Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1696592500139.pdf (United States)
Congress of the United States Washington D.C. 20515 Dr. Robert M. Califf c/o U.S. Food and Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993-0002 Dear Dr. Califf: March 7, 2022 Congratulations on your appointment as Commissioner of Food and Drugs.

We look forward to working with you in your new role.

As you may know, over-the-counter oral contraceptives (OCs) will be a key issue on FDA’s agenda this year.
You are taking the helm at a time when FDA is evaluating two oral contraceptive products seeking over-the-counter status.

As Members of Congress who have long been leaders on reproductive rights and justice issues, we ask for your ongoing commitment to advance public health and follow the science and data in all decisions, including the timely review of the oral contraception applications and the evidence regarding its safety and efficacy.
This is a critical issue for reproductive health, rights, and justice.

Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system.

These barriers are disproportionately borne by people of color, immigrants, LGBTQ+ people, low-income individuals, young people, and people in rural communities – individuals who have faced and continue to face the greatest inequities.
FDA has an important role to play in removing unnecessary barriers to provide individuals greater control over their reproductive lives and health.

Birth control pills are one of the most studied medicines on the market today and they meet FDA’s standards for over-the-counter statusi.
Additionally, evidence supports the safety and benefits of over-the-counter birth control pills with no age restriction, and adolescent sexual and reproductive health experts support access for people of all ages.ii The pill is safe: the prevalence of contraindications is low for all people, and in many cases, lower for young people.

Over-the-counter birth control pills are widely supported by health care providers and the general public for all people of reproductive age.
The American College of Obstetricians and Gynecologists supports over-the-counter access to hormonal contraception without age restrictionsiii.
Medical organizations including the American Academy of Family Physicians support making birth control pills available over the counter as safe, effective, and beneficial to overall health and well-being.iv There is broad public support as well – 70% of women of reproductive age are in favor of making birth control available over the counter without a prescription.v 1 This year poses a significant opportunity to ensure that FDA prioritizes science over politics, particularly when it comes to reproductive health.
We were encouraged to hear your commitment to following the science during your December 14, 2021 hearing in the Senate HELP Committee.

We urge FDA to review applications for over-the-counter birth control pills without delay and based solely on the data and defend against political interference during the review processes.

The health and well-being of people capable of pregnancy across America is at stake.
Again, we congratulate you on your new role as Commissioner and look forward to working with you on this critical issue.
Sincerely, Barbara Lee Member of Congress Co-Chair, Pro-Choice Caucus Ayanna Pressley Member of Congress _____/s/_____ Jake Auchincloss Member of Congress _____/s/_____ Karen Bass Member of Congress _____/s/_____ Julia Brownley Member of Congress _____/s/_____ Katherine Clark Member of Congress _____/s/_____ Steve Cohen Member of Congress Diana DeGette Member of Congress Co-Chair, Pro-Choice Caucus Judy Chu Member of Congress _____/s/_____ Nanette Diaz Barragán Member of Congress _____/s/_____ Suzanne Bonamici Member of Congress _____/s/_____ Salud Carbajal Member of Congress _____/s/_____ Yvette D. Clarke Member of Congress _____/s/_____ Gerald E. Connolly Member of Congress 2 _____/s/_____ Rosa L. DeLauro Member of Congress _____/s/_____ Mark DeSaulnier Member of Congress _____/s/_____ Lizzie Fletcher Member of Congress _____/s/_____ Lois Frankel Member of Congress _____/s/_____ Kaiali‘i Kahele Member of Congress _____/s/_____ Daniel T. Kildee Member of Congress _____/s/_____ Ann Kirkpatrick Member of Congress _____/s/_____ Brenda Lawrence Member of Congress _____/s/_____ Carolyn B. Maloney Member of Congress _____/s/_____ Betty McCollum Member of Congress _____/s/_____ Grace Meng Member of Congress _____/s/_____ Marie Newman Member of Congress _____/s/_____ Chris Pappas Member of Congress _____/s/_____ Suzan DelBene Member of Congress _____/s/_____ Adriano Espaillat Member of Congress _____/s/_____ Bill Foster Member of Congress _____/s/_____ Jimmy Gomez Member of Congress _____/s/_____ Ro Khanna Member of Congress _____/s/_____ Derek Kilmer Member of Congress _____/s/_____ Rick Larsen Member of Congress _____/s/_____ Andy Levin Member of Congress _____/s/_____ Kathy Manning Member of Congress _____/s/_____ James P. McGovern Member of Congress _____/s/_____ Gwen Moore Member of Congress _____/s/_____ Eleanor Holmes Norton Member of Congress _____/s/_____ Ed Perlmutter Member of Congress 3 _____/s/_____ Chellie Pingree Member of Congress _____/s/_____ Katie Porter Member of Congress _____/s/_____ Deborah K. Ross Member of Congress _____/s/_____ Jan Schakowsky Member of Congress _____/s/_____ Kim Schrier, M.D.
Member of Congress _____/s/_____ Jackie Speier Member of Congress _____/s/_____ Norma J. Torres Member of Congress _____/s/_____ Nydia M. Velazquez Member of Congress _____/s/_____ Jennifer Wexton Member of Congress _____/s/_____ John Yarmuth Member of Congress _____/s/_____ Mark Pocan Member of Congress _____/s/_____ Jamie Raskin Member of Congress _____/s/_____ Mary Gay Scanlon Member of Congress _____/s/_____ Adam B. Schiff Member of Congress _____/s/_____ Albio Sires Member of Congress _____/s/_____ Marilyn Strickland Member of Congress _____/s/_____ David Trone Member of Congress _____/s/_____ Debbie Wasserman Schultz Member of Congress _____/s/_____ Nikema Williams Member of Congress 4 i OCs OTC Working Group.
July 2015.

OCs Moving the birth control pill over the counter in the United States.

See here.

ii Journal of Adolescent Health.

October 2016.

Over-the-Counter Access to Oral Contraceptives for Adolescents.

60 (217) 634-640.

Available here iii American College of Obstetricians and Gynecologists.

October 2019.

Over-the-Counter Access to Hormonal Contraception.

Available here.

iv American Academy of Family Physicians.

Over-the-Counter Oral Contraceptives.

Available here.
Available here.

v Kaiser Family Foundation.

April 2021.

Women's Sexual and Reproductive Health Services: Key Findings from the 2020 KFF Women's Health Survey.

Available here.

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