Federal Court Orders FDA to Approve OTC Sales of “Morning-After Pill,” Finds Current Age and Point-of-Sale Restrictions to be Arbitrary and Capricious

Apr 11, 2013   

On April 5, 2013, Judge Edward R. Korman of the United States District Court for the Eastern District of New York found that the Secretary of Health and Human Service’s (“HHS”) decision to limit over-the-counter (“OTC”) purchases of the emergency contraceptive levonorgestrel (marketed under the name PLAN B and commonly referred to as the “morning-after pill”) to women 17 and older, and thereby requiring girls 16 and under to have a prescription for the pill, to be arbitrary and capricious. In so holding, Judge Korman ordered the FDA to make the pill available OTC to women and girls of all ages free of the numerous point-of-sale restrictions that currently exist. A copy of the Court’s Opinion in Tummino v. Hamburg can be read here.

I. Procedural Posture

The Court’s decision is the culmination of a twelve year battle between family planning organizations and the FDA regarding the OTC sales of levonorgestrel.

A. The approval of PLAN B for prescription use, the subsequent Citizen Petition and the manufacturer’s supplemental new drug applications

In 1999, the FDA first approved leveonorgestrel for prescription use. Two years later, in 2001, the plaintiffs in this case filed a Citizen Petition with the FDA seeking the agency to switch leveonorgestrel from prescription to OTC status for all ages. A copy of the 2001 Citizen Petition can be read here. The FDA denied the Citizen Petition in 2006. The FDA’s denial can be read here.

Concurrent with the consideration of Citizen Petition, the FDA considered several supplemental new drug applications (“SNDA”) submitted by the drug’s manufacturer. The first SNDA sought OTC access to the drug for all ages. This SNDA was denied by the FDA. Subsequent to this denial, the manufacturer filed a second SNDA seeking OTC access for women 16 and older. However, “despite nearly uniform agreement among FDA scientific review staff that women of all ages could use Plan B without a prescription safely and effectively” the FDA rejected this application. See Tummino v. Torti, 603 F. Supp. 2d 519, 523 (E.D.N.Y. 2009).

The manufacturer then submitted a third SNDA, which proposed making Plan B available without a prescription to women 17 and older. “While FDA scientists and senior officials found that 17 year olds could use Plan B safely without a prescription, the FDA Commissioner determined that, because of ”˜enforcement’ concerns, Plan B would be  available  without  a  prescription  only  to women 18 and older.” Thus, the FDA approved the product’s OTC sale for women 18 or older while requiring the product be available to women 17 and younger by prescription only. In addition, despite the OTC approval for women over 18, the FDA placed several point-of-sale restrictions on the sale of the product including: 1) the drug could only be sold in pharmacies; and 2) the drug could only be sold to consumers who presented government-issued identification establishing proof of age. The petitioners sought judicial review of the FDA’s decision.

B. Tummino v. Torti (Tummino I): Plaintiffs’ first challenge to the FDA’s ruling on emergency contraception.

Subsequent to the FDA’ denial of the Citizen Petition, the plaintiffs sought judicial review in Tummino v. Torti, 603 F. Supp. 2d 519 (E.D.N.Y. 2009). In its complaint, the plaintiffs alleged that the FDA’s denial of its Citizen Petition, in light of the scientific evidence presented in the concurrent SNDAs, was arbitrary and capricious because it was not the result of reasoned and good faith agency decision-making.

In 2009, the Court agreed and vacated the FDA denial of plaintiffs’ Citizen Petition. In vacating the FDA’s denial, the Court found that the denial was the product of improper political influence and was arbitrary and capricious because the rationale for the agency’s decision departed from its own policies.

“To support a claim of improper political influence on a federal administrative agency, there must be some showing that the political pressure was intended to and did cause the agency’s action to be influenced by factors not relevant under the controlling statute.” Id. at 544 (quoting Town of Orangetown v. Ruckelshaus, 740 F.2d 185, 188 (2d Cir. 1984)). In holding that the decision was the by-product of political influence, the Court found that despite Advisory Committee and FDA scientists strongly recommending the drug for OTC without age restriction, the FDA Commissioner decided against unrestricted OTC access because of pressure from the White House. Thus, the Commissioner’s decision was influenced by outside political pressure and not factors relevant under the controlling statute. (It should be noted that a drug is considered suitable for OTC use when it is found to be safe and effective for self-administration and when its label clearly provides directions for safe use and warning regarding unsafe uses, side effects, and adverse reactions. See generally, 21 C.F.R. § 330.10(a)(4).)

In finding that the agency’s decision was arbitrary and capricious, the Court noted several departures by the FDA from its established policies and procedures. “The most glaring procedural departure was the decision to act against the Advisory Committee’s recommendation to approve the Plan B OTC switch without age restriction.” Tummino I, 603 F. Supp. 2d at 547. The Court went on to note that in every application in the last decade, the FDA has followed committee recommendations.

The Court noted that the FDA’s denial of the Citizen Petition departed from the agency’s general policies and procedures in at least four other respects. First, the FDA departed from policy when it placed additional members on its Advisory Committee for the purpose of achieving ideological balance. The Court noted that the “goal of ideological diversity does not aid the FDA in its obligation to examine the safety and effectiveness of a drug’s use in self-medication.” Secord, the Court found that the unusual amount of White House involvement in the decision was not the norm in the FDA’s OTC reclassification decision-making process. The third departure involved the timing of the agency’s decision to deny the Citizen Petition. The Court found that the decision regarding OTC status was made before the scientific review staff had completed its review of the manufacturer’s SNDA and without consultation with FDA scientists. The fourth departure was the agency’s refusal to extrapolate actual use study data from older age groups to the 16 and younger age group. The Court noted that the FDA routinely extrapolated such data when reviewing the safety and effectiveness of other forms of contraception.

However, the Court did not grant the plaintiff’s request to require the drug to be available OTC without restrictions for all age groups. Instead, the Court remanded to the FDA to reconsider its decision free from political influence and to “conduct a fair assessment of the scientific evidence.” The Court also ordered that the FDA make the drug available to 17 year olds OTC under the same point of sale restrictions that were currently in place for those 18 and over because scientific data was sufficient to support the safe use of the drug as an OTC for women 17 and older.

C. The reconsidered Citizen Petition, the 2011 SNDA, the FDA’s approval of OTC use and the subsequent reversal by the Secretary of HHS

Following the Court’s 2009 remand in Tummino I, the FDA once again undertook consideration of the plaintiff’s Citizen Petition for reclassification of leveonorgestrel from prescription to OTC status for all ages without point-of-sale restrictions. While the agency was reconsidering the plaintiff’s Citizen Petition, the drug’s manufacturer submitted a fourth SNDA seeking to allow OTC access to a single dose version of levonorgestrel for all ages.

On December 7, 2011, the FDA announced that “[b]ased on the information submitted to the agency, CDER [the Center for Drug Evaluation and Research] determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.” Thus, the FDA announced that “there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.” A copy of FDA Commissioner Hamburg’s statement can be read here.

However, that same day, HHS Secretary Sebelius overruled FDA Commissioner Hamburg and ordered the FDA to deny the SNDA. In her December 7, 2011 Memorandum to FDA Commissioner Hamburg, Secretary Sebelius concluded “that the data submitted for this product do not establish that prescription dispensing requirements should be eliminated for all ages.” More specifically, the Secretary noted “[t]he label comprehension and actual use studies submitted to FDA do not include data on all ages for which the drug would be approved and available over-the-counter. Yet, it is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age, which I believe relevant to making this determination as to non-prescription availability of this product for all ages.” A copy of the Secretary’s Memorandum can be read here.

While the Secretary’s denial of the SNDA did not directly apply to the plaintiff’s Citizen Petition, because the Secretary’s rationale for denying the SNDA was based on a lack of comprehension and actual use studies which were also lacking from the Citizen Petition, the practical effect of the Secretary’s decision was to force the FDA to once again reject the Citizen Petition. As a result, on December 12, 2011, the FDA again denied the Citizen Petition requesting OTC access to levonorgestrel for all ages without point-of-sale restrictions. A copy of the FDA’s 2011 denial can be read here. The petitioners sought judicial review of the FDA’s 2011 decision.

D. Tummino v. Hamburg (Tummino II)

Subsequent to the FDA’ denial of its Citizen Petition, the plaintiffs again sought judicial review. As in its original complaint, the plaintiffs again alleged that the FDA’s denial of its Citizen Petition, in light of the scientific evidence presented in the concurrent SNDAs, was arbitrary and capricious because it was not the result of reasoned and good faith agency decision-making. The plaintiffs further sought an order from the Court requiring the FDA to grant its Citizen Petition and make levonorgestrel-based emergency contraception available for all ages without point-of-sale restrictions. The Court agreed.

The Court reasoned as follows: “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.” (citing INS v. Yang, 519 U.S. 26 (1996)). Such was the case here.

In its biting opinion, the Court found that the Secretary’s decision in reversing the FDA Commissioner and denying the Citizen Petition was arbitrary and capricious for several reasons. The Court noted the unprecedented intervention of the Secretary in “overrul[ing] the FDA in an area which Congress entrusted primarily to the FDA, 21 U.S.C. § 393(d)(2), and which fell within the scope of the authority that the Secretary expressly delegated to the Commissioner.” See also FDA Staff Manual Guides, Vol.II – Delegations of Authority.

With respect to the Secretary’s determination that the studies submitted were insufficient because they did not include data on women of all ages, the Court found that the Secretary ignored the FDA’s previous waiver of such a requirement.  Moreover, the Court found that even if this could form an adequate basis for prohibiting OTC access for girls of all ages, the Secretary could not justify prohibiting non-prescription access for the age groups [14 and older] for which studies were presented.

The Court was even more critical with respect to the Secretary’s insistence on point-of-sale restrictions for OTC access. First, the Court noted that the Secretary could “not define any harm that could come from the use of levonorgestrel-based emergency contraceptives” by girls younger than 17. Second, the Court noted that even if such risks exist for an OTC product, “the policy of the FDA is to rely on labeling” and providing warnings and directions for use in at risk populations as opposed to implementing point-of-sale restrictions to address safety concerns. The Court went on to find that the “FDA’s authority over nonprescription drugs does not extend to restricting the point-of-sale distribution of drugs that have been found to be safe ”˜when used in the manner intended.’” (quoting American Pharmaceutical Ass’n v. Weinberger, 377 F. Supp. 824, 828 (D.D.C. 1974)). Thus the Court found that “[t]he Secretary’s edict to the FDA simply reflects the fact of her lack of familiarity with, or her willingness to ignore, the policy of the FDA in dealing with these concerns.”

Moreover, the Count found that the rationale and evidence upon which the Secretary relied in forming her decision was so weak that the agency could not adequately explain it in the administrative record itself. Thus, the Court found that FDA had to supplement the administrative record by considering the extra-record material and evidence, namely the studies and evidence submitted by the manufacturer in its 2011 SNDA. This evidence further supported the Court’s conclusion that the Secretary’s reversal of the FDA’s determination that levonorgestrel-based emergency contraceptives should be available OTC without point-of-sale restrictions was arbitrary and politically motivated.

In finding that the Secretary’s actions were arbitrary and capricious, the Court took the bold action of ordering the FDA to approve levonorgestrel as an OTC emergency contraceptive without any age or point-of-sale restrictions. In so ordering, the Court rejected the FDA’s request for remand to the agency so that the agency could initiate rulemaking. In a process the Court described as an “administrative agency filibuster,” the Court found that the “FDA has engaged in intolerable delays in processing the petition.” The Court noted that “one of the devices the FDA has employed to stall proceedings was to seek public comment on whether or not it needed to engage in rulemaking in order to adopt an age-restricted marketing regime. After eating up eleven months, 47,000 public comments, and hundreds of thousands, if not millions, of dollars, it decided that it did not need rulemaking after all.” The Count went on to state that “plaintiffs should not be forced to endure, nor should the agency’s misconduct be rewarded by, an exercise that permits the FDA to engage in further delay and obstruction.”

It is not yet known how, or whether, the FDA will appeal Judge Korman’s landmark decision.

The Court’s decision in this case highlights the importance that the judicial branch can and does play in allowing parties to engage in meaningful, and not mere perfunctory, judicial review of agency decisions. The attorneys of Fuerst, Ittleman, David,& Joseph, PL have extensive experience in the fields of food, drug, and cosmetic law and administrative litigation. For more information, please contact Fuerst Ittleman David & Joseph, PL at contact@fidjlaw.com.