More Bumps in Reproductive Healthcare Access 

At M360, we believe that all women should have control over their reproductive healthcare, including abortion and contraception. Since the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization in June of last year, the reproductive health policy landscape has changed profoundly. Women today face drastic new barriers to accessing the full range of reproductive health care, with those who are most disadvantaged and discriminated against, disproportionately harmed. 

Until recently, this uncertain and uneven landscape was a state-based problem, with different state governments working to pass laws that either limited or increased access to care. However, as we detail below, a federal judge in Texas ruled in April that the FDA’s approval of mifepristone was unlawful—a decision with the potential to drastically reduce access to critical reproductive care throughout the country. This court case—as well as state governments’ efforts in this space—continues to evolve rapidly.  


The Future of Mifepristone Use Remains Uncertain 

On April 7, a federal judge in Texas ruled in Alliance for Hippocratic Medicine et al v. U.S. Food and Drug Administration et al that the FDA’s approval of mifepristone was unlawful. Mifepristone—one of two drugs used in medication abortion—has been shown for 20 years to be safe and effective. Alongside contraception, it is part of the full range of reproductive health care that women in this country must have equitable access to ensuring that they have control over their lives and their futures.  

On April 12, the Fifth U.S. Circuit Court of Appeals partially pulled back the Texas ruling from the previous week. The court paused the ruling—meaning mifepristone would still be available—but sought to reimpose outdated rules that would restrict access. The Department of Justice (DOJ) and the manufacturer of mifepristone, Danco Laboratories, asked the Supreme Court to intervene. 

Medicines360 Signs Amicus Brief Alongside Other Pharma Companies 

If the April 7 decision stands, it will diminish the FDA’s authority over drug and device approvals, endangering innovation and ultimately women’s health across the country. Medicines360 was proud to join other leaders in the pharmaceutical industry in filing an amicus brief with the Supreme Court as well as publishing an open-letter on this case.  

On April 21, the Supreme Court granted the stay of execution, requested by the DOJ and Danco Laboratories, allowing mifepristone to retain its current FDA approval status as the case proceeds through the Fifth Circuit Court of Appeals. While the threat to unravel women’s rights and the scientific foundation of our drug and device approval process is far from over, it was reassuring to see our nation’s highest court issue a stay of execution on this case. As a result of this stay, mifepristone will remain accessible while the Fifth Circuit hears the appeal. Medicines360 released a statement on this decision. 

We will continue to follow this case closely, and continue to work however we can, to stand up for women’s rights and the scientific process. Regardless of any developments in this judicial process, Medicines360 knows that it is critical to shore up efforts to sustain and strengthen sexual and reproductive health care resources; we stand with women—always. 

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.