THE SEBELIUS DECISION: A Political Intrusion into Public Health

Vicki Darrow, MD

Plan B One-Step is a form of emergency contraception commonly referred to as the “morning-after pill.” It contains 1.5 mg of a synthetic progesterone to be taken as soon as possible after unprotected sex. It is safe, having virtually no contraindications, and it is effective: when used within three days of exposure to unprotected sex, it will decrease the risk of pregnancy by 89%.[1]

In 2009, the FDA approved Plan B One-Step for sale without a prescription to females 17 and older. Sales to females younger than 17, however, required a prescription. In December 2011, the FDA went one step farther and approved Plan B One-Step for sale without a prescription to females of all ages. But for the first time in history, the Health and Human Services Secretary (Kathleen Sebelius) overruled FDA approval of a drug. As a result, Plan B One-Step for females younger than 17 continues to require a prescription.

In a statement issued after the ruling, FDA Commissioner Dr. Margaret Hamburg wrote that the Center for Drug Evaluation and Research had “determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases.”[2] These findings came from a study by Raymond et al of more than 300 adolescent females 12-17 years old.[3] The study evaluated the participants’ understanding that Plan B One-Step was indicated for prevention of pregnancy after unprotected sex; should be taken as soon as possible after sex; does not prevent sexually transmitted diseases or HIV/AIDS; and should not be used in place of regular contraception. Despite these findings, Secretary Sebelius stated that her reason for overruling the FDA decision was because the Raymond study did not include girls who were 11 years old.

In response to Sebelius, Dr. Tina Raine-Bennett of the Women’s Health Research Institute at Kaiser Permanente Northern California said, “It is unreasonable and virtually impossible to study the use of emergency contraception in 11-year-olds, because only a small fraction of them will have had sex by that age.” Support for Dr. Raine-Bennett’s view can be found in a recent National Vital Statistics Report, which found that in births to adolescents age 19 and younger, only 1.2% occurred in those less than 15 years old.[4] In studies of teens, only 3% reported having intercourse before age 13, whereas 28% began sexual intercourse between the ages of 15-17, and 60% reported their first intercourse by age 18-19.[5]

 

In my view, female adolescents of all ages would benefit from easier access to Plan B One-Step, which provides a safe, effective form of emergency contraception. The decision by Secretary Sebelius is an example of the unwanted intrusion of politics into public health. Her decision seems to ignore the evidence-based research and recommendations of numerous scientists, public health agencies (including the CDC and the FDA), and medical associations, such as the American Medical Association, the American Congress of Obstetricians and Gynecologists, the North American Society for Pediatric and Adolescent Gynecology, and the American Academy of Pediatrics.

As a pediatric and adolescent gynecologist for Kaiser Permanente, I work with contraception issues on a daily basis, and I am a strong advocate for programs that increase the availability of emergency contraception for adolescents, such as Kaiser’s Adolescent Confidential Services program. When Plan B One-Step is prescribed by a physician for an adolescent within this program, there is no copay or fee. This waiver is especially important because the cost of Plan B One-Step at many pharmacies is around $50, which can deter adolescents from buying it. The program is available 24/7 through the Kaiser call center, which is staffed by nurses and doctors. Many of our pharmacies are also open 24/7, so the adolescent can take the medication as soon as possible after unprotected sex, when it is most effective to prevent pregnancy.

When pediatricians, gynecologists and adolescent medicine specialists at Kaiser meet with an adolescent who is presenting for contraception counseling, they order one or two packs of Plan B One-Step for the adolescent, so that she will have them on hand if she ever has an experience of unprotected sex.

 

When an adolescent female presents to any lab at Kaiser Permanente for a pregnancy test, she is directed to a counselor with the Teen Pregnancy Prevention program, who then conducts the test. If the test is positive, the adolescent is referred to an ob-gyn. If the test is negative, the counselor advises the adolescent about contraception options, prevention of STDs and the important use of condoms. If the adolescent wants hormonal contraception, the consulting physician orders oral or injectable contraception, along with Plan B One-Step. The adolescent is also counseled on the risks, benefits and side effects of contraception. In addition, the counselor performs risk assessments, conducts a urine gonorrhea and chlamydia test, takes vital signs and schedules follow-up appointments with physicians and/or nurse practitioners.

The Teen Pregnancy Prevention program has significantly decreased the unintended pregnancy rates in adolescents within Kaiser Permanente Northern California. It has also increased contraceptive use in adolescents who are sexually active and has increased the early detection and treatment of chlamydia.

The success of the various Kaiser programs in reducing teen pregnancy rates depends to a large extent on access to Plan B One-Step. Such access is probably even more critical for adolescents who are not covered by Kaiser insurance and may not have the benefit of pregnancy prevention programs.

The decision by Secretary Sebelius to overturn the FDA’s evidence-based approval of unrestricted access to Plan B One-Step is an unfortunate precedent. I am hopeful that those of us who advocate for the health and well-being of adolescent women will be able to prevail. Adolescents of all ages deserve access to this important medication, which can prevent an unintended pregnancy that would alter the course of their lives.

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Dr. Darrow is a pediatric and adolescent gynecologist at Kaiser Permanente Northern California.

 

Email: Vicki.C.Darrow@kp.org

References

1. Planned Parenthood, “How effective is the morning-after pill?” www.plannedparenthood.org (2012).

2. Hamburg M, “Statement from FDA Commissioner Margaret Hamburg, MD, on Plan B One-Step,” www.fda.gov (2011).

3. Raymond E, et al, “Comprehension of a prototype emergency contraception package label by female adolescents,”  Contraception, 79:199-205 (2009).

4. Martin JA, et al, “Births: Final Data for 2009,” National Vital Statistics Reports, 60:1 (2011).

 

5. Abma JC, et al, “Teenagers in the United States: sexual activity, contraceptive use, and childbearing,” Vital Health Stat, 23:1-47 (2010).