and inserting paragraph (5).

Preemption

(a)

In general

With respect to the issue of whether a provision of chapter V of the Federal Food, Drug, and Cosmetic Act or of section 351 of the Public Health Service Act (or regulations or orders under such a provision) supersedes the law of a State, the Secretary of Health and Human Services (referred to in this section as the Secretary) shall follow, without change, the interpretation that was followed by the Food and Drug Administration in 1999, including the interpretation that such Administration does not believe that the evolution of state tort law will cause the development of standards that would be at odds with the agency’s regulations and that such regulations establish minimal standards but are not intended to preclude the States from imposing additional requirements (63 FR 66384). (b)

Product liability cases

In the case of civil actions regarding product liability that are brought in State courts against manufacturers of drugs or devices, policies of the Secretary required under subsection (a) include the policy that the Secretary cease intervening in such actions to argue any interpretation contrary to such subsection.

Additional provisions

(a)

Requirements regarding membership of advisory committees

Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at the end the following section:

712.

Requirements regarding membership of advisory committees

(a)

In general

Notwithstanding any other provision of law, the Secretary shall comply with the following with respect to any meeting of an advisory committee convened by the Secretary under this Act: (1)Not later than 30 days before such meeting, the Secretary shall post on the Internet site of the Food and Drug Administration the agenda for the meeting and the tentative list of all proposed advisory committee members, together with a short biography of each such prospective member. (2)After compliance with paragraph (1), the Secretary shall provide the public not fewer than 20 days to submit to the Secretary comments on the proposed membership of the advisory committee. (3)The Secretary shall consider the public comments to determine whether any adjustment to the roster of the advisory committee is necessary to make the committee fairly balanced. (4)Not later than three days before the start of the meeting, the Secretary shall post on such Internet site the final membership of the advisory committee. (b)

Conflicts of interest

Notwithstanding any other provision of law, a member of an advisory committee under this Act may not, with respect to service on such committee, be granted an exemption under section 208(b) of title 18, United States Code (relating to personal financial interests). (c)

Definitions

For purposes of this section: (1)The term advisory committee has the same meaning given such term in section 3(2) of the Federal Advisory Committee Act. (2)The term fairly balanced has the same meaning as applies to such term under section 5(b)(2) of the Federal Advisory Committee Act.

(b)

Certain uses of approved drugs

Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the end the following section:

910.

Requirement regarding informed consent for certain treatments

With respect to the prescribing of a drug for a use not included in the approved labeling for the drug under section 505 or under section 351 of the Public Health Service Act, the Secretary shall promulgate regulations requiring that, before prescribing the drug— (1)the physician inform the patient that the use for which the physician intends to prescribe the drug has not been approved by the Food and Drug Administration; and (2)the physician obtain from the patient an acknowledgment of such fact and the consent of the patient to use the drug for such use notwithstanding such fact.