Working Group Advocates For Over-The-Counter Access To Birth Control Pill

Main Category: Sexual Health / STDs
Also Included In: Women's Health / Gynecology;  Regulatory Affairs / Drug Approvals
Article Date: 09 Jul 2010 - 3:00 PDT

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Citing growing evidence that nonprescription access does not compromise the safety of the birth control pill, a coalition of women's health experts is working to gain FDA approval to market an oral contraceptive for nonprescription use, Newsweek reports.

The Oral Contraceptive Over-the-Counter Working Group -- a clinical and research institution administered by Ibis Reproductive Health and funded by the Hewlett Foundation -- believes prescription-only access to birth control patronizes women, restricts contraceptive freedom and does little to curb teen pregnancy rates, Newsweek reports.

The group aims to present FDA with a proposal for an OTC birth control pill this year and have the pill on the market within five years, Newsweek reports. The group is focusing on the so-called "mini-pill," which has a lower risk of adverse effects than other hormonal methods. The mini-pill typically is prescribed to women who are lactating or have a higher risk of complications, such as stroke and heart attack, because they smoke or are older than age 35. It contains the same synthetic hormone -- progestin -- that is used in the OTC emergency contraceptives Plan B and Next Choice.

Working group member Amy Allina, program and policy director for the National Women's Health Network, said, "I think we see a range of problems with access today," including "economic barriers." She added, "But there are also barriers that have more to do with the logistics of insurance, or the policy at the doctor's office."

Teens are especially likely to face problems accessing birth control because it can be difficult for them to visit a doctor's office without a parent's help, Newsweek reports. Nearly 20% of sexually active teens who do not want to become pregnant are not using contraceptives, according to the Guttmacher Institute. A 2006 study published in Contraception found that 68% of surveyed women said they wanted a birth control pill that was available without a prescription, with uninsured women exhibiting a particularly high level of interest.

Although FDA has never approved a "chronic-use" drug -- those taken daily for an indefinite period of time -- for OTC sales, FDA representative Shelly Burgess said the agency would consider applications to switch oral contraceptives from prescription to nonprescription status. "Companies interested in marketing an oral contraceptive as a nonprescription product would need to provide data to demonstrate that the proposed oral contraceptive can be used appropriately and safely by consumers without the input of a health care provider," she said.

Until recently, federally funded family planning centers followed American College of Obstetricians and Gynecologists guidelines calling for providers to perform a pelvic exam and Pap test at every family planning visit. However, new guidelines suggest that most women need less frequent screening.

"Holding birth control hostage until women have had a pelvic exam is a paternalistic attitude to women's health," Daniel Grossman, a working group member and senior researcher at Ibis, said. "The Pap smear is for cancer screening, not contraception, and we shouldn't spread misinformation by linking the two," he added.

One concern is that moving to OTC status could cause the pill's cost to jump, which is what happened when EC became available without a prescription, Newsweek reports. This could make the pill unaffordable for women whose insurance does not cover OTC drugs, according to Vanessa Cullins, vice president for medical affairs for the Planned Parenthood Federation of America.

Supporters of OTC oral contraceptive access are investigating strategies to keep costs down, such as using an off-brand production plant. Susan Harlap of the New York University School of Medicine said oral contraceptives' "low cost in many developing countries shows that pills are outrageously expensive here, and they needn't be" (Melnick, Newsweek, 7/7).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families.

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