The Obama administration is making a sustained effort to keep the youngest girls who are sexually active from having easy access to the pregnancy-preventing drug known as “Plan B.”    Taking another step toward what may be an ultimate test in the Supreme Court, the administration will ask a federal judge in New York at a hearing Tuesday to put on hold his decision to make Plan B available over the counter — without a prescription –to women of all ages.

Such access, the federal lawyers will argue, should be open only to those who are fifteen years old or older — if they can prove their age.  That will run counter to the ruling earlier this month by Senior U.S. District Judge Edward K. Korman of Brooklyn, that the government by Wednesday must lift all restrictions on retail sales of at least one of two current versions of Plan B.

In advance of Tuesday’s hearing, however, the judge has said that he will give the administration time to ask the Second Circuit Court to delay his ruling, if he does not do so, while the government challenges it in a planned appeal.

President Obama and health officials in his government have taken up not far from where the Bush administration left off in seeking to restrict drugstore sales of Plan B — a medication that has proven to be quite effective in preventing pregnancy if taken within three days after unprotected sexual intercourse.   The main ingredient in both current versions of Plan B is a synthetic hormone, levonogesterol.  In the first version, known simply as Plan B, the drug is taken in two doses.  More recently, it has become available in a one-dose version, called Plan B One-Step.

Plan B is considered to be an “emergency” contraceptive because it is available to reduce the risk of pregnancy even after sexual activity without having taken any preventive action.

From its introduction in 1999, Plan B has been at the center of a cultural controversy over its perceived implications for teenagers beginning to engage in sexual activity.  Those who support access to it argue that teens are having sex at younger ages anyway, and need protection against pregnancy.  Critics of Plan B argue that it encourages teens to start having sex earlier, because they think they now can do so without risk.

Initially, the drug was available only with a doctor’s prescription, for any woman seeking it.  The government in 2006 began allowing women who were eighteen or older to obtain it without a prescription.  Younger women still needed a doctor’s authorization.   In 2009, in an earlier phase of the court case over Plan B that began in 2005, Judge Korman ordered the Food and Drug Administration to lower the no-prescription access age to seventeen, but eligible women still had to prove their age and could buy the product only from a pharmacy.   FDA agreed with that decision.

When Plan B One-Step — the single-pill version — gained FDA approval in 2009, the same age and other limitations still applied.

Those restrictions have been under continuous legal challenge by women’s rights advocates, who want Plan B to be made available over the counter with no age or other restrictions.  Judge Korman has been largely sympathetic to their pleas for wider access.

His 2009 decision, ordering FDA to reconsider its refusal to lift those age and sales limitations, accused the agency of acting under political pressure “emanating from the White House”– meaning, at that time, the George W. Bush White House.  The agency must consider the issue anew without yielding to such pressure, the judge declared then.

FDA did not act on the judge’s order for nearly three years, after President Obama took office.  In December 2011, the FDA decided that the one-pill version was “safe and effective and should be approved for non-prescription use for all females of child-bearing potential.”   That decision, however, was vetoed by Health and Human Services Secretary Kathleen Sebelius, who ordered the agency not to allow unrestricted marketing of Plan B One-Step to all ages. “If the application is approved,” Sebelius said at the time, “the product would be available, without a prescription or other point-of-sale restrictions, even to the youngest girls of reproductive age,” which she said might be as early as age eleven.  President Obama backed that conclusion.

That is where matters stood when Judge Korman returned to the issue in a ruling on April 5.   “This case,” he wrote, “is not about the potential misuse of Plan B by 11-year-olds.”  He added that Plan B was “among the safest drugs sold over the counter” and that, in any event, “the number of 11-year-olds using these drugs is likely to be miniscule….The invocation of the adverse effect of Plan B on 11-year-olds is an excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions.”

While the judge said that the case was controversial because it involved access to a preventive medication “for adolescents who should not be engaging in conduct that necessitates the use of such drugs,” he said the legal issue was a straightforward one about whether the government should switch a prescription drug to over-the-counter availability, and whether consumers could understand how to use such a drug safely and effectively.  “The standards,” he added, “are the same for aspirins and for contraceptives.”

Secretary Sebelius’s veto of the FDA recommendation on Plan B One-Step, the judge wrote, “forced the agency to ride roughshod over the policies and practices that it has consistently applied in considering applications for switches in drug status to over-the-counter availability.”  He said that the decision by Sebelius was based on authority that she did not have, because Congress had given the FDA, not the HHS Secretary, the authority to judge when to allow over-the-counter sales of a drug.  And, he concluded, Sebelius’s order “was politically motivated, scientifically unjustified, and contrary to agency precedent.”

Judge Korman ordered the FDA to make a version of Plan B available without a prescription and with no age or retail sale restrictions within 30 days, but he said FDA could consider adding new labeling instructions on its use, and it could choose to limit over-the-counter access solely to the one-pill version — Plan B One-Step.

Technically, Judge Korman was not acting on Sebelius’s December 7, 2011, veto of the FDA approval of Plan B One-Step, but rather on the FDA’s denial five days later of a public petition to provide unrestricted retail access to Plan B — the original, two-pill version.   But, the judge said, once Sebelius had taken the position that the drug should not be available to younger girls, that dictated what FDA could do on the retail access issue for any version, and what FDA was then compelled to do in denying access was illegal and unjustified.

However, the distinction of what was technically in front of the judge last month forms part of the legal basis of the challenge that the Obama administration will be pressing at the scheduled hearing before the judge Tuesday.

It is important to note first, however, that the FDA itself took a new position on April 30, and that decision lowered the age of access to Plan B One-Step to girls who are fifteen years old — thus making it available without a prescription for all women fifteen years old and older.  The FDA said that it was now satisfied by the drug’s manufacturer — Teva Women’s Health, Inc. — that the one-pill version could safely be sold over the counter to girls as young as fifteen.  They will have to be able to prove their age, however, and the drug will be sold only with a label requiring the cashier to check the buyer’s age.    A study by Teva, the FDA said, showed that “women age 15 and older understood that the product was not for routine use and would not protect them against sexually-transmitted diseases.”

The FDA announcement took note of the order earlier in the month by Judge Korman to lift all retail restrictions for all ages, and insisted that its move to allow access to fifteen- and sixteen-year-olds for the first time was independent of the judge’s latest decision.  It was up to the Justice Department, FDA said, to decide what it would do about the judge’s April 5 ruling.

The following day, the Justice Department notified Judge Korman that it was going to appeal his decision.  The Department argued that the judge was wrong “for at least two reasons.”   First, it said that the judge only had before him a public petition related to Plan B access, so he had no authority to order access to Plan B One-Step.  Second, it said, the judge had no authority to issue a direct marketing order, but should have sent the case back to the FDA to either reconsider its denial or to provide a fuller explanation.

Because of those asserted errors, the Department said, it stands a good chance of persuading the Second Circuit Court to overrule Judge Korman.  In the meantime, it asked the judge to put his ruling on hold while the appeal proceeds and, if he were unwilling to do even that, it asked that he grant a temporary delay so that the government can ask the Second Circuit for a postponement.  The next steps will be the subject of Tuesday’s hearing.

Posted in Plain English / Cases Made Simple, Analysis, Cases in the Pipeline, Featured

Recommended Citation: Lyle Denniston, The “Plan B” pill dispute explained, SCOTUSblog (May. 6, 2013, 2:27 PM),