Appeals court to decide if Plan B can be sold to all ages

Physician opinions vary about whether so-called morning-after birth control should be available over the counter without doctor involvement.

By — Posted May 27, 2013

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The Obama administration is asking the 2nd U.S. Circuit Court of Appeals to block a federal court ruling allowing women and girls of all ages to purchase a common emergency contraceptive without a prescription.

The U.S. Dept. of Justice on May 13 asked the appellate court to examine the issue after a federal judge refused to delay his April decision ordering age restrictions removed on Plan B and its generic equivalents. If the appeals court denies the injunction, the Food and Drug Administration is required to comply immediately with the federal court order.

The Justice Dept.’s attempt to stop the federal court decision is fueled by politics and not a desire to protect the safety and best interest of all women, said Andrea Costello, an attorney with the Partnership for Civil Justice Fund. The civil rights law firm represents the plaintiffs in the case, including activists with National Women’s Liberation, a feminist group.

“What we’re seeing right now is really an entrenchment,” Costello said. “We’re really seeing the political position by the administration about access to birth control. If the current administration really wants to promote women’s reproductive rights and women’s reproductive health in the way they say they do, and to prevent teenage pregnancy, fighting this case is really not the way to do that.”

The Justice Dept. had not returned messages seeking comment at this article’s deadline. In its emergency motion to the appeals court, the Justice Dept. said the federal judge’s sweeping order fundamentally misinterprets the process by which the FDA can change the status of a prescription drug to nonprescription.

“Because the district court plainly overstepped its authority, there is a substantial likelihood that the government will prevail in this appeal,” the Justice Dept. said. “The balance of harms and the public interest also strongly support a stay. Absent a stay, the government will be required to make drugs available without prescription or age restriction, outside of the statutorily required process for doing so.”

Disagreements on age limits

On April 4, U.S. District Court Judge for the Eastern District of New York Edward Korman overturned a 2011 policy by the Dept. of Health and Human Services that required girls 16 and younger to have a prescription before they could access the so-called morning-after pill. HHS previously had rejected a recommendation by the FDA to expand availability of such birth control.

In his ruling, Korman said the standard for determining whether contraceptives should be available over the counter to all rests solely on the ability of the consumer to understand how to use the particular drug “safely and effectively.” Korman called the Justice Dept.’s reasoning as to why he should delay his order “frivolous.” Remanding his ruling to the FDA for further decision-making procedures would be an abuse of discretion, he said.

After Korman’s initial decision, the FDA announced that it will make a brand of emergency contraception, Plan B One-Step, available over the counter to girls and women 15 and older.

But Costello said the FDA’s new requirement has underlying rules that will only confuse young women. For instance, girls can access Plan B only from a store that has an on-site pharmacy. In addition, 15-year-old girls would be required to show identification, which many do not have, she said.

The FDA change has “created an even more confusing process and procedure for women and girls to know how to access emergency contraceptive,” she said.

Conflicting views on drug availability

Making Plan B available to all girls without a prescription keeps young women away from necessary doctor visits, evaluation and testing, said David Stevens, MD, CEO of the Christian Medical & Dental Assns.

“We have an epidemic of sexually transmitted diseases, and now we’re going to have one less reason that girls come to see a physician,” he said.

If Korman’s decision stands, teenage sexual activity will rise, because children will know they can obtain emergency contraceptives easily, Dr. Stevens said.

“We can argue about whether [Plan B] is safe or not and other issues, but I get concerned when a judge can change health care policy and trump HHS and other agencies in this country,” he said. “Judges don’t know anything about public health.”

Other physicians took a different view. Science has long shown that emergency contraceptives such as Plan B are a safe and effective means to prevent unwanted pregnancies, said Judith Chamberlain, MD, a family physician in Maine. Doctors want young girls to visit them for counseling and testing, but that is not the reality, she said.

“I can probably count on one hand the number of young girls who have called and said, ‘I need help. I need that morning-after pill,’ ” she said. “It’s very uncommon. If we’re going to prevent unwanted pregnancies, we have to make it easy for them to get the medication to do that.”

American Medical Association policy “urges that established emergency contraception regimens be approved for over-the-counter access to women of reproductive age, as recommended by the relevant medical specialty societies and the [FDA’s] own expert panel.”

In 2012, the AMA, along with other medical associations such as the American Academy of Family Physicians and the American Academy of Pediatrics, sent a letter to HHS Secretary Kathleen Sebelius asking that the government re-examine restrictions on Plan B.

“As voluminous research shows, Plan B safely helps teen and adult women prevent unintended pregnancies,” the letter said. “All women should have emergency contraception as a backup birth control option in cases of unprotected sex, sexual assault or contraceptive failure.”

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External links

Annie Tummino, et al. v. Margaret Hamburg, Commissioner of Food and Drugs, et al., U.S. District Court for the Eastern District of New York, May 10 (link)

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