The morning-after-pill, also known as Plan B One-Step, will not become an over-the-counter (OTC) drug for any female of reproductive age, and will remain as one that females aged at least 17 years can get over-the-counter, but sold behind the pharmacy counter. For younger girls, it will continue being a prescription-only medication.
The drug’s makers, Teva Women’s Health Inc., submitted a new drug application to the FDA in February this year to make Plan B One-Step available OTC to any girl/woman of reproductive age. Kathleen Sibelius, HHS (US Department of Health and Human Services) Secretary, says her decision does not alter the drug’s current availability for all women.
According to the studies Teva had given to FDA, the drug is effective and safe, if used properly. Sebelius said that changing its status from a prescription medication to an OTC one, requires compelling evidence that younger females who use it fully understand the label and use it appropriately. The HHS Secretary went on to say that Teva did not convince her that this is the case. The study data did not include ALL females of reproductive age (all ages) for which the morning-after-pill would be available.
In its Summary Review for Regulatory Action on Plan B One-Step, the FDA (Food and Drug Administration) recommended that Teva’s submission be approved.
Regarding this, Sebelius said:
“After careful consideration of the FDA Summary Review, I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.
American girls, on average, start menstruating when they are 12.4 years old. Approximately 10% of US females are able to get pregnant by the time they are 11.1 years old.
Sebelius added:
“It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age. If the application were approved, the product would be available, without prescription, for all girls of reproductive age.
The Secretary of the Department of Health and Human Services is responsible, acting through the FDA Commissioner, for executing the Federal Food, Drug, and Cosmetic Act. Today’s action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional. Plan B One-Step will still be available over the counter to women ages 17 and older.
Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application (SNDA) by Teva Women’s Health, Inc.”
Dr. Hamburg explained today that the FDA has been evaluating levonorgestrel-containing contraceptives for over ten years – Plan B One-Step is a levonorgestrel-containing drug. The Agency has been studying such contraceptives to determine how safe and effective they are for non-prescription usage as a way of reducing pregnancy rates after unprotected sex.
If taken within three days of unprotected sexual intercourse, Plan B One-Step, as a single dose is very effective in reducing risk of pregnancy. It works in a similar way to oral birth control pills, and uses a hormone found in these pills.
The FDA approved Plan B One-Step in July 2009 for females aged 17+ years as a non-prescription oral contraceptive, and only to be given with a doctor’s prescription for younger girls. In February 2011, Teva Woman’s Health Inc. applied to have the prescription-only status for younger girls (under 17) removed, making the drug an OTC one for all females of reproductive age.
Dr. Hamburg said:
“The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step.
Based on the information submitted to the agency, CDER 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. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.”
It is the FDA’s responsibility to approve medications that are effective and safe for their intended usage – all reviewed data are based on scientific evidence. The standard drug review process involves a thorough risk/benefit assessment.
Dr. Hamburg said:
“I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.
However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential.
Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved. Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today. Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17.
Teenage pregnancies in America are considerably higher than in other developed countries, such as Canada, Western Europe, Japan, Australia and New Zealand. In fact, America has the highest teenage pregnancy rate of the developed world.
2000-2009, Teenage birth rate per 1,000 females aged 15-19 (Source: UN)
Written by Christian Nordqvist