Plan B judge pushes back against Justice Department and FDA

Federal District Court Judge Edward Korman filed a scathing memo Wednesday night that criticized the Obama Administration's Monday proposal for meeting Korman's orders on making morning-after contraception available to women of all ages without a prescription.

For more than a decade, women's health groups have fought a regulatory and legal battle to make emergency contraception available at the lowest possible price without a prescription.

Teva Pharmaceutical Industries, Ltd., whose Americas headquarters is in Montgomery County, is at the middle of the dispute because it makes Plan B One-Step, a one-pill version. Teva used to make Plan B, which is a two-pill version, but no longer does so because there are enough generic competitors to drive down the price.

Other people and groups, including Presidents Bush and Obama (who has two daughters) are wary - or completely opposed - to allowing anyone to buy such products off the shelf like a pack of gum.

Korman has ordered the government to do that, with only a few possible outs. The government, sensing it would lose its overall case, was trying one them with Monday's letter. It said it would allow Teva's Plan B One-Step and one-pill generic versions - but possibly only after giving Teva a three-year period of exclusivity.

The women's groups want as many safe-and-effective versions on the market as possible, to reduce costs for poor women.

(Whether Teva would play in that environment was discussed in Wednesday morning's PhillyPharma, link here.)

"The real problem relating to cost deals with the potential period of marketing exclusivity that the FDA may grant to Teva," Korman said in his memo.

Korman challenged FDA Commissioner Margaret Hamburg to follow normal FDA procedures, her own written opinions and the 27-1 advisory committee vote that recommended approval for over the counter use. He again questioned the FDA assertion that Teva's submission of studies on whether women understood the proper use was real or really necessary. He also poked Teva, for riding the legal coattails of women's groups, up until it made sense to jump to the government's side.

"In sum, I urge the FDA to carefully consider whether the actual use study is truly essential to its approval of Plan B One-Step for over-the-counter marketing," Korman wrote at the end of his six-page memo. "A three-year grant of marketing exclusivity will only burden poor women. This unfortunate result is difficult to reconcile with the policies underlying the statutory provisions governing marketing exclusivity, which, according to both the FDA and Teva, are intended “to encourage and reward drug

manufacturers who devote the time and expense to clinical trials necessary to approve changes to a drug product.” Whatever expense Teva incurred, it did not mount a legal challenge to the FDA’s denial of its SNDA [Supplemental New Drug Application]. Instead, it entered into an agreement with the FDA which allowed it to market Plan B One-Step to women fifteen and over, thus leaving in place burdensome point-of-sale and photo identification requirements. It is only because of the extraordinary efforts by the plaintiffs in pursuing their Citizen Petition that Teva is able to seek approval of an SNDA that will permit it to market its product with no point-of-sale or age restriction. Such approval, if given, will be nothing more than a reward to Teva for playing along with the defendants’ efforts to maintain their legally and scientifically unjustified restrictions on the marketing of levonorgestrel-based emergency contraceptives. It is the plaintiffs, rather than Teva, who are responsible for the outcome of this case, and it is they, and the women who benefitted from their efforts, who deserve to be rewarded."