ANALYSIS-Plan B denial could be challenged by New York suit

by Reuters
Friday, 16 December 2011 22:42 GMT

NEW YORK, Dec 16 (Reuters) - As reproductive rights advocates regroup after a U.S. directive denying girls under 17 over-the-counter access to the morning-after pill, their best legal recourse may lie in a dormant 6-year-old lawsuit in federal court in Brooklyn, New York.

The lawsuit, filed in 2005, charged that the U.S. Food and Drug Administration's refusal at the time to make the Teva Pharmaceutical Industries drug, known as Plan B, available over the counter to girls and women of all ages was "not supported by medical or scientific evidence."

Since then, the FDA has allowed sales of the drug without a prescription for women aged 17 and older. But in an unexpected move, Health and Human Services Secretary Kathleen Sebelius on Dec. 7 overruled an FDA recommendation and refused to lift a requirement that girls under 17 get a prescription for Plan B.

An FDA spokeswoman said no health secretary had ever overruled the agency.

Women's health advocates said the ruling went against President Barack Obama's pledge to reassert the power of science in his administration's decisions. Critics of Plan B say the pill could lead to promiscuity, sexual abuse and fewer visits to the doctor if it is readily available for purchase.

If the Brooklyn case is revived, it could be a good vehicle with which to challenge Sebelius' decision, according to legal experts and advocates for women's reproductive rights.

If the court were to find that the government relied improperly on politics instead of science, it could order that Plan B be made available immediately over the counter to girls under 17.

The case has been largely dormant since 2009. Federal Judge Edward Korman had scheduled a hearing for last Tuesday on a matter unrelated to the Sebelius directive. But in light of that directive, he invited the plaintiffs at the hearing to reopen their legal challenge.

Korman zeroed in on the question of whether politics had trumped science in the Sebelius directive.

"I think we ought to deal with whether the secretary is focusing on the adequacy of the studies," Korman said.


Under the law, an agency is allowed to consider policy and political priorities when rendering a decision. But a judge can look at the agency's stated justification and determine whether the underlying record supports that reasoning. If it does not, the judge may find it to be "arbitrary and capricious" -- the legal standard for overruling an agency decision.

In her directive, Sebelius said she did not believe there was enough scientific evidence that young girls could properly understand how to use the drug without supervision.

But that rationale may not stand up to judicial scrutiny because the HHS directive overruled a scientific recommendation by the FDA. In this case, the FDA had recommended that a one-pill version of Plan B be made available without a prescription to girls of all ages. The earlier case involved a two-pill dose of the drug, which the FDA said was more complicated to use.

The FDA "did what they thought was right," Korman said, "and the secretary overruled it. Now we're dealing with the secretary."

The judge ordered the FDA's lawyer, Assistant U.S. Attorney Scott Landau, to turn over whatever proof the FDA and HHS relied on in deciding that girls under the age of 17 could not properly use the drug.

When Landau objected, saying the information was proprietary, Korman told him to submit a sworn statement that HHS had not ignored evidence that, for instance, girls as young as 12 might properly use Plan B.

If it had ignored that evidence, Korman said, "that would be the height of arbitrariness."

An HHS spokeswoman declined comment.

On Tuesday, an attorney for the Center for Reproductive Rights, the plaintiff in the Brooklyn case, said it would ask the court to add Sebelius as a defendant to its suit so it could challenge her decision directly.

Although Korman could order the FDA to lift the drug's age restrictions, federal courts are typically hesitant to step in and make scientific decisions, said Lars Noah, professor of law at the University of Florida.

"This is a pretty unusual instance of the nitty-gritty and sometimes unsavory details of an agency decision coming out into the daylight," Noah said. "But a reviewing court is still going to say to themselves -- 'We're just federal judges. Unless there are clear or procedural or substantive missteps, it's not our business.'"

(Reporting by Jessica Dye; Editing by Peter Cooney)

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