Posts Tagged ‘emergency contraception’

April 12, 2013

The Long Political History of Increasing Access to Emergency Contraception

Last week, a judge ordered the FDA to make emergency contraception pills available over the counter, with no age restrictions, capping a long and frustrating legal battle to increase access.

Versions of levonorgestrel-based emergency contraceptive pills (such as Plan B and Next Choice) are expected to be made available without restriction within 30 days, but it’s not clear whether there will be some administrative interference. The FDA might decide on new labeling or to limit the forms of emergency contraception made available. There is also the possibility that the decision will be appealed.

OTC access for all ages is essential because most emergency contraception pills are most effective when used as soon as possible, and time, distance, money, and privacy can be serious barriers, especially for teenagers, to obtaining and filling a prescription in time to prevent pregnancy.

The push to make emergency contraception pills (also known as morning-after pills) available to all ages without a prescription suffered a major setback in 2011, when HHS Sec. Kathleen Sebelius blocked the FDA’s decision to remove the age barrier. Since 2009, emergency contraception has been available without a prescription for anyone age 17 and older.

Sebelius’s objections focused on the idea that young girls would use EC in unsafe ways. Susan Wood, A former director of the FDA’s Office of Women’s Health who in 2005 resigned over political delays around emergency contraception, rejected Sebelius’s claim that more data was needed on safety and label comprehension, noting that “this type of age restriction, and worries about the use of medicines by teenagers, have not been applied to other products.”

U.S. District Judge Edward R. Korman, in reversing the FDA’s decision to deny a citizen petition for all-ages access, seems to agree that the “What about 11-year-olds?” objection is merely a smokescreen. From the memorandum:

This case is not about the potential misuse of Plan B by 11-year-olds. These emergency contraceptives would be among the safest drugs sold over-the-counter, the number of 11-year-olds using these drugs is likely to be miniscule, the FDA permits drugs that it has found to be unsafe for the pediatric population to be sold over-the-counter subject only to labeling restrictions, and its point-of-sale restriction on this safe drug is likewise inconsistent with its policy and the Food, Drug, and Cosmetic Act as it has been construed.

Instead, the invocation of the adverse effect of Plan B on 11-year-olds is an excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions.

Korman characterized Sebelius’s actions as “obviously political” and “arbitrary, capricious, and unreasonable,” and wrote:

Nevertheless, even with eyes shut to the motivation for the Secretary’s decision, the reasons she provided are so unpersuasive as to call into question her good faith. While the Secretary has strung together three factual statements in her memorandum to Commissioner Hamburg, she has failed to offer a coherent justification for denying the over-the-counter sale of levonorgestrel-based emergency contraceptives to the overwhelming majority of women of all ages who may have need for those drugs and who are capable of understanding their correct use.

While we’re celebrating the judge’s ruling, we should also keep in mind the fact that President Obama is still praising Sebelius’s unprecedented, access-denying interference and overriding of the FDA’s scientific review process.

More coverage:

Background information from Our Bodies Ourselves:


December 6, 2012

Pros and Cons of Making the Birth Control Pill Available Without a Prescription

condom and the pill

Though it won’t be as accessible as condoms, health experts are proposing to make the birth control pill available without a prescription. Photo / Jenny Lee Silver

This month, the American College of Obstetricians and Gynecologists released a statement calling for oral contraceptives to be sold over-the-counter, no longer requiring a doctor’s prescription.

ACOG considered a host of issues, including the safety of birth control pills; whether pharmacists could screen for who shouldn’t get them, or if women could self-screen; adherence to taking the pill; whether women would skip other preventive care if they didn’t visit a health care provider for a prescription; and cost.

Notably, ACOG addresses frequent objections to OTC oral contraceptives by concluding that “several studies have shown that women can self-screen for contraindications,” and “cervical cancer screening or sexually transmitted infection (STI) screening is not required for initiating OC use and should not be used as barriers to access.”

As Kevin Drum points out at Mother Jones, most countries outside of North America and Europe do not require a prescription for these drugs.

ACOG notes, though, that making the pill non-prescription might increase the cost for women who have health insurance — especially since under health care reform, contraception can be purchased without a co-pay. Over-the-counter costs might end up being anything from the $4 deals many pharmacies offer to more than $100. Dr. Kent Sepkowitz also explores this concern at The Daily Beast:

Yes, your life is easier because you will be able to get the pill right this second, without calling my office. No, you don’t need to fill out forms and show insurance cards and wrangle over copay. But guess who is paying for the whole shabang? You. Yes, you.

Another concern is that if the pill were dispensed by pharmacists, we might see the more of same kinds of refusals as have happened with emergency contraception.

However, many patients may experience increased access with an OTC model. The National Latina Institute for Reproductive Health issued this response:

The recommendation that birth control be available over-the-counter supports what we know about Latinas and contraception: over-the-counter access will greatly reduce the systemic barriers, like poverty, immigration status and language, that currently prevent Latinas from regularly accessing birth control and results in higher rates of unintended pregnancy.

Pre-Prescribing Emergency Contraception to Teens
Another professional medical organization, the American Academy of Pediatrics, issued a statement recognizing high teen birth rates in the United States and barriers to access to emergency contraception for adolescents 17  and younger. The AAP strongly admonishes pediatricians who refuse to discuss or provide contraception to teens based on their own beliefs, stating:

Pediatricians have a duty to inform their patients about relevant, legally available treatment options to which they object and have a moral obligation to refer patients to other physicians who will provide and educate about those services. Failure to inform/educate about availability and access to emergency-contraception services violates this duty to their adolescent and young adult patients.

The AAP recommends that physicians provide prescriptions to emergency contraception like Plan B in advance, so teens have it ready if and when the need arises. They also urge physicians to provide accurate information to teens on this topic, and, “At the policy level, pediatricians should advocate for increased nonprescription access to emergency contraception for teenagers regardless of age and for insurance coverage of emergency contraception to reduce cost barriers.”

Nice job, AAP!

HHS Urged to Remove Restrictions on Emergency Contraception
Finally, a petition is circulating urging the U.S. Department of Health and Human Services to remove restrictions on emergency contraception and make it available to women of all ages without a prescription. To learn more, see RH Reality Check’s audio news conference and related links and commentary from Kristin Moore. Our previous posts provide background on why EC is not *already* available OTC to all women: