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HR 2900 continued to end

HR 2900 Key sections to end of bill

`(4) ABBREVIATED NEW DRUG APPLICATIONS- The applicability of this section to an application under section 505(j) is subject to subsection (i).
`(b) Definitions- For purposes of this section:
`(1) ADVERSE DRUG EXPERIENCE- The term `adverse drug experience’ means any adverse event associated with the use of a drug in humans, whether or not considered drug related, including–
`(A) an adverse event occurring in the course of the use of the drug in professional practice;
`(B) an adverse event occurring from an overdose of the drug, whether accidental or intentional;
`(C) an adverse event occurring from abuse of the drug;
`(D) an adverse event occurring from withdrawal of the drug; and
`(E) any failure of expected pharmacological action of the drug.
`(2) COVERED APPLICATION- The term `covered application’ has the meaning indicated for such term in subsection (a)(1).
`(3) NEW SAFETY INFORMATION- The term `new safety information’ with respect to a drug means information about–
`(A) a serious risk or an unexpected serious risk associated with use of the drug that the Secretary has become aware of since the drug was approved, since the risk evaluation and mitigation strategy was required, or since the last assessment of the approved risk evaluation and mitigation strategy for the drug; or
`(B) the effectiveness of the approved risk evaluation and mitigation strategy for the drug obtained since the last assessment of such strategy.
`(4) SERIOUS ADVERSE DRUG EXPERIENCE- The term `serious adverse drug experience’ is an adverse event that–
`(A) results in–
`(i) death;
`(ii) an adverse drug experience that places the patient at immediate risk of death from the adverse drug experience as it occurred (not including an adverse drug experience that might have caused death had it occurred in a more severe form);
`(iii) inpatient hospitalization or prolongation of existing hospitalization;
`(iv) a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; or
`(v) a congenital anomaly or birth defect; or
`(B) based on appropriate medical judgment, may jeopardize the patient and may require a medical or surgical intervention to prevent an outcome described under subparagraph (A).
`(5) SERIOUS RISK- The term `serious risk’ means a risk of a serious adverse drug experience.
`(6) SIGNAL OF A SERIOUS RISK- The term `signal of a serious risk’ means information related to a serious adverse drug experience associated with use of a drug and derived from–
`(A) a clinical trial;
`(B) adverse event reports;
`(C) a postapproval study, including a study under section 505(o)(3);
`(D) peer-reviewed biomedical literature; or
`(E) data derived from a postmarket risk identification and analysis system under section 505(k)(3).
`(7) RESPONSIBLE PERSON- The term `responsible person’ has the meaning indicated for such term in subsection (e)(2).
`(8) UNEXPECTED SERIOUS RISK- The term `unexpected serious risk’ means a serious adverse drug experience that is not listed in the labeling of a drug, or that may be symptomatically and pathophysiologically related to an adverse drug experience identified in the labeling, but differs from such adverse drug experience because of greater severity, specificity, or prevalence.
`(c) Contents- A proposed risk evaluation and mitigation strategy under subsection (a) shall–
`(1) include the timetable required under subsection (d); and
`(2) to the extent required by the Secretary, include additional elements described in subsections (e) and (f).
`(d) Minimal Strategy- For purposes of subsection (c)(1), the risk evaluation and mitigation strategy for a drug shall require a timetable for submission of assessments of the strategy that–
`(1) is not less frequent than once annually for the first 3 years after the strategy is initially approved;
`(2) includes an assessment in the seventh year after the strategy is so approved; and
`(3) subject to paragraph (2), for subsequent years–
`(A) is at a frequency specified in the strategy;
`(B) is increased or reduced in frequency as necessary as provided for in subsection (g)(4)(A); and
`(C) is eliminated after the 3-year period described in paragraph (1) if the Secretary determines that serious risks of the drug have been adequately identified and assessed and are being adequately managed.
`(e) Additional Potential Elements of Strategy-
`(1) IN GENERAL- The Secretary may under subsection (c)(2) require that the risk evaluation and mitigation strategy for a drug include 1 or more of the additional elements described in this subsection if the Secretary makes the determination required with respect to the element involved.
`(2) MEDGUIDE; PATIENT PACKAGE INSERT- The risk evaluation and mitigation strategy for a drug may require that, as applicable, the person submitting the covered application or the holder of the approved such application (referred to in this section as the `responsible person’) develop for distribution to each patient when the drug is dispensed–
`(A) a Medication Guide, as provided for under part 208 of title 21, Code of Federal Regulations (or any successor regulations); and
`(B) a patient package insert, if the Secretary determines that such insert may help mitigate a serious risk of the drug.
`(3) COMMUNICATION PLAN- The risk evaluation and mitigation strategy for a drug may require that the responsible person conduct a communication plan to health care providers, if, with respect to such drug, the Secretary determines that such plan may support implementation of an element of the strategy. Such plan may include–
`(A) sending letters to health care providers;
`(B) disseminating information about the elements of the risk evaluation and mitigation strategy to encourage implementation by health care providers of components that apply to such health care providers, or to explain certain safety protocols (such as medical monitoring by periodic laboratory tests); or
`(C) disseminating information to health care providers through professional societies about any serious risks of the drug and any protocol to assure safe use.
`(f) Restrictions on Distribution or Use-
`(1) IN GENERAL- If the Secretary determines that a drug shown to be effective can be safely used only if distribution or use of such drug is restricted, the Secretary may under subsection (c)(2) require as elements of the risk evaluation and mitigation strategy such restrictions on distribution or use as are needed to ensure safe use of the drug.
`(2) ASSURING ACCESS AND MINIMIZING BURDEN- Elements of a risk evaluation and mitigation strategy included under paragraph (1) shall–
`(A) be commensurate with a specific serious risk listed in the labeling of the drug;
`(B) be posted publicly by the Secretary with an explanation of how such elements will mitigate the observed safety risk, which posting shall be made within 30 days after the date on which the Secretary requires the element involved;
`(C) considering the risk referred to in subparagraph (A), not be unduly burdensome on patient access to the drug, considering in particular–
`(i) patients with serious or life-threatening diseases or conditions; and
`(ii) patients who have difficulty accessing health care (such as patients in rural or medically underserved areas); and
`(D) to the extent practicable, so as to minimize the burden on the health care delivery system–
`(i) conform with elements to assure safe use for other drugs with similar, serious risks; and
`(ii) be designed to be compatible with established distribution, procurement, and dispensing systems for drugs.
`(3) ELEMENTS- The restrictions on distribution or use described in paragraph (1) shall include 1 or more goals to evaluate or mitigate a serious risk listed in the labeling of the drug, and may require that–
`(A) health care providers that prescribe the drug have special training or experience, or are specially certified, which training or certification with respect to the drug is available to any willing provider from a frontier area;
`(B) pharmacies, practitioners, or health care settings that dispense the drug are specially certified, which training or certification with respect to the drug is available to any willing provider from a frontier area;
`(C) the drug be dispensed to patients only in certain health care settings, such as hospitals;
`(D) the drug be dispensed to patients with evidence or other documentation of safe-use conditions, such as laboratory test results;
`(E) each patient using the drug be subject to certain monitoring; or
`(F) each patient using the drug be enrolled in a registry.
`(4) IMPLEMENTATION SYSTEM- The restrictions on distribution or use described in paragraph (1) may require a system through which the responsible person is able to–
`(A) monitor and evaluate implementation of the restrictions by health care providers, pharmacists, patients, and other parties in the health care system who are responsible for implementing the restrictions;
`(B) work to improve implementation of the restrictions by health care providers, pharmacists, patients, and other parties in the health care system who are responsible for implementing the restrictions; and
`(C) notify wholesalers of the drug of those health care providers–
`(i) who are responsible for implementing the restrictions; and
`(ii) whom the responsible person knows have failed to meet their responsibilities for implementing the restrictions, after the responsible person has informed such party of such failure and such party has not remedied such failure.
`(5) LIMITATION- No holder of an approved application shall use any restriction on distribution required by the Secretary as necessary to assure safe use of the drug to block or delay approval of an application under section 505(b)(2) or (j) or to prevent application of such restriction under subsection (i)(1)(B) to a drug that is the subject of an abbreviated new drug application.
`(6) BIOEQUIVALENCE TESTING- Notwithstanding any other provisions in this subsection, the holder of an approved application that is subject to distribution restrictions required under this subsection that limit the ability of a sponsor seeking approval of an application under subsection 505(b)(2) or (j) to purchase on the open market a sufficient quantity of drug to conduct bioequivalence testing shall provide to such a sponsor a sufficient amount of drug to conduct bioequivalence testing if the sponsor seeking approval under section 505(b)(2) or (j)–
`(A) agrees to such restrictions on distribution as the Secretary finds necessary to assure safe use of the drug during bioequivalence testing; and
`(B) pays the holder of the approved application the fair market value of the drug purchased for bioequivalence testing.
`(7) LETTER BY SECRETARY- Upon a showing by the sponsor seeking approval under section 505(b)(2) or (j) that the sponsor has agreed to such restrictions necessary to assure safe use of the drug during bioequivalence testing, the Secretary shall issue to the sponsor seeking to conduct bioequivalence testing a letter that describes the Secretary’s finding which shall serve as proof that the sponsor has satisfied the requirements of subparagraph (6)(A).
`(8) EVALUATION OF ELEMENTS TO ASSURE SAFE USE- The Secretary, acting through the Drug Safety and Risk Management Advisory Committee (or any successor committee) of the Food and Drug Administration, shall–
`(A) seek input from patients, physicians, pharmacists, and other health care providers about how elements to assure safe use under this subsection for 1 or more drugs may be standardized so as not to be–
`(i) unduly burdensome on patient access to the drug; and
`(ii) to the extent practicable, minimize the burden on the health care delivery system;
`(B) at least annually, evaluate, for 1 or more drugs, the elements to assure safe use of such drug to assess whether the elements–
`(i) assure safe use of the drug;
`(ii) are not unduly burdensome on patient access to the drug; and
`(iii) to the extent practicable, minimize the burden on the health care delivery system; and
`(C) considering such input and evaluations–
`(i) issue or modify agency guidance about how to implement the requirements of this subsection; and
`(ii) modify elements under this subsection for 1 or more drugs as appropriate.
`(9) WAIVER IN PUBLIC HEALTH EMERGENCIES- The Secretary may waive any restriction on distribution or use under this subsection during the period described in section 319(a) of the Public Health Service Act with respect to a qualified countermeasure described under section 319F-1(a)(2) of such Act, to which a restriction or use under this subsection has been applied, if the Secretary has–
`(A) declared a public health emergency under such section 319; and
`(B) determined that such waiver is required to mitigate the effects of, or reduce the severity of, such public health emergency.
`(g) Assessment and Modification of Approved Strategy-
`(1) VOLUNTARY ASSESSMENTS- After the approval of a risk evaluation and mitigation strategy under subsection (a), the responsible person involved may, subject to paragraph (2), submit to the Secretary an assessment of, and propose a modification to, the approved strategy for the drug involved at any time.
`(2) REQUIRED ASSESSMENTS- A responsible person shall, subject to paragraph (5), submit an assessment of, and may propose a modification to, the approved risk evaluation and mitigation strategy for a drug–
`(A) when submitting a supplemental application for a new indication for use under section 505(b) or under section 351 of the Public Health Service Act, unless the drug is not subject to section 503(b) and the risk evaluation and mitigation strategy for the drug includes only the timetable under subsection (d);
`(B) when required by the strategy, as provided for in such timetable under subsection (d);
`(C) within a time period to be determined by the Secretary, if the Secretary determines that new safety or effectiveness information indicates that–
`(i) an element under subsection (d) or (e) should be modified or included in the strategy; or
`(ii) an element under subsection (f) should be modified or included in the strategy; or
`(D) within 15 days when ordered by the Secretary, if the Secretary determines that there may be a cause for action by the Secretary under section 505(e).
`(3) REQUIREMENTS FOR ASSESSMENTS- An assessment under paragraph (1) or (2) of an approved risk evaluation and mitigation strategy for a drug shall include–
`(A) with respect to any goal under subsection (f), an assessment of the extent to which the restrictions on distribution or use are meeting the goal or whether the goal or such restrictions should be modified;
`(B) with respect to any postapproval study required under section 505(o)(3), the status of such study, including whether any difficulties completing the study have been encountered; and
`(C) with respect to any postapproval clinical trial required under section 505(o), the status of such clinical trial, including whether enrollment has begun, the number of participants enrolled, the expected completion date, whether any difficulties completing the clinical trial have been encountered, and registration information with respect to requirements under section 492C of the Public Health Service Act.
`(4) MODIFICATION- A modification (whether an enhancement or a reduction) to the approved risk evaluation and mitigation strategy for a drug may include the addition or modification of any element under subsection (d) or the addition, modification, or removal of any element under subsection (e) or (f), such as–
`(A) modifying the timetable for assessments of the strategy under subsection (d), including to eliminate assessments; or
`(B) adding, modifying, or removing a restriction on distribution or use under subsection (f).
`(5) NO EFFECT ON LABELING CHANGES THAT DO NOT REQUIRE PREAPPROVAL- In the case of a labeling change to which section 314.70 of title 21, Code of Federal Regulations (or any successor regulation), applies for which the submission of a supplemental application is not required or for which distribution of the drug involved may commence upon the receipt by the Secretary of a supplemental application for the change, the submission of an assessment of the approved risk evaluation and mitigation strategy for the drug under paragraph (2) is not required.
`(h) Review of Proposed Strategies; Review of Assessments of Approved Strategies-
`(1) IN GENERAL- The Secretary shall promptly review each proposed risk evaluation and mitigation strategy for a drug submitted under subsection (a) and each assessment of an approved risk evaluation and mitigation strategy for a drug submitted under subsection (g).
`(2) MARKETING PLAN- As part of a review conducted under this subsection, the Secretary may require the applicant to submit information regarding its marketing plan and practices for the drug, so as to allow the Secretary to determine whether any of the proposed or ongoing marketing activities undermine any of the requirements of the risk evaluation and mitigation strategy.
`(3) DISCUSSION- The Secretary shall initiate discussions with a responsible person for purposes of this subsection to determine a strategy–
`(A) if the proposed strategy is submitted as part of an application or supplemental application under subsection (a) or subsection (g)(2)(A), not less than 60 days before the action deadline for the application that has been agreed to by the Secretary and that has been set forth in goals identified in letters of the Secretary (relating to the use of fees collected under section 736 to expedite the drug development process and the process for the review of human drug applications);
`(B) if the assessment is submitted under subparagraph (B) or (C) or subsection (g)(2), not later than 20 days after such submission;
`(C) if the assessment is submitted under subsection (g)(1) or subsection (g)(2)(D) , not later than 30 days after such submission; or
`(D) if the assessment is submitted under subsection (g)(2)(D), not later than 10 days after such submission.
`(4) ACTION-
`(A) IN GENERAL- Unless the responsible person requests the dispute resolution process described under paragraph (5), the Secretary shall approve and describe the risk evaluation and mitigation strategy for a drug, or any modification to the strategy–
`(i) as part of the action letter on the application, when a proposed strategy is submitted under subsection (a) or an assessment of the strategy is submitted under subsection (g)(1); or
`(ii) in an order issued not later than 50 days after the date discussions of such modification begin under paragraph (3), when an assessment of the strategy is submitted under subsection (g)(1) or under any of subparagraphs (B) through (D) of subsection (g)(2).
`(B) INACTION- An approved risk evaluation and mitigation strategy shall remain in effect until the Secretary acts, if the Secretary fails to act as provided under subparagraph (A).
`(C) PUBLIC AVAILABILITY- Any action letter described in subparagraph (A)(i) or order described in subparagraph (A)(ii) shall be made publicly available.
`(5) DISPUTE RESOLUTION-
`(A) REQUEST FOR REVIEW-
`(i) IN GENERAL- Not earlier than 15 days, and not later than 35 days, after discussions under paragraph (3) have begun, the responsible person may request in writing that a dispute about the strategy be reviewed by the Drug Safety Oversight Board under subsection (j), except that the determination of the Secretary to require a risk evaluation and mitigation strategy is not subject to review under this paragraph. The preceding sentence does not prohibit review under this paragraph of the particular elements of such a strategy.
`(ii) SCHEDULING- Upon receipt of a request under clause (i), the Secretary shall schedule the dispute involved for review under subparagraph (B) and, not later than 5 business days of scheduling the dispute for review, shall publish by posting on the Internet or otherwise a notice that the dispute will be reviewed by the Drug Safety Oversight Board.
`(B) SCHEDULING REVIEW- If a responsible person requests review under subparagraph (A), the Secretary–
`(i) shall schedule the dispute for review at 1 of the next 2 regular meetings of the Drug Safety Oversight Board, whichever meeting date is more practicable; or
`(ii) may convene a special meeting of the Drug Safety Oversight Board to review the matter more promptly, including to meet an action deadline on an application (including a supplemental application).
`(C) AGREEMENT AFTER DISCUSSION OR ADMINISTRATIVE APPEALS-
`(i) FURTHER DISCUSSION OR ADMINISTRATIVE APPEALS- A request for review under subparagraph (A) shall not preclude further discussions to reach agreement on the risk evaluation and mitigation strategy, and such a request shall not preclude the use of administrative appeals within the Food and Drug Administration to reach agreement on the strategy, including appeals as described in letters of the Secretary (relating to the use of fees collected under section 736 to expedite the drug development process and the process for the review of human drug applications) for procedural or scientific matters involving the review of human drug applications and supplemental applications that cannot be resolved at the divisional level.
`(ii) AGREEMENT TERMINATES DISPUTE RESOLUTION- At any time before a decision and order is issued under subparagraph (G) , the Secretary and the responsible person may reach an agreement on the risk evaluation and mitigation strategy through further discussion or administrative appeals, terminating the dispute resolution process, and the Secretary shall issue an action letter or order, as appropriate, that describes the strategy.
`(D) MEETING OF THE BOARD- At a meeting of the Drug Safety Oversight Board described in subparagraph (B), the Board shall–
`(i) hear from both parties; and
`(ii) review the dispute.
`(E) RECORD OF PROCEEDINGS- The Secretary shall ensure that the proceedings of any such meeting are recorded, transcribed, and made public within 30 days of the meeting. The Secretary shall redact the transcript to protect any trade secrets or other confidential information described in section 552(b)(4) of title 5, United States Code.
`(F) RECOMMENDATION OF THE BOARD- Not later than 5 days after any such meeting, the Drug Safety Oversight Board shall provide a written recommendation on resolving the dispute to the Secretary. Not later than 5 days after the Board provides such written recommendation to the Secretary, the Secretary shall make the recommendation available to the public.
`(G) ACTION BY THE SECRETARY-
`(i) ACTION LETTER- With respect to a proposal or assessment referred to in paragraph (1), the Secretary shall issue an action letter that resolves the dispute not later than the later of–
`(I) the action deadline referred to in paragraph (3)(A); or
`(II) 7 days after receiving the recommendation of the Drug Safety Oversight Board.
`(ii) ORDER- With respect to an assessment of an approved risk evaluation and mitigation strategy under subsection (g)(1) or under any of subparagraphs (B) through (D) of subsection (g)(2), the Secretary shall issue an order, which shall be made public, that resolves the dispute not later than 7 days after receiving the recommendation of the Drug Safety Oversight Board.
`(H) INACTION- An approved risk evaluation and mitigation strategy shall remain in effect until the Secretary acts, if the Secretary fails to act as provided for under subparagraph (G).
`(I) EFFECT ON ACTION DEADLINE- With respect to a proposal or assessment referred to in paragraph (1), the Secretary shall be considered to have met the action deadline referred to in paragraph (3)(A) with respect to the application involved if the responsible person requests the dispute resolution process described in this paragraph and if the Secretary–
`(i) has initiated the discussions described under paragraph (3) not less than 60 days before such action deadline; and
`(ii) has complied with the timing requirements of scheduling review by the Drug Safety Oversight Board, providing a written recommendation, and issuing an action letter under subparagraphs (B), (F), and (G), respectively.
`(J) DISQUALIFICATION- No individual who is an employee of the Food and Drug Administration and who reviews a drug or who participated in an administrative appeal under subparagraph (C)(i) with respect to such drug may serve on the Drug Safety Oversight Board at a meeting under subparagraph (D) to review a dispute about the risk evaluation and mitigation strategy for such drug.
`(K) ADDITIONAL EXPERTISE- The Drug Safety Oversight Board may add members with relevant expertise from the Food and Drug Administration, including the Office of Pediatrics, the Office of Women’s Health, or the Office of Rare Diseases, or from other Federal public health or health care agencies, for a meeting under subparagraph (D) of the Drug Safety Oversight Board.
`(6) USE OF ADVISORY COMMITTEES- The Secretary may convene a meeting of 1 or more advisory committees of the Food and Drug Administration to–
`(A) review a concern about the safety of a drug or class of drugs, including before an assessment of the risk evaluation and mitigation strategy or strategies of such drug or drugs is required to be submitted under any of subparagraphs (B) through (D) of subsection (g)(2);
`(B) review the risk evaluation and mitigation strategy or strategies of a drug or group of drugs; or
`(C) review a dispute under paragraph (5).
`(7) PROCESS FOR ADDRESSING DRUG CLASS EFFECTS-
`(A) IN GENERAL- When a concern about a serious risk of a drug may be related to the pharmacological class of the drug, the Secretary may defer assessments of the approved risk evaluation and mitigation strategies for such drugs until the Secretary has convened 1 or more public meetings to consider possible responses to such concern. If the Secretary defers an assessment under this subparagraph, the Secretary shall give notice to the public of the deferral not later than 5 days of the deferral.
`(B) PUBLIC MEETINGS- Such public meetings may include–
`(i) 1 or more meetings of the reviewed entities for such drugs;
`(ii) 1 or more meetings of 1 or more advisory committees of the Food and Drug Administration, as provided for under paragraph (6); or
`(iii) 1 or more workshops of scientific experts and other stakeholders.
`(C) ACTION- After considering the discussions from any meetings under subparagraph (B), the Secretary may–
`(i) announce in the Federal Register a planned regulatory action, including a modification to each risk evaluation and mitigation strategy, for drugs in the pharmacological class;
`(ii) seek public comment about such action; and
`(iii) after seeking such comment, issue an order addressing such regulatory action.
`(8) INTERNATIONAL COORDINATION- The Secretary may coordinate the timetable for submission of assessments under subsection (d), or a study or clinical trial under section 505(o)(3), with efforts to identify and assess the serious risks of such drug by the marketing authorities of other countries whose drug approval and risk management processes the Secretary deems comparable to the drug approval and risk management processes of the United States. If the Secretary takes action to coordinate such timetable, the Secretary shall give notice to the public of the action not later than 5 days after the action.
`(9) EFFECT- Use of the processes described in paragraphs (7) and (8) shall not delay action on an application or a supplement to an application for a drug.
`(i) Abbreviated New Drug Applications-
`(1) IN GENERAL- A drug that is the subject of an abbreviated new drug application under section 505(j) is subject to only the following elements of the risk evaluation and mitigation strategy required under subsection (a) for the applicable listed drug:
`(A) A Medication Guide or patient package insert, if required under subsection (e) for the applicable listed drug.
`(B) Restrictions on distribution or use, if required under subsection (f) for the listed drug. A drug that is the subject of an abbreviated new drug application and the listed drug shall use a single, shared system under subsection (f)(4). The Secretary may waive the requirement under the preceding sentence for a drug that is the subject of an abbreviated new drug application if the Secretary determines that–
`(i) it is not practical for the drug to use such single, shared system; or
`(ii) the burden of using the single, shared system outweighs the benefit of using the single system.
`(2) ACTION BY SECRETARY- For an applicable listed drug for which a drug is approved under section 505(j), the Secretary–
`(A) shall undertake any communication plan to health care providers required under subsection (e)(3) for the applicable listed drug; and
`(B) shall inform the responsible person for the drug that is so approved if the risk evaluation and mitigation strategy for the applicable listed drug is modified.
`(j) Drug Safety Oversight Board-
`(1) IN GENERAL- There is established a Drug Safety Oversight Board.
`(2) COMPOSITION; MEETINGS- The Drug Safety Oversight Board shall–
`(A) be composed of scientists and health care practitioners appointed by the Secretary, each of whom is an employee of the Federal Government;
`(B) include representatives from offices throughout the Food and Drug Administration;
`(C) include at least 1 representative from each of the National Institutes of Health and the Department of Health and Human Services (other than the Food and Drug Administration);
`(D) include such representatives as the Secretary shall designate from other appropriate agencies that wish to provide representatives; and
`(E) meet at least monthly to provide oversight and advice to the Secretary on the management of important drug safety issues.’.
(c) Regulation of Biological Products- Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended–
(1) in subsection (a)(2), by adding at the end the following:
`(D) Risk Evaluation and Mitigation Strategy- A person that submits an application for a license under this paragraph is subject to section 505(p) of the Federal Food, Drug, and Cosmetic Act.’; and
(2) in subsection (j), by inserting `, including the requirements under section 505(p) of such Act,’ after `, and Cosmetic Act’.
(d) Prereview of Advertisements-
(1) SENSE OF CONGRESS- It is the sense of the Congress that–
(A) `Guidance for Industry Consumer-Directed Broadcast Advertisements’ issued by the Food and Drug Administration in August, 1999, represents generally good guidance for direct-to-consumer (DTC) advertising of prescription medicines and other treatments;
(B) direct-to-consumer advertising as an accurate source of health information for all populations, specifically including the elderly populations, children, chronically ill and racial and ethnic minority populations, should be made more reliable by ensuring the truth and credibility of information provided through such advertising; and
(C) the Congress will work with the Food and Drug Administration to ensure that information provided through direct-to-consumer advertising of prescription medicines and other treatments is not false or misleading and communicates clearly and sensitively to all communities.
(2) PREREVIEW- The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended–
(A) in section 301 (21 U.S.C. 331), by adding at the end the following:
`(jj) The dissemination of a television advertisement without complying with section 503B.’; and
(B) by inserting after section 503A the following:
`SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS.
`(a) In General- The Secretary may require the submission of any television advertisement for a drug (including any script, story board, rough, or a completed video production of the television advertisement) to the Secretary for review under this section not later than 45 days before dissemination of the television advertisement.
`(b) Review- In conducting a review of a television advertisement under this section, the Secretary may make recommendations–
`(1) on changes that are–
`(A) necessary to protect the consumer good and well-being; or
`(B) consistent with prescribing information for the product under review; and
`(2) if appropriate and if information exists, on statements for inclusion in the advertisement to address the specific efficacy of the drug as it relates to a specific population group, including elderly populations, children, and racially and ethnically diverse populations.
`(c) No Authority To Require Changes- This section does not authorize the Secretary to make or direct changes in any material submitted pursuant to subsection (a).
`(d) Elderly Populations, Children, Racially and Ethnically Diverse Communities- In formulating recommendations under subsection (b), the Secretary shall take into consideration the impact of the advertised drug on elderly populations, children, and racially and ethnically diverse communities.
`(e) Specific Disclosures-
`(1) SERIOUS RISK; SAFETY PROTOCOL- In conducting a review of a television advertisement under this section, if the Secretary determines that the advertisement would be false or misleading without a specific disclosure about a serious risk listed in the labeling of the drug involved, the Secretary may require inclusion of such disclosure in the advertisement.
`(2) DATE OF APPROVAL- In conducting a review of a television advertisement under this section, the Secretary may require the advertisement to include, for a period not to exceed 2 years from the date of the approval of the drug under section 505, a specific disclosure of such date of approval if the Secretary determines that the advertisement would otherwise be false or misleading.
`(f) Rule of Construction- Nothing in this section may be construed as having any effect on the authority of the Secretary under section 314.550, 314.640, 601.45, or 601.94 of title 21, Code of Federal Regulations (or successor regulations).’.
(3) DIRECT-TO-CONSUMER ADVERTISEMENTS-
(A) IN GENERAL- Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended by adding at the end the following: `In the case of an advertisement for a drug subject to section 503(b)(1) presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications shall be presented in a clear and conspicuous manner.’.
(B) REGULATIONS TO DETERMINE CLEAR AND CONSPICUOUS MANNER- The Secretary of Health and Human Services shall by regulation establish standards for determining whether a major statement relating to side effects and contraindications of a drug, described in section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) (as amended by subparagraph (A)) is presented in the manner required under such section.
(4) CIVIL PENALTIES- Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended–
(A) by redesignating subsection (g) (relating to civil penalties) as subsection (f); and
(B) by adding at the end the following:
`(g)(1) With respect to a person who is a holder of an approved application under section 505 for a drug subject to section 503(b) or under section 351 of the Public Health Service Act, any such person who disseminates a direct-to-consumer advertisement that is false or misleading shall be liable to the United States for a civil penalty in an amount not to exceed $250,000 for the first such violation in any 3-year period, and not to exceed $500,000 for each subsequent violation in any 3-year period. No other civil monetary penalties in this Act (including the civil penalty in section 303(f)(3)) shall apply to a violation regarding direct-to-consumer advertising. For purposes of this paragraph: (A) Repeated dissemination of the same or similar advertisement prior to the receipt of the written notice referred to in paragraph (2) for such advertisements shall be considered one violation. (B) On and after the date of the receipt of such a notice, all violations under this paragraph occurring in a single day shall be considered one violation
`(2) A civil penalty under paragraph (1) shall be assessed by the Secretary by an order made on the record after providing written notice to the person to be assessed a civil penalty and an opportunity for a hearing in accordance with this paragraph and section 554 of title 5, United States Code. If upon receipt of the written notice, the person to be assessed a civil penalty objects and requests a hearing, then in the course of any investigation related to such hearing, the Secretary may issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation, including information pertaining to the factors described in paragraph (3).
`(3) Upon the request of the person to be assessed a civil penalty under paragraph (1), the Secretary, in determining the amount of the civil penalty, shall take into account the nature, circumstances, extent, and gravity of the violation or violations, including the following factors:
`(A) Whether the person submitted the advertisement or a similar advertisement for review under section 736A.
`(B) Whether the person submitted the advertisement for review if required under section 503B.
`(C) Whether, after submission of the advertisement as described in subparagraph (A) or (B), the person disseminated the advertisement before the end of the 45-day comment period.
`(D) Whether the person incorporated any comments made by the Secretary with regard to the advertisement into the advertisement prior to its dissemination.
`(E) Whether the person ceased distribution of the advertisement upon receipt of the written notice referred to in paragraph (2) for such advertisement.
`(F) Whether the person had the advertisement reviewed by qualified medical, regulatory, and legal reviewers prior to its dissemination.
`(G) Whether the violations were material.
`(H) Whether the person who created the advertisement acted in good faith.
`(I) Whether the person who created the advertisement has been assessed a civil penalty under this provision within the previous 1-year period.
`(J) The scope and extent of any voluntary, subsequent remedial action by the person.
`(K) Such other matters, as justice may require.
`(4)(A) Subject to subparagraph (B), no person shall be required to pay a civil penalty under paragraph (1) if the person submitted the advertisement to the Secretary and disseminated such advertisement after incorporating any comment received from the Secretary other than a recommendation subject to subsection 503B(c).
`(B) The Secretary may retract or modify any prior comments the Secretary has provided to an advertisement submitted to the Secretary based on new information or changed circumstances, so long as the Secretary provides written notice to the person of the new views of the Secretary on the advertisement and provides a reasonable time for modification or correction of the advertisement prior to seeking any civil penalty under paragraph (1).
`(5) The Secretary may compromise, modify, or remit, with or without conditions, any civil penalty which may be assessed under paragraph (1). The amount of such penalty, when finally determined, or the amount charged upon in compromise, may be deducted from any sums owed by the United States to the person charged.
`(6) Any person who requested, in accordance with paragraph (2), a hearing with respect to the assessment of a civil penalty and who is aggrieved by an order assessing a civil penalty, may file a petition for de novo judicial review of such order with the United States Court of Appeals for the District of Columbia Circuit or for any other circuit in which such person resides or transacts business. Such a petition may only be filed within the 60-day period beginning on the date the order making such assessments was issued.
`(7) On an annual basis, the Secretary shall report to the Congress on direct-to-consumer advertising and its ability to communicate to subsets of the general population, including elderly populations, children, and racial and ethnic minority communities. The Secretary shall establish a permanent advisory committee to advise the Secretary with respect to such report. The membership of the advisory committee shall consist of nationally recognized medical, advertising, and communications experts, including experts representing subsets of the general population. The members of the advisory committee shall serve without pay, but may receive travel expenses, including per diem in lieu of subsistence in accordance with applicable provisions under subchapter I of chapter 57 of title 5, United States Code. The advisory committee shall study direct-to-consumer advertising as it relates to increased access to health information and decreased health disparities for these populations. The annual report required by this paragraph shall recommend effective ways to present and disseminate information to these populations. Such report shall also make recommendations regarding impediments to the participation of elderly populations, children, racially and ethnically diverse communities, and medically underserved populations in clinical drug trials and shall recommend best practice approaches for increasing the inclusion of such subsets of the general population. The Secretary shall submit the first annual report under this paragraph to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives not later than 18 months after the advisory committee has been convened by the Secretary.
`(8) If any person fails to pay an assessment of a civil penalty under paragraph (1)–
`(A) after the order making the assessment becomes final, and if such person does not file a petition for judicial review of the order in accordance with paragraph (6), or
`(B) after a court in an action brought under paragraph (6) has entered a final judgment in favor of the Secretary,
the Attorney General of the United States shall recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of the 60-day period referred to in paragraph (6) or the date of such final judgment, as the case may be) in an action brought in any appropriate district court of the United States. In such an action, the validity, amount, and appropriateness of such penalty shall not be subject to review.’.
(e) Rule of Construction Regarding Pediatric Studies- This title and the amendments made by this title may not be construed as affecting the authority of the Secretary of Health and Human Services to request pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act or to require such studies under section 505B of such Act.
SEC. 902. ENFORCEMENT.
(a) Misbranding- Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following:
`(y) If it is a drug subject to an approved risk evaluation and mitigation strategy pursuant to section 505(p) and the person responsible for complying with the strategy fails to comply with a requirement of such strategy provided for under subsection (d), (e), or (f) of section 505-1.
`(z) If it is a drug, and the responsible person (as such term is used in section 505(o)) is in violation of a requirement established under paragraph (3) (relating to postmarket studies and clinical trials) or paragraph (4) (relating to labeling) of section 505(o) with respect to such drug.’.
(b) Civil Penalties- Section 303(f) of the Federal Food, Drug, and Cosmetic Act, as redesignated by section 901(d)(4), is amended–
(1) by redesignating paragraphs (3), (4), and (5) as paragraphs (4), (5), and (6), respectively;
(2) by inserting after paragraph (2) the following:
`(3) Any applicant (as such term is used in section 505-1) who violates a requirement of section 505(o), section 505(p), or section 505-1 shall be subject to a civil monetary penalty of–
`(A) not more than $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or
`(B) in the case of a violation that continues after the Secretary provides notice of such violation to the applicant, not more than $10,000,000 per violation, and not to exceed $50,000,000 for all such violations adjudicated in a single proceeding.
If a violation referred to in subparagraph (A) or (B) is continuing in nature and poses a substantial threat to the public health, the Secretary may impose a civil penalty not to exceed $1,000,000 per day during such time period such person is in violation.’;
(3) in paragraph (2)(C), by striking `paragraph (3)(A)’ and inserting `paragraph (4)(A)’;
(4) in paragraph (4), as so redesignated, by striking `paragraph (1) or (2)’ each place it appears and inserting `paragraph (1), (2), or (3)’; and
(5) in paragraph (6), as so redesignated, by striking `paragraph (4)’ each place it appears and inserting `paragraph (5)’.
SEC. 903. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL.
Section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) is amended by adding at the end the following: `The Secretary may withdraw the approval of an application submitted under this section, or suspend the approval of such an application, as provided under this subsection, without first ordering the applicant to submit an assessment of the approved risk evaluation and mitigation strategy for the drug under section 505-1(g)(2)(D).’.
SEC. 904. BENEFIT-RISK ASSESSMENTS.
Not later than 1 year after the date of the enactment of this Act, the Commissioner of Food and Drugs shall submit to the Congress a report on how best to communicate to the public the risks and benefits of new drugs and the role of the risk evaluation and mitigation strategy in assessing such risks and benefits. As part of such study, the Commissioner shall consider the possibility of including in the labeling and any direct-to-consumer advertisements of a newly approved drug or indication a unique symbol indicating the newly approved status of the drug or indication for a period after approval.
SEC. 905. POSTMARKET RISK IDENTIFICATION AND ANALYSIS SYSTEM FOR ACTIVE SURVEILLANCE AND ASSESSMENT.
(a) Findings- Congress finds the following:
(1) It is in the best interests of healthcare providers and patients that a postmarketing surveillance system be developed that will enable active surveillance of disparate sources of data to identify signals of unexpected adverse events and trends in the frequency of known adverse events, to provide data on the outcomes of off label uses, and to enable identification of safety issues earlier than can be done today.
(2) Such a system can best be developed through public private partnerships to develop methods and tools for conducting surveillance using electronic databases that currently contain data on millions of patient encounters and are expected to grow significantly in the next decade, as well as electronic databases that contain millions of medical product purchases, health care claims, and similar information relevant to product use, efficacy, and safety.
(3) Therefore, this section directs the Secretary of Health and Human Services to enter into such public private partnerships as are necessary to develop such a surveillance system and the tools and methods necessary to conduct active surveillance using the system.
(b) Development of the Postmarket Risk Identification and Analysis System- Subsection (k) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:
`(3) The Secretary shall establish public private partnerships to develop tools and methods to enable the Secretary and others to use available electronic databases to create a robust surveillance system that will support active surveillance on important drug safety questions including detecting and assessing drug safety signals; monitoring the frequency of known adverse events; and evaluating the outcomes of off label uses. Such surveillance shall provide for adverse event surveillance using the following data sources:
`(A) Federal health-related electronic data (such as data from the Medicare program and the health systems of the Department of Veterans Affairs).
`(B) Private sector health-related electronic data (such as pharmaceutical purchase data and health insurance claims data).
`(C) Other information as the Secretary deems useful to create a robust system to identify and assess adverse events and potential drug safety signals and to evaluate the extent and outcomes of off label uses of drugs.
`(4) Not later than 1 year after the date of the enactment of this paragraph, the Secretary, in consultation with experts including individuals who are recognized in the field of data privacy and security, shall develop methods for integrating and analyzing safety data from multiple sources and mechanisms for obtaining access to such data. Such methods and mechanisms shall not compromise the protection of individually identifiable health information.
`(5) Not later than 2 years after the date of the enactment of this paragraph, the Secretary shall have entered into partnerships that will allow the analysis of available data from the various data sources using the standards and methods to identify drug safety signals and trends. Such analysis shall not disclose individually identifiable health information when presenting such drug safety signals and trends or when responding to inquiries regarding such drug safety signals and trends.
`(6) Not later than 4 years after the date of the enactment of this paragraph, the Secretary shall report to the Congress on the ways in which the Secretary has used the surveillance system described in this subsection to identify specific drug safety signals and to better understand the outcomes associated with drugs marketed in the United States.
`(7) Disclosure of individually identifiable information is prohibited in the surveillance system described in this subsection. Nothing in this subsection prohibits lawful disclosure of such information for other purposes.
`(8) Nothing in this subsection shall be construed as limiting public health activities authorized under law.’.
(c) Authorization of Appropriations- To carry out activities under the amendment made by subsection (b) for which funds are made available under section 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h), there are authorized to be appropriated, in addition to such funds, $25,000,000 for each of fiscal years 2008 through 2012.
(d) GAO Report- Not later than 18 months after the date of the enactment of this Act, the Comptroller General of the United States shall evaluate data confidentiality and security issues relating to collection, transmission, and maintenance of data for the surveillance system developed pursuant to this section, and make recommendations to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate, and any other congressional committees of relevant jurisdiction, regarding the need for any additional legislative or regulatory actions to ensure confidentiality and security of this data or otherwise address confidentiality and security issues to ensure the effective operation of the surveillance system.
SEC. 907. STATEMENT FOR INCLUSION IN DIRECT-TO-CONSUMER ADVERTISEMENTS OF DRUGS.
Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352), as amended by section 901(d)(3), is further amended by striking `of this Act, except that’ and inserting `of this Act, and in the case of any direct-to-consumer advertisement the following statement: `You are encouraged to report adverse effects of prescription drug medication to the FDA. Log onto www.fda.gov/medwatch or call 1-800-FDA-1088.’, except that’.
SEC. 908. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 510 the following:
`SEC. 511. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS.
`(a) In General- Not later than 1 year after the date of enactment of this section, the Secretary, acting through the Commissioner of Food and Drugs, shall issue guidance for the conduct of clinical trials with respect to antibiotic drugs, including antimicrobials to treat acute bacterial sinusitis, acute bacterial otitis media, and acute bacterial exacerbation of chronic bronchitis. Such guidelines shall indicate the appropriate animal models of infection, in vitro techniques, and valid microbiologic surrogate markers.
`(b) Review- Not later than 5 years after the date of enactment of this section, the Secretary, acting through the Commissioner of Food and Drugs, shall review and update the guidance described under subsection (a) to reflect developments in scientific and medical information and technology.’.
SEC. 909. PROHIBITION AGAINST FOOD TO WHICH DRUGS OR BIOLOGICAL PRODUCTS HAVE BEEN ADDED.
Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by section 901(d)(2)(A), is amended by adding at the end the following:
`(kk) The introduction or delivery for introduction into interstate commerce of any food to which has been added–
`(1) a drug approved under section 505,
`(2) a biological product licensed under section 351 of the Public Health Service Act, or
`(3) a drug or biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,
unless such drug or biological product was marketed in food before any approval of the drug under section 505 of this Act, before licensure of the biological product under section 351 of the Public Health Service Act, and before any substantial clinical investigations involving the drug or biological product have been instituted, or unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, approving the addition of such drug or biological product to the food.’.
SEC. 910. ASSURING PHARMACEUTICAL SAFETY.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 505B the following:
`SEC. 505C. PHARMACEUTICAL SECURITY.
`(a) In General- The Secretary shall develop standards and identify and validate effective technologies for the purpose of securing the prescription drug distribution system against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.
`(b) Standards Development-
`(1) IN GENERAL- The Secretary shall, in consultation with the agencies specified in paragraph (3), prioritize and develop standards for the identification, validation, authentication, and tracking of prescription drugs.
`(2) PROMISING TECHNOLOGIES- The standards developed under this subsection shall address promising technologies, including–
`(A) radio frequency identification technology;
`(B) nanotechnology;
`(C) encryption technologies; and
`(D) other track-and-trace technologies.
`(3) INTERAGENCY COLLABORATION- In carrying out this subsection, the Secretary shall consult with Federal health and security agencies, including–
`(A) the Administrator of the Drug Enforcement Administration;
`(B) the Secretary of the Department of Homeland Security;
`(C) the Secretary of Commerce; and
`(D) other appropriate Federal and State agencies.
`(c) Inspection and Enforcement-
`(1) IN GENERAL- The Secretary shall expand and enhance the resources and facilities of the Office of Regulatory Affairs of the Food and Drug Administration to protect the prescription drug distribution system against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.
`(2) ACTIVITIES- The Secretary shall undertake enhanced and joint enforcement activities with other Federal agencies and State officials, and establish regional capacities for the validation of prescription drugs and the inspection of the prescription drug distribution system.
`(d) Definition- In this section, the term `prescription drug’ means a drug subject to section 503(b)(1).’.
SEC. 911. ORPHAN ANTIBIOTIC DRUGS.
(a) Public Meeting- The Commissioner of Food and Drugs shall convene a public meeting regarding which serious and life threatening infectious diseases, such as diseases due to gram-negative bacteria and other diseases due to antibiotic-resistant bacteria, potentially qualify for available grants and contracts under section 5(a) of the Orphan Drug Act (21 U.S.C. 360ee(a)) or other incentives for development.
(b) Grants and Contracts for the Development of Orphan Drugs- Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended to read as follows:
`(c) For grants and contracts under subsection (a), there is authorized to be appropriated $30,000,000 for each of fiscal years 2008 through 2012.’.
SEC. 912. AUTHORIZATION OF APPROPRIATIONS.
(a) In General- For carrying out this title and the amendments made by this title, there is authorized to be appropriated $25,000,000 for each of fiscal years 2008 through 2012.
(b) Relation to Other Funding- The authorization of appropriations under subsection (a) is in addition to any other funds available for carrying out this title and the amendments made by this title.
SEC. 913. EFFECTIVE DATE AND APPLICABILITY.
(a) Effective Date- This title takes effect 180 days after the date of the enactment of this Act.
(b) Drugs Deemed to Have Risk Evaluation and Mitigation Strategies-
(1) IN GENERAL- A drug that was approved before the effective date of this Act is, in accordance with paragraph (2), deemed to have in effect an approved risk evaluation and mitigation strategy under section 505-1 of the Federal Food, Drug, and Cosmetic Act (as added by section 901 of this title) (referred to in this section as the `Act’ ) if there are in effect on the effective date of this Act restrictions on distribution or use–
(A) required under section 314.520 or section 601.42 of title 21, Code of Federal Regulations; or
(B) otherwise agreed to by the applicant and the Secretary for such drug.
(2) ELEMENTS OF STRATEGY; ENFORCEMENT- The approved risk evaluation and mitigation strategy in effect for a drug under paragraph (1)–
(A) is deemed to consist of the elements described in paragraphs (1) and (2) of section 505-1(d) of the Act and any additional elements under subsections (d) and (e) of such section in effect for such drug on the effective date of this Act; and
(B) is subject to enforcement by the Secretary to the same extent as any other risk evaluation and mitigation strategy under section 505-1 of the Act.
(3) SUBMISSION- Not later than 180 days after the effective date of this Act, the holder of an approved application for which a risk evaluation and mitigation strategy is deemed to be in effect under paragraph (1) shall submit to the Secretary a proposed risk evaluation and mitigation strategy. Such proposed strategy is subject to section 505-1 of the Act as if included in such application at the time of submission of the application to the Secretary.
(c) Other Drugs Approved Before the Effective Date- The Secretary, on a case-by-case basis, may require the holder of an application approved before the effective date of this Act to which subsection (b) does not apply to submit a proposed risk evaluation and mitigation strategy in accordance with the timeframes provided for in subparagraphs (C) through (D) of section 505-1(g)(2) of the Act if the Secretary determines (with respect to such drug or with respect to the group of drugs to which such drug belongs) that–
(1) an element described under section 505-1(d)(1) of the Act may require modification; or
(2) a standard for adding an element described in subsection (e) or (d) of section 505-1 of the Act that is not in effect with respect to such drug or class of drugs may apply.
(d) Use of Advisory Committees; Process for Addressing Drug Class Effects- In imposing a requirement under subsection (c), the Secretary–
(1) may convene a meeting of 1 or more advisory committees of the Food and Drug Administration in accordance with paragraph (6) of section 505-1(h) of the Act; and
(2) may use the process described in paragraph (7) of such section 505-1(h) (relating to addressing drug class effects).

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