FDA ‘pink band’ delays access to birth control – again
AAs the crisis in access to reproductive health worsens in the United States, the Food and Drug Administration (FDA) is quietly working with two pharmaceutical companies to achieve a historic breakthrough in expanding access to contraception : removing the unnecessary barrier of a prescription birth control pill, and allowing people to buy it directly.
The safety and effectiveness of the pill has been well established over its 62 years on the market. This means that the FDA only has to decide two things to make it an over-the-counter product: can women understand the label on the package, and can they be trusted to follow the label to determine if these products are correct? for them?
Answering these questions seems simple. So why is the FDA moving at an excruciatingly slow pace?
Since most FDA processes are hidden from public view, it is instructive to examine the history of government bias and interference when evaluating a prior contraceptive product for use. on sale.
The last time the FDA approved an over-the-counter contraceptive product was in 2013, when it greenlighted Plan B emergency contraception — which took 10 years of lobbying to overcome political interference and social prejudice with science. I know this because I had a front row seat as a staffer working for Sen. Hillary Rodham Clinton (DN.Y.) and later for the Planned Parenthood Federation of America.
The process has endured an endless “pink stripe” – the extra hurdles that women’s products have to jump through due to societal biases. This included filing multiple FDA applications, litigation, citizen petitions, and more. Two of the FDA’s medical panels ultimately recommended that Plan B be approved. For most pharmaceutical applications, this usually leads to full FDA approval. Instead, the agency’s political leadership stepped in and canceled the experts.
For more than a year after that, public health advocates and elected officials urged the FDA to follow its experts’ recommendation. Exasperated and with no end in sight, Clinton and Sen. Patty Murray (D-Wash.) tied arms and blocked the confirmation of a new FDA commissioner for six months until they were assured that political interference would end. This led to the approval of emergency contraception, but with an arbitrary age limit of 18.
After career scientists reviewed the evidence and recommended lifting the age requirement, political figures stepped in and overturned it. Once again, public health advocates have had to organize, pressure and cajole the administration to follow the science. After nearly three more years of planning, science finally prevailed.
Despite all the wrangling and delays, the sky hasn’t fallen since Plan B has been sold on pharmacy shelves without a prescription since 2013. Instead, 24% of sexually active women of childbearing age now report having used emergency contraception, the safety of Plan B continues to be confirmed after nearly 10 years of over-the-counter use, and the testimonials of women who have benefited from it are powerful and inspiring. As states prepare to ban abortion within months, many are stocking up on plan B.
Women have certainly proven that they can understand a label and follow its instructions.
The Biden administration must learn from this experience and recognize the injustice of denying immeasurable health benefits by putting governmental barriers between women and contraception. It is critical that new FDA Commissioner Robert Califf treat these two requests for birth control pills with the urgency and seriousness that women deserve.
The pill’s six-decade safety record and current use by more than 9 million women in the United States and more than 100 million worldwide is staggering. Oral contraceptives are non-toxic, non-addictive, and pose no risk of overdose, thus meeting FDA criteria for over-the-counter access. Other over-the-counter medications carry more serious risks, including pseudoephedrine, acetaminophen, antihistamines, diet pills, aspirin, ibuprofen, and other NSAIDs. As for the health benefits, studies show that the availability of the pill without a prescription will greatly increase its use and help people control their fertility.
With increased access to the most common form of reversible contraception, the rate of unintended pregnancy in the United States would decrease by 7% to 25%. No doubt this information has led major medical groups, including the American College of Obstetricians and Gynecologists and the American Medical Association, to urge the FDA to consider making the pill available without a prescription.
The Biden administration has repeatedly and clearly stated its commitment to following science. There should be no exceptions when it comes to FDA review of over-the-counter oral contraceptives. Senator Murray – the same senator who bears the battle scars of Plan B – made her expectations clear during Califf’s confirmation hearing, saying: “[W]When it comes to women — women’s health, I expect the FDA’s decision to be based on science, as I do all FDA decisions. So, Dr. Califf, I’ll be watching…closely to make sure decisions are driven by data, not politics.
Amen, my sister. The Biden administration has an opportunity to learn from the Plan B debacle and approve the pill for over-the-counter use without delay. He just has to take it.
Dana Singiser is a partner at Keefe Singiser Partners in Washington, DC, and co-founder of the nonprofit Contraception Access Initiative.