Plan B One-Step and equivalent emergency contraception products must be approved for universal OTC access by May 4, under a federal judge’s ruling against FDA and the Department of Health and Human Services.

Twelve years after being filed and more than a year after being denied, the Center for Reproductive Rights’ citizen petition seeking OTC status for all levonorgestrel emergency contraceptives was revived by Judge Edward Korman of the U.S. District Court for the Eastern District of New York. His April 4 memorandum and order reverse FDA’s denial of the petition and direct the agency to approve it within 30 days.

If the Obama administration intends to buck the ruling, it is in the Department of Justice’s hands to pursue an appeal in the Second Circuit Court of Appeals. A department spokeswoman said in an email that DoJ “is reviewing the appellate options and expects to act promptly.”

Meanwhile, women’s health advocates celebrated what they see as a hard-fought victory for science over politics.

Judge Edward Korman

Photo courtesy of U.S. District Court for the Eastern District of New York

“This landmark court decision has struck a huge blow to the deep-seated discrimination that has for too long denied women access to a full range of safe and effective birth control methods,” said Nancy Northup, CRR’s president and CEO, in a statement.

Should Korman’s order stand, Teva Pharmaceutical Industries Ltd.’s One-Step (levonorgestrel 1.5 mg), the Next Choice branded generic from Allergan PLC, and other private-label equivalents would move to retail shelves from behind the pharmacy counter, where they are available currently without a prescription only to consumers aged 17 and older.

Judge Not Persuaded By Sebelius

Korman’s decision is not surprising given indications he gave during an April 2012 hearing, and in light of his 2009 order that required FDA to lower the nonprescription age restriction on the original two-dose formulation of Plan B from 18 years Also see "Judge Likely To Order Lower Age Restriction For Emergency Contraceptives" - Pink Sheet, 7 May, 2012..

The judge has harsh words in his memorandum for HHS Secretary Kathleen Sebelius, who in December 2011 rejected the regulatory decision by FDA reviewers to approve One-Step for full OTC sale Also see "Teva Plan B OTC Application Fails Political Test After Clearing FDA Hurdle" - Pink Sheet, 12 December, 2011..

“The motivation for the secretary’s action was obviously political,” given the culturally sensitive issue of contraception and the timing of her decision, going into an election year, Korman writes.

“Nevertheless, even with eyes shut to the motivation for the secretary’s decision, the reasons she provided are so unpersuasive as to call into question her good faith,” the judge adds.

Sebelius couched her decision to overrule FDA in the drug application’s lack of label comprehension and actual use data for 11-year females, 10% of whom have reached reproductive age and thus are in Plan B One-Step’s patient population.

But Korman points out that FDA waived the requirement for a minimum number of enrollees between ages 11 and 13 in Teva’s studies. Experts have noted that recruiting study participants in that age group, in numbers sufficient to quell Sebelius’ concerns, would have been nearly impossible.

The judge also was unimpressed by Sebelius’ concern that One-Step would be available OTC to the youngest girls of reproductive age, given the lack of safety concerns associated with levonorgestrel.

As counterpoints to Sebelius’ position, Korman cites the nonprescription availability of proton pump inhibitors and the weight-loss drug alli (orlistat) – which are labeled as not approved for pediatric use – as well as dextromethorphan-containing cough syrups, which often are abused by teenagers. “FDA’s willingness to rely on labeling to make these drugs available for sale over-the-counter without any age or point-of-sale restrictions, even though they are unsafe for unsupervised use by young adolescents, stands in stark contrast to its refusal to make equally available concededly safe and time-sensitive levonorgestrel-based emergency contraceptives,” Korman writes.

Though FDA has a history of allowing drug sponsors to extrapolate data from older patients to younger patients, Sebelius apparently ignored this, the judge notes. FDA also deviated from this practice in denying CRR’s citizen petition in December 2011 – a denial Korman calls “unsound.”

Teva Exclusivity Loses Out

As the litigation unfolded in spring 2012 following Sebelius’ intervention, Teva came out against any judicial action that would cause it to lose the three years of OTC market exclusivity it believed it earned on the basis of label comprehension and actual use studies conducted to support the One-Step Rx-to-OTC switch Also see "FDA Contests Court Intervention On Plan B As Teva Argues For Exclusivity" - Pink Sheet, 19 March, 2012..

Though Teva and CRR once were allies in the mission to move Plan B over the counter, the emergence of generic competition in 2009 meant a class-wide OTC approval would jeopardize Teva’s commercial interests. In 2012 filings with the court, FDA and the Jerusalem-based company argued that competing firms should not be allowed to benefit from Teva’s studies in support of the drug switch, which FDA counsel said “would effectively hijack the sponsor’s proprietary information.”

But Korman points out that FDA’s letter denying CRR’s citizen petition said the agency had not made a final decision on granting Teva market exclusivity because the firm’s supplemental new drug application seeking the OTC switch ultimately was denied by Sebelius.

Further, the judge notes that, rather than appealing the sNDA denial, Teva “claims to be involved in ‘active dialogue with the FDA right now,’ and it has acquiesced in the suggestion that it could still appeal if the FDA should adhere to its position.”

“Under these circumstances, Teva’s position will not be affected whether the case is decided in favor of the FDA or the plaintiffs – in either case, it will not enjoy exclusivity,” Korman says.

A Teva spokeswoman said the company is reviewing the court’s decision and declined to comment.

Though the company asserted its commercial interests, it was not a party to the litigation between CRR and FDA. Teva has the opportunity to initiate an appeal, but CRR Senior Counsel Janet Crepps said that strategy seems unlikely to succeed

“The judge in effect said that [Teva’s] entire application to be a party in the case was flawed because they weren’t actually taking a position in the case and they weren’t asking for any relief,” Crepps said. “That’s totally contrary to the idea of when someone can intervene in a case.”

Retail Cost Concerns

On an April 5 media call, advocates for OTC emergency contraceptives were optimistic that an appeal by the government likewise would find little traction.

“We don’t know right now any information about what the plans are, but it’s hard to imagine that an appeal would receive any more of an audience than these 10 years of litigation have produced,” said Susannah Baruch, interim president and CEO of the Reproductive Health Technologies Project.

Participants on the call acknowledged that more work remains in expanding access to emergency contraception for all women of reproductive age. For example, out-of-pocket costs remain a concern, with a dose of Plan B One-Step currently priced around $50 and Next Choice and other equivalents typically around $40.

Advocates said those prices are too high for many younger consumers to afford. And while the Patient Protection and Affordable Care Act dictates that FDA-approved contraception is to be fully covered by insurance, OTCs are excluded Also see "Physician Group Support Boosts OTC Contraception Chances" - Pink Sheet, 3 December, 2012..

Cora Collette Breuner, one of the lead authors of the American Academy of Pediatrics’ November 2012 policy statement in favor of broader emergency contraceptive access, said on the call that she hopes state Medicaid boards will continue to cover levonorgestrel products as they move to nonprescription sale, “like they fund many over-the-counter medications for our patients.”

Court Ruling Compels Emergency Contraceptives Over The Counter

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