STATE OF NEW YORK ________________________________________________________________________ 1175 2025-2026 Regular Sessions IN ASSEMBLY January 9, 2025 ___________ Introduced by M. of A. PEOPLES-STOKES, SANTABARBARA -- read once and referred to the Committee on Health AN ACT to amend the public health law, in relation to creating the lupus research enhancement program; and to amend the state finance law, in relation to creating the lupus research enhancement fund The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. Article 2 of the public health law is amended by adding a 2 new title 4-A to read as follows: 3 TITLE IV-A 4 LUPUS RESEARCH ENHANCEMENT ACT 5 Section 256. Short title. 6 256-a. Legislative intent. 7 256-b. Definition. 8 256-c. Lupus research enhancement program. 9 256-d. Lupus research advisory council. 10 256-e. Lupus research enhancement fund. 11 § 256. Short title. This title shall be known and may be cited as the 12 "lupus research enhancement act". 13 § 256-a. Legislative intent. 1. The legislature hereby finds the 14 following: 15 (a) Lupus is a serious, complex, debilitating autoimmune disease that 16 can cause inflammation and tissue damage to virtually any organ system 17 in the body, including the skin, joints, other connective tissue, blood 18 and blood vessels, heart, lungs, kidney, and brain. 19 (b) The Lupus Foundation of America, Inc. estimates that approximately 20 1.5 to two million Americans live with some form of lupus; lupus affects 21 women nine times more often than men and eighty percent of newly diag- 22 nosed cases of lupus develop among women of childbearing age. 23 (c) Lupus disproportionately affects women of color - it is two to 24 three times more common among African-Americans, Hispanics, Asians and EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD02986-01-5
A. 1175 2 1 Native Americans and is generally more prevalent in minority populations 2 - a health disparity that remains unexplained. According to the Centers 3 for Disease Control and Prevention the rate of lupus mortality has 4 increased since the late nineteen seventies and is higher among older 5 African-American women. 6 (d) No new drugs have been approved by the U.S. Food and Drug Adminis- 7 tration specifically for lupus in nearly forty years, and while current 8 treatments for the disease can be effective, they can lead to damaging 9 side effects. 10 (e) The pain and fatigue associated with lupus can threaten people's 11 ability to live independently, make it difficult to maintain employment 12 and lead normal lives, and one in five people with lupus is disabled by 13 the disease, and consequently receives support from government programs, 14 including medicare, medicaid, social security disability, and social 15 security supplemental income. 16 (f) The estimated average annual cost of medical treatment for an 17 individual with lupus can range between ten thousand dollars and thirty 18 thousand dollars; for people who have the most serious form of lupus, 19 medical costs can greatly exceed this amount, causing a significant 20 economic, emotional and social burden to the entire family and society. 21 (g) More than half of the people with lupus suffer four or more years 22 and visit three or more physicians before obtaining a diagnosis of 23 lupus; early diagnosis of and commencement of treatment for lupus can 24 prevent or reduce serious organ damage, disability, and death. 25 (h) Despite the magnitude of lupus and its impact on individuals and 26 families, health professional and public understanding of lupus remains 27 low; only one of five Americans can provide even basic information about 28 lupus, and awareness of lupus is lowest among adults ages eighteen to 29 thirty-four - the age group most likely to develop symptoms of lupus. 30 (i) Lupus is a significant national health issue that deserves a 31 comprehensive and coordinated response by state and federal governments 32 with involvement of the health care provider, patient, and public health 33 communities. 34 2. The purposes of this title are: 35 (a) To promote basic and clinical research programs designed to reduce 36 or prevent suffering from lupus, by providing additional funding to 37 state academic medical institutions within the state currently conduct- 38 ing or having an interest in conducting basic and clinical, social, 39 translational, technological, epidemiological, and behavioral research 40 on lupus. Such activities may include: 41 (i) investigating the pathogenesis and physiology of lupus; 42 (ii) identifying and validating lupus biomarkers; 43 (iii) enhancing the statewide infrastructure to conduct clinical 44 trials of potential new lupus therapies; 45 (iv) developing or improving diagnostic tests for early detection of 46 lupus; and 47 (v) developing novel therapies to treat lupus. 48 (b) To establish a multidisciplinary lupus research advisory council 49 to monitor progress and make granting recommendations to the department. 50 § 256-b. Definition. As used in this title, "program" shall mean the 51 lupus research enhancement program created pursuant to section two 52 hundred fifty-six-c of this title. 53 § 256-c. Lupus research enhancement program. 1. The commissioner shall 54 establish within the department a lupus research enhancement program 55 through which the department shall make grants to state academic medical 56 institutions within the state currently conducting or having an interest
A. 1175 3 1 in conducting basic and clinical, social, translational, technological, 2 epidemiological, and behavioral research on lupus. 3 2. All research funds shall be awarded on the basis of the research 4 priorities established for the program and the scientific merit of the 5 proposed research, as determined by an open, competitive peer review 6 process that ensures objectivity, consistency, and high quality. All 7 investigators, regardless of affiliation, shall have equal access and 8 opportunity to compete for program funds. 9 3. The peer review process for the selection of research grants 10 awarded under this program shall be modeled generally on that used by 11 the national institutes of health in its grant making process. 12 4. An awardee shall be awarded grants for the full cost, both direct 13 and indirect, of conducting the sponsored research consistent with those 14 federal guidelines governing all federal research grants and contracts. 15 All intellectual property assets developed under this program shall be 16 treated in accordance with state and federal law. 17 5. In establishing its research priorities, the state shall consult 18 with the lupus research advisory council and consider a broad range of 19 cross-disciplinary lupus research, including, but not limited to, 20 research into the cause, cure, and diagnosis of lupus; translational and 21 technological research, including research to develop improved diagnos- 22 tic tests; research regarding the cultural, economic, and legal barriers 23 to accessing the health care system for early detection and treatment of 24 lupus; and research examining the health disparities seen in the inci- 25 dence and prevalence of lupus. 26 § 256-d. Lupus research advisory council. 1. Operations. (a) The coun- 27 cil shall be comprised of fifteen members representing a broad range of 28 expertise and experience. 29 (b) Individuals and organizations may submit nominations to the 30 commissioner through the council. 31 (c) Each appointed council member should have familiarity with lupus 32 and issues that surround lupus and be one of the following: health and 33 medical professional with expertise in lupus; an individual with lupus; 34 a representative from a local or county health department; or a recog- 35 nized expert in the provision of health services to women, lupus 36 research or health disparities. 37 (d) The council shall be comprised as follows: 38 (i) at least three individuals with lupus; 39 (ii) no more than two representatives from the department; 40 (iii) at least five individuals from lupus nonprofit health organiza- 41 tions; and 42 (iv) at least five scientists or clinicians with experience in lupus 43 and who participate in various fields of scientific endeavor, including, 44 but not limited to, the fields of biomedical research, social, transla- 45 tional, behavioral and epidemiological research, and public health. 46 (e) All members of the council shall be appointed by the commissioner 47 and the commissioner shall choose from among the fifteen council members 48 one member to serve as chair. 49 (f) All members of the council shall serve terms of two years each. 50 Members can be named to serve a total of two terms and terms can be 51 consecutive. 52 (g) Members shall serve without compensation, but shall be entitled to 53 actual, necessary expenses incurred in the performance of their business 54 as members of the council.
A. 1175 4 1 (h) A majority of the members of the council shall constitute a 2 quorum. A majority vote of a quorum shall be required for any official 3 action of the council. 4 (i) The council shall meet at the call of the chair, but not less than 5 four times per year. 6 2. Functions. The lupus research advisory council shall: 7 (a) review submitted grant applications and make recommendations to 8 the commissioner, and the commissioner shall, at their discretion, grant 9 approval of applications for grants from those applications recommended 10 by the council (if a council member submits an application for a grant 11 from the lupus research and education fund, such council member will be 12 prohibited from reviewing and making a recommendation on the applica- 13 tion); 14 (b) consult with the national institutes of health, centers for 15 disease control and prevention, the agency for healthcare research and 16 quality, the national academy of sciences (institute of medicine), lupus 17 advocacy groups, and other organizations or entities which may be 18 involved in lupus research to solicit both information regarding lupus 19 research projects that are currently being conducted and recommendations 20 for future research projects; and 21 (c) shall transmit annually on or before December thirty-first, a 22 report to the legislature on grants made, grants in progress, program 23 accomplishments, and future program directions. Each report shall 24 include, but not be limited to, the following information: 25 (i) the number and dollar amounts of research grants, including the 26 amount allocated to indirect costs; 27 (ii) the subject of research grants; 28 (iii) the relationship between federal and state funding for lupus 29 research; 30 (iv) the relationship between each project and the overall strategy of 31 the research program; 32 (v) a summary of research findings including discussion of promising 33 new areas; 34 (vi) the institutions and campuses receiving grant awards; and 35 (vii) the first annual report shall include an evaluation and recom- 36 mendations concerning the desirability and feasibility of requiring 37 for-profit grantees to compensate the state in the event that a grant 38 results in the development of a profit-making product. This evaluation 39 shall include, but not be limited to, the costs and benefits of requir- 40 ing a for-profit grantee to repay the grant, to provide the product at 41 cost to state programs serving low-income lupus patients, and to pay the 42 state a percentage of the royalties derived from the product. 43 3. Contributions. The secretary of the lupus research advisory council 44 may accept grants, services, and property from the federal government, 45 foundations, organizations, medical schools, and other entities as may 46 be available for the purposes of fulfilling the obligations of this 47 program. Any such funds shall supplement and not supplant appropriations 48 provided for the implementation of this article. 49 4. Waivers. The secretary of the lupus research advisory council shall 50 seek any federal waiver or waivers that may be necessary to maximize 51 funds from the federal government to implement this program. 52 § 256-e. Lupus research enhancement fund. All moneys received pursuant 53 to section two hundred fifty-six-c of this title shall be credited to 54 the fund, as established by section ninety-five-l of the state finance 55 law. The commissioner shall use the fund to administer the lupus
A. 1175 5 1 research enhancement program and to make grants to awardees pursuant to 2 section two hundred fifty-six-c of this title. 3 § 2. The state finance law is amended by adding a new section 95-l to 4 read as follows: 5 § 95-l. Lupus research enhancement fund. 1. There is hereby estab- 6 lished in the joint custody of the commissioner of taxation and finance 7 and the comptroller, a special fund to be known as the "lupus research 8 enhancement fund". 9 2. Such fund shall consist of all monies appropriated for the purpose 10 of such fund and any grant, gift or bequest made to the lupus research 11 enhancement program as established by title four-A of article two of the 12 public health law. 13 3. Moneys of the fund shall be available for grants through the lupus 14 research enhancement program advisory council and for the expenses of 15 the lupus research enhancement program advisory council, and shall be 16 expended only for the purposes spelled out in sections two hundred 17 fifty-six-c and two hundred fifty-six-d of the public health law. 18 4. Moneys in the lupus research enhancement fund shall be kept sepa- 19 rate and shall not be commingled with any other moneys in the custody of 20 the commissioner of taxation and finance and the comptroller. 21 5. The moneys of the fund shall be paid out on the audit and warrant 22 of the comptroller on vouchers certified or approved by the commissioner 23 of health, or by an officer or employee of the department of health 24 designated by such commissioner. 25 § 3. This act shall take effect immediately.