Tummino v. Hamburg - 936 F. Supp. 2d 162 (E.D.N.Y. 2013)

Rule:

Though the agency's decision is unfettered at the outset, if it announces and follows—by rule or by settled course of adjudication—a general policy by which its exercise of discretion will be governed, an irrational departure from that policy (as opposed to an avowed alteration of it) could constitute action that must be overturned as 'arbitrary, capricious, [or] an abuse of discretion' within the meaning of the Administrative Procedure Act.

Facts:

Plan B and Plan B One-Step are emergency contraceptives that can be taken to reduce the risk of pregnancy after unprotected intercourse. Even for women 17 and older, Plan B can only be purchased at a pharmacy and required government-issued proof of age. Plaintiffs, organizations and individuals concerned with women’s health, as well as minors and their parents, sought to expand the availability of Plan B and all emergency contraceptives. The plaintiffs challenged the FDA’s denial of a citizen petition seeking the over-the-counter access to Plan B for women of all ages, alleging that such denial was arbitrary and capricious because it was not the result of reasoned and good faith agency decision-making but of overwhelming political pressure underlying the agency’s actions. 

Issue:

Under the circumstances, should the citizen petition seeking over-the-counter access to Plan B for women of all ages be granted?

Answer:

Yes.

Conclusion:

The court held that the decisions of the Secretary with respect to Plan B One-Step and that of the FDA with respect to the Citizen Petition, which it had no choice but to deny, were arbitrary, capricious, and unreasonable. The court noted that the denial of the Citizen Petition was accomplished by unexplained departures from a number of established policies and practices followed by the FDA. Moreover, the obstructions in the path of those adolescents in obtaining levonorgestrel-based emergency contraceptives under the current behind-the-counter regime have the practical effect of making the contraceptives unavailable without a doctor's prescription. The FDA has engaged in intolerable delays in processing the petition. The plaintiffs should not be forced to endure, nor should the agency's misconduct be rewarded by, an exercise that would permit the FDA to engage in further delay and obstruction. Accordingly, the FDA denying the Citizen Petition was reversed, and the case was remanded to the FDA with the instruction to grant the Citizen Petition and make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within thirty days.