AAFP Disagrees With Justice Department Blockade of OTC Access to Plan B One-Step

AAFP Members Align on Both Sides of Issue

May 08, 2013 05:05 pm Matt Brown

The AAFP has weighed in on the legal battle regarding emergency contraception now playing out in the nation's courts.

In a prepared statement issued May 6, Academy Board Chair Glen Stream, M.D., M.B.I., of Spokane, Wash., disagreed with the U.S. Department of Justice's May 1 appeal of a ruling by the U.S. District Court for the Eastern District of New York to remove the age restriction on OTC access to the single-dose levonorgestrel tablets marketed as Plan B One-Step.

In that April 4 district court ruling(www.nyed.uscourts.gov), federal judge Edward Korman ordered the FDA to allow unrestricted OTC access to all levonorgestrel-based emergency contraceptives within 30 days. Such products include the two-dose levonorgestrel product previously marketed as Plan B, but now available only in generic formulations, and Plan B One-Step.

story highlights

  • The AAFP issued an official statement on May 6 opposing the U.S. Department of Justice's May 1 appeal of a U.S. District Court ruling to remove the age restriction on OTC access to the single-dose levonorgestrel tablets marketed as Plan B One-Step.
  • In the statement, AAFP Board Chair Glen Stream, M.D., said the Justice Department's move places an unnecessary barrier between females at risk for an unintended pregnancy and the safe and effective means to prevent it.
  • The AAFP called the FDA's recent approval of OTC access to Plan B One-Step for girls 15 and older "a step forward," but pointed out that the proof-of-age identification requirement is a problem.

In the AAFP statement, Stream said the Justice Department's move places an unnecessary barrier between females at risk for an unintended pregnancy and the safe and effective means to prevent it.

"Emergency contraception should be made readily available, without restriction, to all females of child-bearing age, especially when timely access is critical for optimal effectiveness," said Stream. "On Dec. 7, 2012, the (AAFP) signed a joint letter(2 page PDF) to the Department of Health and Human Services calling for the removal of age restrictions for Plan B One-Step.

"Science and research have proven the drug to be a safe and effective means to prevent unintended pregnancies in females of all ages. Furthermore, all females should have access to emergency contraception as a back-up birth control option in cases of unprotected sex, sexual assault or contraceptive failure."

Comment on FDA Announcement

In his statement, Stream also commented on the FDA's recent decision(www.fda.gov) to approve an amended request by drug maker Teva Pharmaceuticals that Plan B One-Step be granted OTC status for females ages 15 and older.

According to an FDA news release, Plan B One-Step will be labeled "not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified," and packaged with a product code prompting a cashier to request and verify the customer's age. Those who cannot provide age verification will not be able to purchase the product. In addition, a security tag will be placed on all One-Step cartons to prevent theft.

Stream said the approval is "a step forward," but he pointed out that the move leaves some issues unresolved. "It is important to realize that a 15-year-old may lack the necessary proof-of-age identification required by law," Stream said in the statement. "In the interest of patients' safety and reproductive rights, the AAFP upholds its stance that emergency contraception should be readily available to any female, regardless of age, who may experience an unintended pregnancy."

A Brief Timeline

The action now being argued was originally brought in January 2005 to challenge the FDA's denial of a so-called Citizen Petition seeking OTC access to Plan B for women of all ages. In a ruling he made at that time, Korman agreed with the case's plaintiffs that the FDA's action was not based on the evidence presented. He vacated the FDA's denial of the petition, remanded the agency to "exercise its discretion without impermissible political intrusion," and ordered it to allow women 17 and older OTC access to Plan B.

Although the agency did not act on the remanded petition for nearly three years, it did subsequently rule on a supplemental proposal.

The FDA was poised to announce that it would grant OTC access to Plan B One-Step to all women of child-bearing age when, on Dec. 7, 2011, HHS Secretary Kathleen Sebelius effectively pulled rank on FDA Commissioner Margaret Hamburg, M.D., announcing(www.hhs.gov) that, in Sebelius' view, the data supporting the OTC release of Plan B One-Step to girls below the age of 17 were not sufficient.

AAFP Members React

Family physician Judith Chamberlain, M.D., of Brunswick, Maine, said she disagreed with Sebelius then, and she disagrees with the Justice Department now because emergency contraception is a medical issue, not a social one.

"I understand that the absolute best solution for a pregnant teen -- or pregnant anybody, for that matter -- is to talk with their family doctor and get advice about their options and STD screening -- any of the things that they might need -- but the reality is that we want to prevent unwanted pregnancies, and that's what Plan B (One-Step) does," Chamberlain said.

"We know that Plan B is one of the safest drugs ever put on the market, and we allow teenagers free rein to buy Tylenol and aspirin -- by which they can overdose and die -- but you cannot overdose and die from Plan B. I think when we know it's safe and effective -- and no matter what people say, evidence proves it does not cause an abortion in an established pregnancy -- then it needs to be available to any sexually active young woman at any age."

On the other hand, family physician Beverly Nuckols, M.D., of New Braunfels, Texas, said she has issues with the Academy statement because it is inconsistent with its own Family Medicine, Scope and Philosophical Statement.

"Family physicians not only treat the patient within the context of her family, we also strive to treat the whole patient -- 'biological, behavioral (and) social,'" Nuckols said. "In this case, the 'disease' we are trying to prevent is the high-risk behavior of unprotected sex. Parental involvement is vital to the health of children and is the best prevention for high-risk behavior, including adolescent sexual activity.

"The AAFP normally and correctly advocates parental involvement and intervention to prevent other high-risk activity, such as driving without a license, the use of guns without adult supervision, smoking, or overeating, etc.," she said. "What is the rationale for treating adolescent sexual activity any differently than we would treat other risky behavior or preventable risk factor?"

Nuckols, who serves as chair of the Christian Medical & Dental Association's Family Medicine Section, said she also has concerns about OTC Plan B One-Step because there are few controlled, randomized studies that prove levonorgestrel to be medically safe and effective for adolescents at the dosage given.

"The published data on emergency contraception don't break out the numbers of adolescent girls, but the numbers appear to be low," she said. "The closest I've found are small studies for treatment of menstrual disorders and inherited bleeding disorders by chronic use of oral or intrauterine levonorgestrel, with the youngest age at 14."