Medicines360 Applauds HELP Committee for Including Critical Amendments on Nonprofit Pharma in Legislation Headed to Senate Floor  

Committee member Senator Rosen has been a leading voice supporting the nonprofit pharmaceutical model

San Francisco, CA –  Earlier this week, the United States Senate Health, Education, Labor, and Pensions (HELP) Committee advanced the Food and Drug Administration Safety and Landmark Advancements (FDASLA Act/ S. 4348) Act to the full Senate floor with broad bipartisan support, adding two critical amendments spearheaded by Committee Members Jacky Rosen (D-NV) and Mitt Romney (R-UT). One amendment would direct the Government Accountability Office (GAO) to conduct a report on the impact that nonprofit drug companies would have on lowering drug costs, addressing drug shortages, and accelerating the development of new drugs. The report would also look at existing barriers to the success of nonprofit pharmaceutical organizations, and what Congress can do to support them. The second amendment would instruct the U.S. Food and Drug Administration (FDA) to hold a public meeting on the value of nonprofit drug organizations, how those nonprofits can help address patient access issues, and whether future user fee processes should be altered to better support their work.

Statement from Autumn Ehnow, Executive Vice President, Policy and Strategic Market Access at Medicines360 

We are grateful to Chair Murray, Sen. Rosen, and Sen. Romney for their leadership in including these critical amendments in the FDASLA Act. Nonprofit pharmaceutical organizations like ours serve as a bridge to better health by serving the public, building health equity, and filling gaps in access. Without the need to maximize profits for shareholders, nonprofits can focus on how best to stabilize supply, lower costs and improve access for people across the country. Expanding access to critical medicines and devices is at the heart of our work, and we are confident this report and public meeting will display the incredible value of that mission.” 

In May, Sens. Rosen and Romney introduced S.4341, standalone legislation that would call for the same GAO report included among this week’s amendments. With the addition of these amendments, the FDASLA Act becomes the fourth piece of legislation in the 117th Congress that would support the work of nonprofit pharmaceutical organizations. Sen. Rosen has been a leading champion for the nonprofit pharmaceutical model and the driver of this congressional momentum. In 2021, Sen. Rosen introduced the Expanding Access to Affordable Prescription Drugs and Medical Devices Act (S.2257), which would improve the ability of nonprofit pharmaceutical organizations to sustainably provide affordable medicines to U.S. patients in a number of ways. It would clarify their ability to qualify for federal tax-exempt status, provide financial support to nonprofits working to develop and manufacture needed drugs, waive burdensome Food & Drug Administration (FDA) user fees, and provide new opportunities for priority FDA review for certain drugs made by nonprofits.

About Medicines360 

Medicines360, located in San Francisco, California, is a global nonprofit women’s health pharmaceutical organization with a mission to remove cost as a barrier to health by developing and providing affordable women’s health products. Medicines360 is committed to working with healthcare providers, advocacy groups and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit www.medicines360.org 

 
Press Contact: Stacey Manley 
Vice President, Communications & Marketing 
smanley@Medicines360.org    415.951.8700  

About Medicines360

Located in San Francisco, California, Medicines360 is a global nonprofit pharmaceutical organization with a mission to accelerate the timeline from health innovation to access for all women. Medicines360 is committed to working with healthcare providers, advocacy groups, and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit www.medicines360.org.

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AVIBELA can be made available in the following 88 countries

  1. Algeria
  2. Angola
  3. Bangladesh
  4. Belize
  5. Benin
  6. Bhutan
  7. Botswana
  8. Burkina Faso
  9. Burundi
  10. Cambodia
  11. Cameroon
  12. Cape Verde
  13. Central African Republic
  14. Chad
  15. Comoros
  16. Costa Rica
  17. Cuba
  18. Democratic Republic of the Congo
  19. Djibouti
  20. Dominica
  21. Dominican Republic
  22. Egypt
  23. El Salvador
  24. Equatorial Guinea
  25. Eritrea
  26. Ethiopia
  27. Gabon
  28. Ghana
  29. Grenada
  30. Guatemala
  31. Guinea
  32. Guinea-Bissau
  33. Haiti
  34. Honduras
  35. India
  36. Indonesia
  37. Ivory Coast
  38. Jamaica
  39. Kenya
  40. Lao PDR
  41. Lesotho
  42. Liberia
  43. Libya
  44. Madagascar
  45. Malawi
  46. Malaysia
  47. Maldives
  48. Mali
  49. Mauritania
  50. Mauritius
  51. Mayotte
  52. Morocco
  53. Mozambique
  54. Myanmar
  55. Namibia
  56. Nepal
  57. Nicaragua
  58. Niger
  59. Nigeria
  60. Pakistan
  61. Panama
  62. Papua New Guinea
  63. Philippines
  64. Republic of the Congo
  65. Rwanda
  66. Sao Tome and Principe
  67. Senegal
  68. Seychelles
  69. Sierra Leone
  70. Somalia
  71. South Africa
  72. South Sudan
  73. Sri Lanka
  74. Kitts and Nevis
  75. Lucia
  76. Vincent & the Grenadines
  77. Sudan
  78. Swaziland
  79. Tanzania
  80. Thailand
  81. The Gambia
  82. Timor-Leste
  83. Togo
  84. Tunisia
  85. Uganda
  86. Vietnam
  87. Zambia
  88. Sri Lanka

Tina Raine-Bennett, MD, MPH, FACOG

Chief Executive Officer

Tina Raine-Bennett, MD, MPH, is CEO of Medicines360. Previously, she served as a senior research scientist at the Kaiser Permanente Northern California Division of Research and the research director of the Women’s Health Research Institute. She is a Board-Certified Obstetrician Gynecologist who received her medical training at the University of California, San Diego, and post-graduate residency training and MPH at the University of Washington in Seattle, where she also completed a Robert Wood Johnson Clinical Scholars Fellowship. She was also senior staff physician at Kaiser Permanente and has a special interest in family planning and adolescent reproductive health.

As the director of the Women’s Health Research Institute, Dr. Raine-Bennett focused on expanding research on women’s health within the Division and translating women’s health research into clinical practice and policy within the Ob/Gyn departments in Northern California. She also promoted the involvement of clinicians in research designed to improve the health outcomes and healthcare experiences of women at Kaiser Permanente and women in general.

Prior to Kaiser Permanente, Dr. Raine-Bennett was a professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at University of California, San Francisco (UCSF). She was based at San Francisco General Hospital where she was also the medical director of the New Generation Health Center, a UCSF affiliate site that provides community-based reproductive health services. Dr. Raine-Bennett’s research has focused on contraceptive methods and on elucidating factors that influence contraceptive choice and continuation, and she was principal investigator on NIH grants to assess hormonal contraceptive use predictors and develop interventions to improve contraceptive access.

Her past and current research on emergency contraception has focused on the safety of making emergency contraception more accessible and she conducted a pivotal clinical trial to make emergency contraception available to teens without a prescription. She served on the editorial board of Obstetrics and Gynecology and has over 100 peer-reviewed publications. She was the Treasurer of the Board of Directors for the Society of Family Planning and Society of Family Planning Research Fund. She has also served as an examiner for the American Board of Obstetrics and Gynecology, and on national committees for the American College of Obstetrics and Gynecology and the National Medical Board of Planned Parenthood Federation of America.