June 11, 2013

The Obama Administration’s Plan B for Plan B: Compliance, or Defiance?

The Obama Administration’s announcement that it will comply with a district court’s order that it make emergency contraceptives available to all women and girls without a prescription comes as a welcome development in a long-running administrative-law fiasco. But the Administration’s specific suggestions as to how it will set things right, set forth in letters sent yesterday to the district court and to the citizen petitioners who originally asked for nonprescription access to emergency contraceptives, are inadequate in several respects.

First, under the government’s approach, we will all have to wait for Teva Branded Pharmaceutical Products R&D, Inc. — the sponsor of the one-pill emergency contraceptive, Plan B One-Step — to submit a new application asking for full over-the-counter status for its product before anything can happen to implement the court’s ruling. The government’s letter to the court announcing its compliance with the court’s ruling, and its letter to the citizen petitioners announcing its granting of their petition, set forth no deadline within which Teva must submit a new application. For all we know, Teva is uninterested in submitting such an application. As the government revealed in the district court proceedings, 99 percent of Teva’s market is covered by the application the FDA approved in April of this year. Why should Teva want more? Perhaps it is satisfied with what it has. In any event, nothing in the government’s “acquiescence” requires any action at all from Teva, and thus the government’s actions are utterly dependent on the independent and unpredictable actions of a private entity. This alone should make the government’s proposed “compliance” with the court’s order unacceptable.

Second, in its letter to the court, the government says that the FDA has “invited” Teva to “promptly submit” a supplemental new drug application with proposed labeling that would permit Plan B One-Step to be sold without a prescription or other point-or-sale restrictions. But we don’t know exactly what the government’s letter to Teva says. A previous letter exchanged between the government and Teva, read aloud by the district court judge in a hearing on the government’s motion to stay his order, suggested that the FDA had asked Teva to submit only very limited studies in a new request for over-the-counter status for Plan B One-Step. The FDA’s new “invitation” to Teva could very well contain some such limitation. We don’t know; the government hasn’t made the letter public. It also hasn’t made the other letters exchanged between it and Teva public. Unless and until the letters are made public, we simply won’t know if any private deals have been struck between this public agency and this private company, and thus we will not know if the public interest is being adequately served.

Third, the government has not yet decided whether Teva will be granted marketing exclusivity for its product. The FDA had previously granted Teva three years of exclusivity based on its conclusion that the studies Teva submitted with its latest supplemental new drug application were “essential” to its approval of over-the-counter status for this drug for girls 15 and older. But the finding that these studies were “essential” itself conflicts with the district judge’s factual findings that Plan B One-Step was approvable for over-the-counter status without the new studies. The FDA has not directly challenged the district judge’s factual findings. Even so, the government’s letters to the district court and to the citizen petitioners indicate that the government continues to maintain that the latest studies on Plan B One-Step meaningfully distinguish this product from Plan B and its generic equivalents. Without a promise from the government that it will abandon its baseless assertion that the new Teva studies are “essential” in proving that Plan B One-Step is safe and effective for women and girls of all ages without a prescription, it appears that the government will continue to give legal effect to the very factual premises that the district court found arbitrary, capricious, unreasonable, and held in bad faith. This would not be compliance with the court’s order; it would be continuing defiance of it.

Fourth, the government continues its bizarre insistence on not permitting over-the-counter status for the “two-pill” version of Plan B and its generic equivalents. In so doing, the government invokes the district court’s statement that "if the FDA actually believes there is any significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one-pill product." Without elaboration, the government — both to the court and to the citizen petitioners — refers to its briefs to the district court in continuing to assert that “there are significant differences between Plan B and PBOS under FDA’s regulations and the Federal Food, Drug, and Cosmetic Act.” But surely, the district court must have intended that the FDA’s “actual[] belie[f]” be based upon actual, demonstrated factual differences between the drugs — meaningful and “significant” differences that would suggest that it would be possible safely and effectively to take Plan B One-Step without a prescription but not possible safely and effectively to take Plan B and its generic equivalents without a prescription. The evidence before the district court pointed in exactly the opposite direction, which is why the district judge (at pages 42-48 of his April 5 slip opinion) comprehensively rejected the grounds the government had relied upon to establish such a difference between the two products. The only “briefs” the government filed after the district court’s order did not take issue with any of the district court’s factual findings. The government thus must be, as its letters indeed suggest, relying on some legal distinction between these products in arguing that they are significantly different. To be sure, the products are technically legally different because one product requires one pill and the other requires two pills. But it only stands to reason that the district court was looking for something more than this already-obvious fact in inviting the government to explain why it “actually believes there is any significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one-pill product." The government has not provided the explanation the district court was apparently looking for, and therefore the government has not justified its continuing bright-line distinction between Plan B and Plan B One-Step.

Fifth, the government also tries to distinguish Plan B from Plan B One-Step by saying that there are “fewer data available” on the actual use of Plan B than there are on Plan B One-Step. Granted, but FDA career staff found ten years ago that the data on Plan B that existed then were sufficient to move Plan B to full over-the-counter status; only improper political interference prevented a switch then to over-the-counter status for Plan B. “Fewer data” does not mean insufficient data. The government’s attempt to elide this fact, and to continue to distinguish Plan B from Plan B One-Step based on the proportion of studies available regarding each rather than to admit the sufficiency of the studies it has possessed for over a decade, again evinces defiance rather than compliance.

All in all, then, yesterday’s letters to the district court and the citizen petitioners are a welcome step in the right direction, but they do not go far enough in granting access to emergency contraceptives for women and girls of all ages. An important aspect of the original citizen petition, which the FDA is now purporting to grant, was its request for over-the-counter access to the generic equivalents to Plan B. As the government’s plan stands, there is no guarantee that petitioners will get full over-the-counter access to any generic emergency contraceptives, and there is reason to believe they will be denied it. Judge Korman should make sure, before he finds that the government’s overture reflects true compliance with his order, that women and girls of all ages will have access to generic emergency contraceptives.

The Washington Post reprints the government's letter, here. 

Lisa Heinzerling, CPR Member Scholar; Professor, Georgetown Law. Bio.

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