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HR 2900 continued

HR 2900 Continued

SEC. 603. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.
Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the following:
`SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.
`(a) Establishment- The Secretary, acting through the Commissioner of Food and Drugs, shall enter into collaborative agreements, to be known as Critical Path Public-Private Partnerships, with one or more eligible entities to implement the Critical Path Initiative of the Food and Drug Administration by developing innovative, collaborative projects in research, education, and outreach for the purpose of fostering medical product innovation, enabling the acceleration of medical product development, and enhancing medical product safety.
`(b) Eligible Entity- In this section, the term `eligible entity’ means an entity that meets each of the following:
`(1) The entity is–
`(A) an institution of higher education (as such term is defined in section 101 of the Higher Education Act of 1965); or
`(B) an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 and exempt from tax under section 501(a) of such Code.
`(2) The entity has experienced personnel and clinical and other technical expertise in the biomedical sciences.
`(3) The entity demonstrates to the Secretary’s satisfaction that the entity is capable of–
`(A) developing and critically evaluating tools, methods, and processes–
`(i) to increase efficiency, predictability, and productivity of medical product development; and
`(ii) to more accurately identify the benefits and risks of new and existing medical products;
`(B) establishing partnerships, consortia, and collaborations with health care practitioners and other providers of health care goods or services; pharmacists; pharmacy benefit managers and purchasers; health maintenance organizations and other managed health care organizations; health care insurers; government agencies; patients and consumers; manufacturers of prescription drugs, biological products, diagnostic technologies, and devices; and academic scientists; and
`(C) securing funding for the projects of a Critical Path Public-Private Partnership from Federal and nonfederal governmental sources, foundations, and private individuals.
`(c) Funding- The Secretary may not enter into a collaborative agreement under subsection (a) unless the eligible entity involved provides an assurance that the entity will not accept funding for a Critical Path Public-Private Partnership project from any organization that manufactures or distributes products regulated by the Food and Drug Administration unless–
`(1) the entity accepts such funding for such project from 2 or more such organizations; and
`(2) the entity provides assurances in its agreement with the Food and Drug Administration that the results of the Critical Path Public-Private Partnership project will not be influenced by any source of funding.
`(d) Annual Report- Not later than 18 months after the date of the enactment of this section, and annually thereafter, the Secretary, in collaboration with the parties to each Critical Path Public-Private Partnership, shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives–
`(1) reviewing the operations and activities of the Partnerships in the previous year; and
`(2) addressing such other issues relating to this section as the Secretary determines to be appropriate.
`(e) Definition- In this section, the term `medical product’ includes a drug, a biological product, a device, and any combination of such products.
`(f) Authorization of Appropriations- To carry out this section, there are authorized to be appropriated $5,000,000 for fiscal year 2008 and such sums as may be necessary for each of fiscal years 2009 through 2012.’.
TITLE VII–CONFLICTS OF INTEREST
SEC. 701. CONFLICTS OF INTEREST.
(a) In General- Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by inserting at the end the following:
`SEC. 712. CONFLICTS OF INTEREST.
`(a) Definitions- For purposes of this section:
`(1) ADVISORY COMMITTEE- The term `advisory committee’ means an advisory committee under the Federal Advisory Committee Act that provides advice or recommendations to the Secretary regarding activities of the Food and Drug Administration.
`(2) FINANCIAL INTEREST- The term `financial interest’ means a financial interest under section 208(a) of title 18, United States Code.
`(b) Appointments to Advisory Committees-
`(1) RECRUITMENT-
`(A) IN GENERAL- Given the importance of advisory committees to the review process at the Food and Drug Administration, the Secretary, through the Office of Women’s Health, the Office of Orphan Product Development, the Office of Pediatric Therapeutics, and other offices within the Food and Drug Administration with relevant expertise, shall develop and implement strategies on effective outreach to potential members of advisory committees at universities, colleges, other academic research centers, professional and medical societies, and patient and consumer groups. The Secretary shall seek input from professional medical and scientific societies to determine the most effective informational and recruitment activities. The Secretary shall also take into account the advisory committees with the greatest number of vacancies.
`(B) RECRUITMENT ACTIVITIES- The recruitment activities under subparagraph (A) may include–
`(i) advertising the process for becoming an advisory committee member at medical and scientific society conferences;
`(ii) making widely available, including by using existing electronic communications channels, the contact information for the Food and Drug Administration point of contact regarding advisory committee nominations; and
`(iii) developing a method through which an entity receiving funding from the National Institutes of Health, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, or the Veterans Health Administration can identify a person who the Food and Drug Administration can contact regarding the nomination of individuals to serve on advisory committees.
`(2) EVALUATION AND CRITERIA- When considering a term appointment to an advisory committee, the Secretary shall review the expertise of the individual and the financial disclosure report filed by the individual pursuant to the Ethics in Government Act of 1978 for each individual under consideration for the appointment, so as to reduce the likelihood that an appointed individual will later require a written determination as referred to in section 208(b)(1) of title 18, United States Code, a written certification as referred to in section 208(b)(3) of title 18, United States Code, or a waiver as referred to in subsection (c)(3) of this section for service on the committee at a meeting of the committee.
`(3) PARTICIPATION OF GUEST EXPERT WITH FINANCIAL INTEREST- Notwithstanding any other provision of this section, an individual with a financial interest with respect to any matter considered by an advisory committee may be allowed to participate in a meeting of an advisory committee as a guest expert if the Secretary determines that the individual has particular expertise required for the meeting. An individual participating as a guest expert may provide information and expert opinion, but shall not participate in the discussion or voting by the members of the advisory committee.
`(c) Granting and Disclosure of Waivers-
`(1) IN GENERAL- Prior to a meeting of an advisory committee regarding a `particular matter’ (as that term is used in section 208 of title 18, United States Code), each member of the committee who is a full-time Government employee or special Government employee shall disclose to the Secretary financial interests in accordance with subsection (b) of such section 208.
`(2) FINANCIAL INTEREST OF ADVISORY COMMITTEE MEMBER OR FAMILY MEMBER- No member of an advisory committee may vote with respect to any matter considered by the advisory committee if such member (or an immediate family member of such member) has a financial interest that could be affected by the advice given to the Secretary with respect to such matter, excluding interests exempted in regulations issued by the Director of the Office of Government Ethics as too remote or inconsequential to affect the integrity of the services of the Government officers or employees to which such regulations apply.
`(3) WAIVER- The Secretary may grant a waiver of the prohibition in paragraph (2) if such waiver is necessary to afford the advisory committee essential expertise.
`(4) LIMITATIONS-
`(A) ONE WAIVER PER COMMITTEE MEETING- Notwithstanding any other provision of this section, with respect to each advisory committee, the Secretary shall not grant more than 1 waiver under paragraph (3) per committee meeting.
`(B) SCIENTIFIC WORK- The Secretary may not grant a waiver under paragraph (3) for a member of an advisory committee when the member’s own scientific work is involved.
`(5) DISCLOSURE OF WAIVER- Notwithstanding section 107(a)(2) of the Ethics in Government Act (5 U.S.C. App.), the following shall apply:
`(A) 15 OR MORE DAYS IN ADVANCE- As soon as practicable, but in no case later than 15 days prior to a meeting of an advisory committee to which a written determination as referred to in section 208(b)(1) of title 18, United States Code, a written certification as referred to in section 208(b)(3) of title 18, United States Code, or a waiver as referred to in paragraph (3) applies, the Secretary shall disclose (other than information exempted from disclosure under section 552 of title 5, United States Code, and section 552a of title 5, United States Code (popularly known as the Freedom of Information Act and the Privacy Act of 1974, respectively)) on the Internet website of the Food and Drug Administration–
`(i) the type, nature, and magnitude of the financial interests of the advisory committee member to which such determination, certification, or waiver applies; and
`(ii) the reasons of the Secretary for such determination, certification, or waiver.
`(B) LESS THAN 30 DAYS IN ADVANCE- In the case of a financial interest that becomes known to the Secretary less than 30 days prior to a meeting of an advisory committee to which a written determination as referred to in section 208(b)(1) of title 18, United States Code, a written certification as referred to in section 208(b)(3) of title 18, United States Code, or a waiver as referred to in paragraph (3) applies, the Secretary shall disclose (other than information exempted from disclosure under section 552 of title 5, United States Code, and section 552a of title 5, United States Code) on the Internet website of the Food and Drug Administration, the information described in clauses (i) and (ii) of subparagraph (A) as soon as practicable after the Secretary makes such determination, certification, or waiver, but in no case later than the date of such meeting.
`(d) Public Record- The Secretary shall ensure that the public record and transcript of each meeting of an advisory committee includes the disclosure required under subsection (c)(5) (other than information exempted from disclosure under section 552 of title 5, United States Code, and section 552a of title 5, United States Code).
`(e) Annual Report- Not later than February 1 of each year, the Secretary shall submit to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives a report that describes–
`(1) with respect to the fiscal year that ended on September 30 of the previous year, the number of vacancies on each advisory committee, the number of nominees received for each committee, and the number of such nominees willing to serve;
`(2) with respect to such year, the aggregate number of disclosures required under subsection (c)(5) for each meeting of each advisory committee and the percentage of individuals to whom such disclosures did not apply who served on such committee for each such meeting;
`(3) with respect to such year, the number of times the disclosures required under subsection (c)(5) occurred under subparagraph (B) of such subsection; and
`(4) how the Secretary plans to reduce the number of vacancies reported under paragraph (1) during the fiscal year following such year, and mechanisms to encourage the nomination of individuals for service on an advisory committee, including those who are classified by the Food and Drug Administration as academicians or practitioners.
`(f) Periodic Review of Guidance- Not less than once every 5 years, the Secretary shall review guidance of the Food and Drug Administration regarding conflict of interest waiver determinations with respect to advisory committees and update such guidance as necessary.’.
(b) Conforming Amendment- Section 505(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended–
(1) by striking paragraph (4); and
(2) by redesignating paragraphs (5), (6), (7), and (8) as paragraphs (4), (5), (6), and (7), respectively.
(c) Effective Date- The amendments made by this section shall take effect on October 1, 2007.
TITLE VIII–CLINICAL TRIAL DATABASES
SEC. 801. CLINICAL TRIAL REGISTRY DATABASE AND CLINICAL TRIAL RESULTS DATABASE.
(a) In General- Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended–
(1) in section 402, by striking subsection (i); and
(2) by inserting after section 492B the following new section:
`SEC. 492C. CLINICAL TRIAL REGISTRY DATABASE; CLINICAL TRIAL RESULTS DATABASE.
`(a) Definitions- In this section:
`(1) APPLICABLE CLINICAL TRIAL- The term `applicable clinical trial’–
`(A) means a clinical trial that is conducted to test the safety or effectiveness (including comparative effectiveness) of a drug or device (irrespective of whether the clinical trial is federally or privately funded, and whether the clinical trial involves an approved or unapproved drug or device);
`(B) includes such a clinical trial that is conducted outside of the United States if–
`(i) there is an application or premarket notification pending before the Food and Drug Administration for approval or clearance of the drug or device involved under section 505, 510(k), or 515 of the Federal Food, Drug, and Cosmetic Act or section 351 of this Act; or
`(ii) the drug or device involved is so approved or cleared; and
`(C) notwithstanding subparagraphs (A) and (B), excludes–
`(i) a clinical trial to determine the safety of a use of a drug that is designed solely to detect major toxicities in the drug or to investigate pharmacokinetics, unless the clinical trial is designed to investigate pharmacokinetics in a special population or populations; and
`(ii) a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the primary focus is feasibility.
`(2) CLINICAL TRIAL INFORMATION- The term `clinical trial information’ means those data elements that are necessary to complete an entry in the clinical trial registry database under subsection (b) or the clinical trial results database under subsection (c), as applicable.
`(3) COMPLETION DATE- The term `completion date’ means the date of the final collection of data from subjects in the clinical trial for the primary and secondary outcomes to be examined in the trial.
`(4) DEVICE- The term `device’ has the meaning given to that term in section 201(h) of the Federal Food, Drug, and Cosmetic Act.
`(5) DRUG- The term `drug’ means a drug as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act or a biological product as defined in section 351 of this Act.
`(6) RESPONSIBLE PARTY- The term `responsible party’, with respect to an applicable clinical trial, means–
`(A) the primary sponsor (as defined in the International Clinical Trials Registry Platform trial registration data set of the World Health Organization) of the clinical trial; or
`(B) the principal investigator of such clinical trial if so designated by such sponsor, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data, has the right to publish the results of the trial, and has the responsibility to meet all of the requirements under this section that are applicable to responsible parties.
`(b) Clinical Trials Registry Database-
`(1) ESTABLISHMENT- To enhance patient enrollment and provide a mechanism to track subsequent progress of clinical trials, the Secretary, acting through the Director of NIH, shall establish and administer a clinical trial registry database in accordance with this section (referred to in this section as the `registry database’). The Director of NIH shall ensure that the registry database is made publicly available through the Internet.
`(2) CONTENT- The Secretary shall promulgate regulations for the submission to the registry database of clinical trial information that–
`(A) conforms to the International Clinical Trials Registry Platform trial registration data set of the World Health Organization;
`(B) includes the city, State, and zip code for each clinical trial location or a toll free number through which such location information may be accessed;
`(C) includes a statement of the estimated completion date for the clinical trial;
`(D) includes the identity and contact information of the responsible party;
`(E) if the drug is not approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act, or the device is not cleared under section 510(k) or approved under section 515 of the Federal Food, Drug, and Cosmetic Act, specifies whether or not there is expanded access to the drug or device under section 561 of the Federal Food, Drug, and Cosmetic Act for those who do not qualify for enrollment in the clinical trial and how to obtain information about such access;
`(F) includes, with respect to any individual who is not an employee of the responsible party for the clinical trial or of the manufacturer of the drug or device involved, information on whether the responsible party or manufacturer has entered into any agreement with such individual that restricts in any manner the ability of the individual–
`(i) to discuss the results of the trial at a scientific meeting or any other public or private forum; or
`(ii) to publish the results of the trial, or a description or discussion of the results of the trial, in a scientific or academic journal; and
`(G) requires the inclusion of such other data elements to the registry database as appropriate.
`(3) FORMAT AND STRUCTURE-
`(A) SEARCHABLE CATEGORIES- The Director of NIH shall ensure that the public may search the entries in the registry database by 1 or more of the following criteria:
`(i) The indication being studied in the clinical trial, using Medical Subject Headers (MeSH) descriptors.
`(ii) The safety issue being studied in the clinical trial.
`(iii) The enrollment status of the clinical trial.
`(iv) The sponsor of the clinical trial.
`(B) FORMAT- The Director of the NIH shall ensure that the registry database is easily used by patients, and that entries are easily compared.
`(4) DATA SUBMISSION- The responsible party for an applicable clinical trial shall submit to the Director of NIH for inclusion in the registry database the clinical trial information described in paragraph (2).
`(5) TRUTHFUL CLINICAL TRIAL INFORMATION-
`(A) IN GENERAL- The clinical trial information submitted by a responsible party under this subsection shall not be false or misleading.
`(B) EFFECT- Subparagraph (A) shall not have the effect of requiring clinical trial information to include information from any source other than the clinical trial involved.
`(6) TIMING OF SUBMISSION- Except as provided in paragraph (7), the clinical trial information for a clinical trial required to be submitted under this subsection shall be submitted not later than 14 days after the first patient is enrolled in such clinical trial.
`(7) UPDATES- The responsible party for an applicable clinical trial shall submit to the Director of NIH for inclusion in the registry database periodic updates to reflect changes to the clinical trial information submitted under this subsection. Such updates–
`(A) shall be provided not less than once every 6 months until information on the results of the trial is submitted under subsection (c);
`(B) shall include identification of the dates of any such changes;
`(C) not later than 30 days after the enrollment status of such clinical trial changes, shall include an update of the enrollment status; and
`(D) not later than 30 days after the completion date of the clinical trial, shall include a report to the Director that such clinical trial is complete.
`(8) APPLICABILITY OF DEVICE TRIALS- In the case of an applicable clinical trial regarding a device, the responsible person for the trial shall submit to the Director of NIH the clinical trial information as required in paragraph (4), but the Director may not make the information publicly available through the registry database until the device is approved or cleared (as the case may be).
`(c) Clinical Trials Results Database-
`(1) ESTABLISHMENT- To ensure that results of clinical trials are made public and that patients and providers have current information regarding the results of clinical trials, the Secretary, acting through the Director of NIH, shall establish and administer a clinical trial results database in accordance with this section (referred to in this section as the `results database’). The Director of NIH shall ensure that the results database is made publicly available through the Internet.
`(2) SEARCHABLE CATEGORIES- The Director of NIH shall ensure that the public may search the entries in the results database by 1 or more of the following:
`(A) The indication studied in the clinical trial, using Medical Subject Headers (MeSH) descriptors.
`(B) The safety issue studied in the clinical trial.
`(C) Whether an application for the tested indication is approved, pending approval, withdrawn, or not submitted.
`(D) The phase of the clinical trial.
`(E) The name of the drug or device that is the subject of the clinical trial.
`(F) Within the documents described in clauses (i) and (ii) of paragraph (3)(B), the following information, as applicable:
`(i) The sponsor of the clinical trial.
`(ii) Each financial sponsor of the clinical trial.
`(3) CONTENTS-
`(A) IN GENERAL- The responsible party for an applicable clinical trial shall submit to the Director of NIH for inclusion in the results database the clinical trial information described in subparagraph (B).
`(B) REQUIRED ELEMENTS- In submitting clinical trial information for a clinical trial to the Director of NIH for inclusion in the results database, the responsible party shall include, with respect to such clinical trial, the following information:
`(i) The information described in subparagraphs (A) through (E) of subsection (b)(2).
`(ii) A summary that is written in non-technical, understandable language for patients that includes the following:
`(I) The purpose of the clinical trial.
`(II) The sponsor of the clinical trial.
`(III) A point of contact for information about the clinical trial.
`(IV) A description of the patient population tested in the clinical trial.
`(V) A general description of the clinical trial and results, including a description of and the reasons for any changes in the clinical trial design that occurred since the date of submission of clinical trial information for inclusion in the registry database established under subsection (b) and a description of any significant safety information.
`(iii) A summary that is technical in nature that includes the following:
`(I) The purpose of the clinical trial.
`(II) The sponsor of the clinical trial.
`(III) Each financial sponsor of the clinical trial.
`(IV) A point of contact for scientific information about the clinical trial.
`(V) A description of the patient population tested in the clinical trial.
`(VI) A general description of the clinical trial and results, including a description of and the reasons for any changes in the clinical trial design that occurred since the date of submission of clinical trial information for the clinical trial in the registry database established under subsection (b).
`(VII) Summary data describing the results, including–
`(aa) whether the primary endpoint was achieved, including relevant statistics;
`(bb) an assessment of any secondary endpoints, if applicable, including relevant statistics; and
`(cc) any significant safety information, including a summary of the incidence of serious adverse events observed in the clinical trial and a summary of the most common adverse events observed in the clinical trial and the frequencies of such events.
`(iv) With respect to the group of subjects receiving the drug or device involved, and each comparison group of subjects, the percentage of individuals who ceased participation as subjects and the reasons for ceasing participation.
`(v) With respect to an individual who is not an employee of the responsible party for the clinical trial or of the manufacturer of the drug or device involved, information (to the extent not submitted under subsection (b)(2)(F)) on any agreement that the responsible party or manufacturer has entered into with such individual that restricts in any manner the ability of the individual–
`(I) to discuss the results of the trial at a scientific meeting or any other public or private forum; or
`(II) to publish the results of the trial, or a description or discussion of the results of the trial, in a scientific or academic journal.
`(vi) The completion date of the clinical trial.
`(vii) A link to the Internet web posting of any adverse regulatory actions taken by the Food and Drug Administration, such as a warning letter, that was substantively based on the clinical trial design, outcome, or representation made by the applicant about the design or outcome of the clinical trial.
`(C) LINKS IN DATABASE- The Director of NIH shall ensure that the results database includes the following:
`(i) Links to Medline citations to publications reporting results from each applicable drug clinical trial and applicable device clinical trial.
`(ii) Links to the entry for the product that is the subject of an applicable drug clinical trial in the National Library of Medicine database of structured product labels, if available.
`(iii) Links described in clauses (i) and (ii) for data bank entries for clinical trials submitted to the data bank prior to enactment of this section, as available.
`(4) TIMING-
`(A) IN GENERAL- Except as provided in subparagraphs (B) and (C), a responsible party shall submit to the Director of NIH for inclusion in the results database clinical trial information for an applicable clinical trial not later than 1 year after the earlier of–
`(i) the estimated completion date of the trial, as submitted under subsection (b)(2); or
`(ii) the actual date of the completion, or termination before completion, of the trial, as applicable.
`(B) EXTENSIONS- The Director of NIH may provide an extension of the deadline for submission of clinical trial information under subparagraph (A) if the responsible party for the trial submits to the Director a written request that demonstrates good cause for the extension and provides an estimate of the date on which the information will be submitted. The Director of NIH may grant more than one such extension for the clinical trial involved.
`(C) UPDATES- The responsible party for an applicable clinical trial shall submit to the Director of NIH for inclusion in the results database periodic updates to reflect changes in the clinical trial information submitted under this subsection. Such updates–
`(i) shall be provided not less frequently than once every 6 months during the 10-year period beginning on the date on which information is due under subparagraph (A);
`(ii) shall identify the dates on which the changes were made; and
`(iii) shall include, not later than 30 days after any change in the regulatory status of the drug or device involved, an update informing the Director of NIH of such change.
`(5) TRUTHFUL CLINICAL TRIAL INFORMATION-
`(A) IN GENERAL- The clinical trial information submitted by a responsible party under this subsection shall not be false or misleading in any particular.
`(B) EFFECT- Subparagraph (A) shall not have the effect of requiring clinical trial information with respect to a clinical trial to include information from any source other than such clinical trial.
`(6) PUBLIC AVAILABILITY OF RESULTS-
`(A) PRE-APPROVAL STUDIES- Except as provided in subparagraph (E), with respect to an applicable clinical trial that is completed before the drug is initially approved under section 505 of the Federal Food, Drug, and Cosmetic Act or initially licensed under section 351 of this Act, or the device is initially cleared under section 510(k) or approved under section 515 of the Federal Food, Drug, and Cosmetic Act, the Director of NIH shall make publicly available on the results database the clinical trial information submitted for such clinical trial not later than 30 days after–
`(i) the drug or device is approved under such section 505, licensed under such section 351, cleared under such section 510(k), or approved under such section 515, as applicable; or
`(ii) the Secretary issues a not approvable letter or a not substantially equivalent letter for the drug or device under such section 505, 351, 510(k), or 515, as applicable.
`(B) MEDICAL AND CLINICAL PHARMACOLOGY REVIEWS OF PRE-APPROVAL STUDIES- Not later than 90 days after the date applicable under clause (i) or (ii) of subparagraph (A) with respect to an applicable clinical trial, the Director of NIH shall make publicly available on the results database a summary of the available medical and clinical pharmacology reviews conducted by the Food and Drug Administration for such trial.
`(C) POST-APPROVAL STUDIES- Except as provided in subparagraphs (D) and (E), with respect to an applicable clinical trial that is completed after the drug is initially approved under such section 505 or licensed under such section 351, or the device is initially cleared under such section 510(k) or approved under such section 515, the Director of NIH shall make publicly available on the results database the clinical trial information submitted for such clinical trial not later than 30 days after the date of such submission.
`(D) SEEKING APPROVAL OF A NEW USE FOR THE DRUG OR DEVICE-
`(i) IN GENERAL- If the manufacturer of the drug or device is the sponsor or a financial sponsor of an applicable clinical trial, and such manufacturer certifies to the Director of NIH that such manufacturer has filed, or will file within 1 year, an application seeking approval under such section 505, licensing under such section 351, clearance under such section 510(k), or approval under such section 515 for the use studied in such clinical trial (which use is not included in the labeling of the approved drug or device), then the Director of NIH shall make publicly available on the results database the clinical trial information submitted for such clinical trial on the earlier of the date that is 30 days after the date–
`(I) the new use of the drug or device is approved under such section 505, licensed under such section 351, cleared under such section 510(k), or approved under such section 515;
`(II) the Secretary issues a not approvable letter or a not substantially equivalent letter for the new use of the drug or device under such section 505, 351, 510(k), or 515; or
`(III) the application or premarket notification under such section 505, 351, 510(k), or 515 is withdrawn.
`(ii) LIMITATION ON CERTIFICATION- If a manufacturer makes a certification under clause (i) with respect to a clinical trial, the manufacturer shall make such a certification with respect to each applicable clinical trial that is required to be submitted in an application for approval of the use studied in the clinical trial.
`(iii) 2-year LIMITATION- The clinical trial information subject to clause (i) shall be made publicly available on the results database on the date that is 2 years after the date the certification referred to in clause (i) was made to the Director of NIH, if a regulatory action referred to in subclause (I), (II), or (III) of clause (i) has not occurred by such date.
`(iv) MEDICAL AND CLINICAL PHARMACOLOGY REVIEWS- Not later than 90 days after the date applicable under subclause (I), (II), or (III) of clause (i) or clause (iii) with respect to an applicable clinical trial, the Director of NIH shall make publicly available on the results database a summary of the available medical and clinical pharmacology reviews conducted by the Food and Drug Administration for such trial.
`(E) SEEKING PUBLICATION-
`(i) IN GENERAL- If the principal investigator of an applicable clinical trial is seeking publication in a peer-reviewed biomedical journal of a manuscript based on the results of the clinical trial and the responsible party so certifies to the Director of NIH–
`(I) the responsible party shall notify the Director of NIH of the publication date of such manuscript not later than 15 days after such date; and
`(II) the Director of NIH shall make publicly available on the results database the clinical trial information submitted for such clinical trial on the date that is 30 days after the publication date of such manuscript.
`(ii) LIMITATIONS- The clinical trial information subject to clause (i)–
`(I) shall be made publicly available on the results database on the date that is 2 years after the date that the clinical trial information was required to be submitted to the Director of NIH if the manuscript referred to in such clause has not been published by such date; and
`(II) shall not be required to be made publicly available under section 552 of title 5, United States Code (commonly known as the `Freedom of Information Act’), prior to the date applicable to such clinical trial information under this subparagraph.
`(7) VERIFICATION OF SUBMISSION PRIOR TO PUBLIC AVAILABILITY- In the case of clinical trial information that is submitted under this subsection, but is not made publicly available pending either regulatory action or publication under subparagraph (D) or (E) of paragraph (6), as applicable, the Director of NIH shall respond to inquiries from other Federal agencies and peer-reviewed journals to confirm that such clinical trial information has been submitted but has not yet been made publicly available on the results database.
`(d) Updates; Tracking of Changes in Submitted Information- The Director of NIH shall ensure that updates submitted to the Director under subsections (b)(7) and (c)(4) do not result in the removal from the registry database or the results database of the original submissions or of any preceding updates, and that information in such databases is presented in a manner that enables users to readily access each original submission and to track the changes made by the updates.
`(e) Coordination and Compliance-
`(1) CONSULTATION WITH OTHER FEDERAL AGENCIES- The Secretary shall–
`(A) consult with other agencies that conduct human studies in accordance with part 46 of title 45, Code of Federal Regulations (or any successor regulations), to determine if any such studies are applicable clinical trials; and
`(B) develop with such agencies appropriate procedures to ensure that clinical trial information for such applicable clinical trials is submitted under subsection (b) and (c).
`(2) COORDINATION OF REGISTRY DATABASE AND RESULTS DATABASE-
`(A) IN GENERAL- Each entry in the registry database under subsection (b) or the results database under subsection (c) shall include a link to the corresponding entry in the results database or the registry database, respectively.
`(B) MISSING ENTRIES-
`(i) IN GENERAL- If, based on a review of the entries in the registry database under subsection (b), the Director of NIH determines that a responsible party has failed to submit required clinical trial information to the results database under subsection (c), the Director of NIH shall inform the responsible party involved of such failure and permit the responsible party to correct the failure within 30 days.
`(ii) FAILURE TO CORRECT- If the responsible party does not correct a failure to submit required clinical trial information within the 30-day period described under clause (i), the Director of NIH shall report such noncompliance to the scientific peer review committees of the Federal research agencies and to the Office of Human Research Protections.
`(iii) PUBLIC NOTICE OF FAILURE TO CORRECT- The Director of NIH shall include in the clinical trial registry database entry and the clinical trial results database entry for each applicable clinical trial a notice of any uncorrected failure to submit required clinical trial information and shall provide that the public may easily search for such entries.
`(3) ACTION ON APPLICATIONS-
`(A) VERIFICATION PRIOR TO FILING- The Secretary, acting through the Commissioner of Food and Drugs, shall verify that the clinical trial information required under subsections (b) and (c) for an applicable clinical trial is submitted pursuant to such subsections, as applicable–
`(i) when considering a drug or device for an exemption under section 505(i) or section 520(g) of the Federal Food, Drug, and Cosmetic Act; and
`(ii) prior to filing an application or premarket notification under section 505, 510(k), or 515 of the Federal Food, Drug, and Cosmetic Act or section 351 of this Act, that includes information from such clinical trial.
`(B) NOTIFICATION- If the Secretary determines under subparagraph (A) that clinical trial information has not been submitted as required by subsection (b) or (c), the Secretary shall notify the applicant and the responsible party of such noncompliance and require submission of such information within 30 days.
`(C) REFUSAL TO FILE- If the responsible party does not remedy such noncompliance within 30 days of receipt of notification under subparagraph (B), the Secretary shall refuse to file, approve, or clear such application or premarket notification.
`(4) CONTENT REVIEW-
`(A) IN GENERAL- To ensure that the summary documents described in subsection (c)(3) are non-promotional, and are not false or misleading in any particular under subsection (c)(5), the Secretary shall compare such documents to the results data of the clinical trial for a representative sample of applicable clinical trials by–
`(i) acting through the Commissioner of Food and Drugs to examine the results data for such clinical trials submitted to Secretary when such data are submitted–
`(I) for review as part of an application under section 505 or 515 of the Federal Food, Drug, and Cosmetic Act or under section 351 of this Act or a premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act; or
`(II) in an annual status report on the drug or device under such application;
`(ii) acting with the Federal agency that funds such clinical trial in whole or in part by a grant to examine the results data for such clinical trials; and
`(iii) acting through inspections under section 704 of the Federal Food, Drug, and Cosmetic Act to examine results data for such clinical trials not described in clause (i) or (ii).
`(B) NOTICE OF NONCOMPLIANCE- If the Secretary determines that the clinical trial information submitted in such a summary document is false or misleading in any particular, the Secretary shall notify the responsible party and give such party an opportunity to remedy such noncompliance by submitting the required revised clinical trial information within 30 days of such notification.
`(f) Penalties for Noncompliance-
`(1) IN GENERAL- The following acts and the causing thereof are unlawful:
`(A) The failure to submit clinical trial information as required by this section.
`(B) The submission of clinical trial information under this section that is false or misleading in any particular in violation of subsection (b)(5) or (c)(5).
`(2) CERTAIN PENALTIES- Section 303(a) of the Federal Food, Drug, and Cosmetic Act applies with respect to a violation of paragraph (1) to the same extent and in the same manner as such section 303(a) applies with respect to a violation of section 301 of such Act.
`(3) CONSIDERATIONS- In determining whether to apply a penalty under paragraph (2) or under paragraph (4) for a violation described in paragraph (1), the Secretary, acting through the Commissioner of Food and Drugs, shall consider–
`(A) whether the responsible party promptly corrects the noncompliance when provided notice;
`(B) whether the responsible party has engaged in a pattern or practice of noncompliance; and
`(C) the extent to which the noncompliance involved may have significantly misled health care providers or patients concerning the safety or effectiveness of the drug involved.
`(4) CIVIL PENALTIES-
`(A) IN GENERAL- A person is subject to a civil penalty in accordance with this paragraph if the person commits a violation described in paragraph (1) and fails to correct the violation by the end of the 30-day period described in subparagraph (B).
`(B) NOTIFICATION- If a person is in violation of paragraph (1), the Secretary shall notify the person of such noncompliance and give the person a 30-day period to correct such violation before imposing a civil penalty under this paragraph.
`(C) AMOUNT OF PENALTY- The amount of a civil penalty under this subsection shall be not more than a total of $15,000 for all violations adjudicated in a single proceeding in the case of an individual, and not more than $10,000 per day until the violation is corrected in the case of any other person, except that if the person is a nonprofit entity the penalty may not exceed a total of $15,000 for all violations adjudicated in a single proceeding.
`(D) PROCEDURES- The provisions of paragraphs (4) through (6) of section 303(f) of the Federal Food, Drug, and Cosmetic Act apply to the imposition of a penalty under this subsection to the same extent and in the same manner as such provisions apply to a penalty imposed under such section 303(f).
`(g) Authorization of Appropriations- There are authorized to be appropriated to carry out this section $10,000,000 for each fiscal year.’.
(b) Conforming Amendments-
(1) INVESTIGATIONAL NEW DRUGS- Section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is amended–
(A) in paragraph (1)–
(i) in subparagraph (C), by striking `and’ after the semicolon;
(ii) in subparagraph (D)–
(I) by aligning the indentation of such subparagraph with the indentation of subparagraphs (A), (B), and (C); and
(II) by striking the period at the end and inserting `; and’; and
(iii) by adding at the end the following:
`(E) the submission to the Director of NIH of clinical trial information for the clinical investigation at issue required under section 492C of the Public Health Service Act for inclusion in the registry database and the results database described in such section.’;
(B) in paragraph (3)(B)–
(i) in clause (i), by striking `or’ after the semicolon;
(ii) in clause (ii), by striking the period at the end and inserting `; or’; and
(iii) by adding at the end the following:
`(iii) clinical trial information for the clinical investigation at issue was not submitted in compliance with section 492C of the Public Health Service Act.’; and
(C) in paragraph (4), by adding at the end the following: `The Secretary shall update such regulations to require inclusion in the informed consent form a statement that clinical trial information for such clinical investigation will be submitted for inclusion in the registry database and results database, as applicable, described in section 492C of the Public Health Service Act.’.
(2) REFUSAL TO APPROVE NEW DRUG APPLICATION- Section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) is amended–
(A) in the first sentence, by inserting after `in any particular;’ the following: `or (8) the applicant failed to submit the clinical trial information for any applicable clinical trial as required by section 492C of the Public Health Service Act;’; and
(B) in the second sentence, by striking `clauses (1) through (6)’ and inserting `paragraphs (1) through (8)’.
(3) INVESTIGATIONAL NEW DEVICES- Subparagraph (B) of section 520(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)(2)) is amended–
(A) by redesignating clause (iii) as clause (iv); and
(B) by inserting after clause (ii) the following:
`(iii) A requirement that the person applying for an exemption for a device assure that such person is in compliance with the requirements of section 492C of the Public Health Service Act for the submission of clinical trial information for inclusion in the registry database and the results database described in such section.’.
(4) REFUSAL TO CLEAR NEW DEVICE PREMARKET NOTIFICATION REPORT- Subsection (k) of section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amended–
(A) in paragraph (1), by striking `and’ at the end; and
(B) in paragraph (2), by striking the period at the end and inserting `, and’; and
(C) by adding at the end the following:
`(3) action taken by such person to comply with requirements under section 492C of the Public Health Service Act for the submission of clinical trial information for inclusion in the registry database and the results database described in such section.’.
(5) REFUSAL TO APPROVE NEW DEVICE APPLICATION- Paragraph (2) of section 515(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(d)) is amended–
(A) in subparagraph (D), by striking `or’ at the end;
(B) in subparagraph (E), by striking the period at the end and inserting `; or’; and
(C) by inserting after subparagraph (E) the following:
`(F) the applicant is in violation of the requirements under section 492C of the Public Health Service Act for the submission of clinical trial information for inclusion in the registry database or the results database described in such section.’.
(c) Guidance- Not later than 180 days after the date of the enactment of this Act, the Commissioner of Food and Drugs, in consultation with the Director of the National Institutes of Health, shall issue guidance to clarify which clinical trials are applicable clinical trials (as defined in section 492C of the Public Health Service Act, as amended by this section) and required to be submitted for inclusion in the clinical trial registry database described in such section.
(d) Preemption-
(1) IN GENERAL- No State or political subdivision of a State may establish or continue in effect any requirement for the registration of clinical trials or any requirement for the inclusion of information relating to the results of clinical trials in a database.
(2) RULE OF CONSTRUCTION- The fact of submission of clinical trial information, if submitted in compliance with section 492C of the Public Health Service Act (as amended by this section), that relates to a use of a drug or device not included in the official labeling of the approved drug or device shall not be construed by the Secretary or in any administrative or judicial proceeding, as evidence of a new intended use of the drug or device that is different from the intended use of the drug or device set forth in the official labeling of the drug or device. The availability of clinical trial information through the databases under subsections (b) and (c) of such section 492C, if submitted in compliance with such section 492C, shall not be considered as labeling, adulteration, or misbranding of the drug or device under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(e) Effective Dates-
(1) ESTABLISHMENT OF REGISTRY DATABASE AND RESULTS DATABASE- Not later than 1 year after the date of the enactment of this Act, the Director of NIH shall establish the registry database and the results database of clinical trials of drugs and devices in accordance with section 492C of the Public Health Service Act (as amended by subsection (a)).
(2) CLINICAL TRIALS INITIATED PRIOR TO OPERATION OF REGISTRY DATABASE- The responsible party (as defined in such section 492C) for an applicable clinical trial (as defined in such section 492C) that is initiated after the date of the enactment of this Act and before the date such registry database is established under paragraph (1) of this subsection, shall submit required clinical trial information not later than 120 days after the date such registry database is established.
(3) CLINICAL TRIALS INITIATED AFTER OPERATION OF REGISTRY DATABASE- The responsible party (as defined in such section 492C) for an applicable clinical trial (as defined in such section 492C) that is initiated after the date such registry database is established under paragraph (1) of this subsection shall submit required clinical trial information in accordance with subsection (b) of such section 492C.
(4) TRIALS COMPLETED BEFORE OPERATION OF RESULTS DATABASE-
(A) IN GENERAL- Subsection (c) of such section 492C shall take effect 90 days after the date the results database is established under paragraph (1) of this subsection with respect to any applicable clinical trial (as defined in such section 492C) that–
(i) involves a drug to treat a serious or life-threatening condition; and
(ii) is completed between the date of the enactment of this Act and such date of establishment under paragraph (1) of this subsection.
(B) OTHER TRIALS- Except as provided in subparagraph (A), subsection (c) of such section 492C shall take effect 180 days after the date that the results database is established under paragraph (1) of this subsection with respect to any applicable clinical trial that is completed between the date of the enactment of this Act and such date of establishment under paragraph (1).
(5) TRIALS COMPLETED AFTER ESTABLISHMENT OF RESULTS DATABASE- Subsection (c) of such section 492C shall apply to any clinical trial that is completed after the date that the results database is established under paragraph (1) of this subsection.
(6) RETROACTIVITY OF DATABASE-
(A) VOLUNTARY SUBMISSIONS- The Secretary of Health and Human Services (referred to in this paragraph as the `Secretary’) shall establish procedures and mechanisms to allow for the voluntary submission to the Secretary–
(i) of clinical trial information for inclusion in the registry database (as defined in such section 492C) on applicable clinical trials (as defined in such section 492C) initiated before the date of the enactment of this Act; and
(ii) of clinical trial information for inclusion in the results database (as defined in such section 492C) on applicable clinical trials (as defined in such section 492C) completed before the date of the enactment of this Act.
(B) REQUIRED SUBMISSIONS- Notwithstanding the preceding paragraphs of this subsection, in any case in which the Secretary determines that submission of clinical trial information for an applicable clinical trial (as defined in such section 492C) described in clause (i) or (ii) of subparagraph (A) is in the interest of the public health–
(i) the Secretary may require that such information be submitted to the Secretary in accordance with such section 492C; and
(ii) failure to comply with such a requirement shall be treated as a violation of the corresponding requirement of such section 492C.
(7) STATUS OF CLINICALTRIALS.GOV WEBSITE-
(A) IN GENERAL- After receiving public comment and not later than 90 days after the date of the enactment of this Act, the Secretary shall publish in the Federal Register a notice determining the more efficient approach to establishing the registry database described in subsection (b) of such section 492C and whether such approach is–
(i) that such registry database should expand and build upon the data bank described in section 402(i) of the Public Health Service Act (as in effect on the day before the date of the enactment of this Act); or
(ii) that such registry database should supplant the data bank described in such section 402(i) (as in effect on the day before the date of the enactment of this Act).
(B) CLINICALTRIALS.GOV SUPPLANTED- If the Secretary determines to apply the approach described under subparagraph (A)(ii), the Secretary shall maintain an archive of the data bank described in such section 402(i) (as in effect on the day before the date of the enactment of this Act) on the Internet website of the National Library of Medicine.
SEC. 802. STUDY BY GOVERNMENT ACCOUNTABILITY OFFICE.
(a) In General- The Comptroller General of the United States shall conduct a study to determine whether information on the trials registry and database is considered promotional and to evaluate the implementation of this database.
(b) Report- Not later than one year after the date of the enactment of this Act, the Comptroller General shall complete the study under subsection (a) and submit to the Congress a report on the results of such study.
TITLE IX–ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS
SEC. 901. POSTMARKET STUDIES AND CLINICAL TRIALS REGARDING HUMAN DRUGS; RISK EVALUATION AND MITIGATION STRATEGIES.
(a) In General- Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following subsections:
`(o) Postmarket Studies and Clinical Trials; Labeling-
`(1) IN GENERAL- A responsible person may not introduce or deliver for introduction into interstate commerce the new drug involved if the person is in violation of a requirement established under paragraph (3) or (4) with respect to the drug.
`(2) DEFINITIONS- For purposes of this subsection:
`(A) RESPONSIBLE PERSON- The term `responsible person’ means a person who–
`(i) has submitted to the Secretary a covered application that is pending; or
`(ii) is the holder of an approved covered application.
`(B) COVERED APPLICATION- The term `covered application’ means–
`(i) an application under subsection (b) for a drug that is subject to section 503(b); and
`(ii) an application under section 351 of the Public Health Service Act.
`(C) NEW SAFETY INFORMATION; SERIOUS RISK- The terms `new safety information’, `serious risk’, and `signal of a serious risk’ have the meanings given such terms in section 505-1(b).
`(3) STUDIES AND CLINICAL TRIALS-
`(A) IN GENERAL- For any or all of the purposes specified in subparagraph (B), the Secretary may, subject to subparagraph (C), require a responsible person for a drug to conduct a postapproval study or studies of the drug, or a postapproval clinical trial or trials of the drug, on the basis of scientific information, including information regarding chemically-related or pharmacologically-related drugs.
`(B) PURPOSES OF STUDY OR TRIAL- The purposes referred to in this subparagraph with respect to a postapproval study or postapproval clinical trial are the following:
`(i) To assess a known serious risk related to the use of the drug involved.
`(ii) To assess signals of serious risk related to the use of the drug.
`(iii) To identify a serious risk.
`(C) ESTABLISHMENT OF REQUIREMENT AFTER APPROVAL OF COVERED APPLICATION- The Secretary may require a postapproval study or studies or postapproval trial or trials for a drug for which an approved covered application is in effect as of the date on which the Secretary seeks to establish such requirement only if the Secretary becomes aware of new safety information. For each study required to be conducted under this subparagraph, the Secretary shall require that the applicant submit a timetable for completion of the study and shall require the applicant to periodically report to the Secretary on the status of the study. Unless the applicant demonstrates good cause for failure to comply with such timeline, the applicant shall be in violation of this subsection. The Secretary shall determine what constitutes good cause under the preceding sentence.
`(4) SAFETY LABELING CHANGES REQUESTED BY SECRETARY-
`(A) NEW SAFETY INFORMATION- The Secretary shall promptly notify the responsible person if the Secretary becomes aware of new safety information that the Secretary believes should be included in the labeling of the drug.
`(B) RESPONSE TO NOTIFICATION- Following notification pursuant to subparagraph (A), the responsible person shall within 30 days–
`(i) submit a supplement proposing changes to the approved labeling to reflect the new safety information, including changes to boxed warnings, contraindications, warnings, precautions, or adverse reactions; or
`(ii) notify the Secretary that the responsible person does not believe a labeling change is warranted and submit a statement detailing the reasons why such a change is not warranted.
`(C) REVIEW- Upon receipt of such supplement, the Secretary shall promptly review and act upon such supplement. If the Secretary disagrees with the proposed changes in the supplement or with the statement setting forth the responsible person’s reasons why no labeling change is necessary, the Secretary shall initiate discussions with the responsible person to reach agreement on whether the labeling for the drug should be modified to reflect the new safety information, and if so, the contents of such labeling changes.
`(D) DISCUSSIONS- Such discussions shall not extend for more than 30 days after the response to the notification under subparagraph (B), unless the Secretary determines an extension of such discussion period is warranted.
`(E) ORDER- Within 15 days of the conclusion of the discussions under subparagraph (D), the Secretary may issue an order directing the responsible person to make such a labeling change as the Secretary deems appropriate to address the new safety information. Within 15 days of such an order, the responsible person shall submit a supplement containing the labeling change.
`(F) DISPUTE RESOLUTION- Within 5 days of receiving an order under subparagraph (E), the responsible person may appeal using the Food and Drug Administration’s normal dispute resolution procedures established by the Secretary in regulation and guidance.
`(G) VIOLATION- If the change required by an order under subparagraph (E) is not made by the date so specified, the responsible person shall be considered to be in violation of this section.
`(H) SERIOUS PUBLIC HEALTH THREAT- Notwithstanding subparagraphs (A) through (F), if the Secretary concludes that failure to make such a labeling change is necessary to protect against a serious public health threat, the Secretary may accelerate the timelines in such subparagraphs.
`(I) RULE OF CONSTRUCTION- This paragraph shall not be construed to affect the responsibility of the responsible person to maintain its label in accordance with existing requirements, including subpart B and section 314.70 of title 21, Code of Federal Regulations (or any successor regulations).
`(p) Risk Evaluation and Mitigation Strategy-
`(1) IN GENERAL- A person may not introduce or deliver for introduction into interstate commerce a new drug if–
`(A)(i) the application for such drug is approved under subsection (b) or (j) and is subject to section 503(b); or
`(ii) the application for such drug is approved under section 351 of the Public Health Service Act; and
`(B) a risk evaluation and mitigation strategy is required under section 505-1 with respect to the drug and–
`(i) the person fails to maintain compliance with the requirements of the approved strategy or with other requirements under section 505-1, including requirements regarding assessments of approved strategies; or
`(ii) in the case of a requirement for such a strategy that is first established after the applicable application referred to in subparagraph (A) was approved with respect to the drug, the Secretary, after notice and opportunity for a hearing, publishes in the Federal Register a statement that the person is not cooperating with the Secretary in developing such a strategy for the drug.
`(2) REQUIRED STATEMENT DURING APPROVAL PROCESS- In the case of an application approved under subsection (b) or (j) for a new drug that is subject to section 503(b), or an application approved under section 351 of the Public Health Service Act, or a supplement to such an application that requires substantive data, the Secretary may not approve the application or supplement unless the person involved has complied with the following:
`(A) The person has submitted to the Secretary a statement that provides the following information:
`(i) Whether the person believes that a risk evaluation and mitigation strategy should be required under section 505-1.
`(ii) Whether a postmarket study or clinical trial should be required under subsection (o)(3).
`(B) In making the statement under subparagraph (A), the person took into account each of the following factors:
`(i) The estimated size of the population likely to use the drug involved.
`(ii) The seriousness of the disease or condition that is to be treated with the drug.
`(iii) The expected benefit of the drug with respect to such disease or condition.
`(iv) The expected or actual duration of treatment with the drug.
`(v) The seriousness of any known or potential adverse events that may be related to the drug and the background incidence of such events in the population likely to use the drug.
`(3) CERTAIN POSTMARKET STUDIES- The failure to conduct a postmarket study under subpart H of part 314 of title 21, Code of Federal Regulations (or any successor regulation), is deemed to be a violation of paragraph (1).’.
(b) Requirements Regarding Strategies- Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 505 the following section:
`SEC. 505-1. RISK EVALUATION AND MITIGATION STRATEGIES.
`(a) Submission of Proposed Strategy-
`(1) INITIAL APPROVAL- A person who submits an application referred to in section 505(p)(1)(A) (referred to in this section as a `covered application’) shall submit to the Secretary as part of the application a proposed risk evaluation and mitigation strategy if the Secretary determines such a strategy is necessary to ensure that the benefits of the drug involved outweigh the risks of the drug. In making such a determination, the Secretary shall consider the statement submitted by the person under section 505(p)(2) with respect to the drug and shall consider the following factors:
`(A) The estimated size of the population likely to use the drug involved.
`(B) The seriousness of the disease or condition that is to be treated with the drug.
`(C) The expected benefit of the drug with respect to such disease or condition.
`(D) The expected or actual duration of treatment with the drug.
`(E) The seriousness of any known or potential adverse events that may be related to the drug and the background incidence of such events in the population likely to use the drug.
`(F) The availability and safety of a drug or other treatment, if any, for such disease or condition to which the safety of the drug may be compared.
`(G) Whether the drug is a new molecular entity.
`(2) POSTAPPROVAL REQUIREMENT-
`(A) IN GENERAL- If the Secretary approves a covered application and does not when approving the application require a risk evaluation and mitigation strategy under paragraph (1), the Secretary may subsequently require such a strategy for the drug involved if the Secretary becomes aware of new safety information and makes a determination that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks of the drug.
`(B) SUBMISSION OF PROPOSED STRATEGY- Not later than 120 days after the Secretary notifies the holder of an approved covered application that the Secretary has made a determination under subparagraph (A) with respect to the drug involved, or within such other time as the Secretary requires to protect the public health, the holder shall submit to the Secretary a proposed risk evaluation and mitigation strategy.
`(3) APPROVAL OF NEW INDICATION FOR USE- The applicability of paragraph (2) includes applicability to a drug for which an approved covered application was in effect on the day before the effective date of this section and for which, on or after such effective date, the holder of the approved application submits to the Secretary a supplemental application seeking approval of a new indication for use of the drug.

Section 901 continues here.

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