Federal Court Orders FDA to Approve OTC Emergency Contraception Without Restrictions, Describes Intervention by Secretary Sebelius as “Unprecedented” and “Politically Motivated”

April 8, 2013

By Etan J. Yeshua & Kurt R. Karst –      

Last Friday, a federal district court judge, in a 59-page decision, ordered FDA to make the emergency contraceptive PLAN B (levonorgestrel) available Over-the-Counter (“OTC”) and without age restrictions.  In doing so, Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York strongly criticized Kathleen Sebelius, the Secretary of Health and Human Services, for “politically motivated” and “unprecedented intervention” in FDA’s decision-making.

Although FDA concluded in 2011 that PLAN B was safe for OTC sale without restrictions, the Agency was overruled by Ms. Sebelius who instructed FDA to approve the drug for sale only at pharmacies and health clinics, to require that it be kept behind the counter, and to prohibit sale to women 16 and under without a prescription.  On Friday, Judge Korman struck down all of these restrictions as arbitrary and capricious.

In a scathing opinion that reproached Secretary Sebelius for acting in bad faith and for allowing political considerations to trump the expertise of FDA’s scientists, Judge Korman stressed the importance of evidence- and science-based decisions by government regulators entrusted with safeguarding the public health. 

“[A] decision . . . that should be made by the FDA.”

PLAN B, the first emergency contraceptive drug, was approved by FDA for prescription use in 1999.  The drug product consists of two pills to be taken 12 hours apart in order to prevent pregnancy.  Due in part to the controversial social and ethical implications of the drug’s availability, what was already an interesting case study in administrative law has become a 14-year saga of court battles, prescription-to-OTC switches, and a Citizen Petition that some, including Judge Korman, say was denied on political rather than sound medical grounds.

In 2001, more than 60 family planning and health organizations (the plaintiffs in the present case) submitted a Citizen Petition (Docket No. FDA-2001-P-0123) to FDA to allow PLAN B (and its generic equivalents) to be sold OTC.  FDA denied the Citizen Petition in 2006 and instead approved PLAN B for OTC sale only to women 18 and over.  FDA further conditioned the OTC approval on certain restrictions at the point of sale: the drug could only be sold in pharmacies and only to consumers who demonstrate proof of age with government-issued identification.  It remained available to women 17 and younger only by prescription. 

When the petitioners sought judicial review of FDA’s decision in 2006, Judge Korman, in 2009, vacated FDA’s Citizen Petition denial because of the “political considerations, delays, and [FDA’s] implausible justifications.”  (See our previous post here.)  However, seeking to maintain the integrity of FDA’s decision-making process and of the federal separation of powers, Judge Korman did not order FDA to make PLAN B available as an OTC drug.  He instead remanded for FDA to reconsider: “It was my view that the decision whether to make PLAN B available without a prescription regardless of age was one that should be made by the FDA, to which Congress had entrusted the responsibility, and not by a federal district judge.”  FDA did not appeal the decision.  Instead, FDA announced that the Agency would, “upon submission and approval of an appropriate application,” permit the sale of PLAN B without a prescription to women 17 years of age and older.  (See our previous post here.)  (In a different case filed in 2007, the U.S. District Court for the District of Columbia dismissed an attempt to vacate FDA’s PLAN B approval – see our previous post here.)

A few years after Judge Korman’s initial decison, and while FDA was reconsidering the Citizen Petition, the holders of the NDA for PLAN B sought approval of a supplemental NDA (“SNDA”) for PLAN B One-Step, which consisted of the same active ingredient in the same dosage as PLAN B, but in a single pill.  In 2011, FDA determined that “Plan B One-Step should be approved for all females of child-bearing potential” without the age and point-of-sale restrictions.  Nevertheless, FDA Commissioner Dr. Margaret Hamburg announced that the Agency’s decision had been overruled by Ms. Sebelius.  (See our previous post here.)

In a highly unusual and surprisingly public move, Ms. Sebelius intervened and required FDA to apply the age and point-of-sale restrictions already in place for emergency contraceptives to PLAN B One-Step, saying that the SNDA lacked studies showing that young teenage women could understand the drug’s label in such a way that they would use the drug safely.  Only days later, FDA again denied the Citizen Petition.  The petitioners again filed suit, seeking injunctive relief requiring FDA to approve the OTC switch of PLAN B for women of all ages.  (A copy of the Complaint, as amended, is available here.)

Last Friday, Judge Korman issued a scathing opinion striking down FDA’s denial.  This time, however, patently frustrated by what he called the Agency’s “obstructions,” Judge Korman ordered FDA to grant the Citizen Petition and make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions.  (Copies of the various brief in the case are available here, here, here, here, and here.)

“[T]he agency action cannot be adequately explained in the record it compiled.”

Although the opinion faulted Ms. Sebelius for making an “election-year decision” regarding the SNDA (rather than deferring to FDA scientists who recommended full OTC approval), the government argued that Ms. Sebelius’ actions regarding the SNDA, and the studies submitted as part of the application, were outside the scope of the administrative record at issue and thus not properly reviewable.

Judge Korman acknowledged that his subject matter jurisdiction extended only to FDA’s denial of the plaintiffs’ Citizen Petition and not to Ms. Sebelius’ decision with regard to the SNDA for PLAN B One-Step.  However, he rejected the government’s argument that he was therefore foreclosed from reviewing documents and evidence related to the SNDA rejection.  First, Judge Korman found that the SNDA record was reviewable because FDA had itself included studies from the application in its review of the Citizen Petition. 

Second, he found that the government’s rationale for denying the petition was so weak that, even if evidence from the SNDA was outside the administrative record, he had no option but to look elsewhere for insight into the government’s decision-making process.  “[W]hen the agency action cannot be adequately explained in the record it compiled, the court’s consideration of evidence outside the agency’s ‘administrative record’ is not only warranted . . . but necessary to a meaningful judicial review of the agency’s action.”

Finally, when the government pressed this argument further by claiming that Judge Korman had not been granted the “right of reference” to studies in the SNDA by the drug manufacturer, Judge Korman evinced further frustration with the government, whose brief apparently cited “a 20,000+ word statutory section… without any pincite.”  “Judges are not like pigs, hunting for truffles buried in briefs,” he wrote, quoting a 1991 decision from the Seventh Circuit.

“The decision that the agency was forced to make, contrary to its own policies and judgment, is not entitled to deference.”

Because Judge Korman considered the Citizen Petition denial to be a direct result of Ms. Sebelius’ intervention in the SNDA process, he refused to give the petition denial the standard deference afforded to regulatory decisions.  “The decision that the agency was forced to make, contrary to its own policies and judgment,” he wrote, “is not entitled to deference.”  Judge Korman cited Ms. Sebelius’ “lack of scientific expertise” and noted that “most of those who hold that position [of Secretary of HHS] are not qualified to serve as Commissioner of the FDA.”  As such, Judge Korman found that the traditional grounds for affording regulatory decisions deference were not applicable here.  Moreover, he questioned whether Ms. Sebelius had the authority to overrule the FDA Commissioner, as she (the Commissioner) “does not serve at the pleasure of the Secretary, and she cannot be removed from office by the Secretary.  Only the President has the power to do so.”

Judge Korman added that FDA’s denial of the Citizen Petition requires special scrutiny because it involves the “constitutional right to obtain and use contraceptives” and because the decision was based on significant and unexplained departures from standard FDA practice.

“Unexplained departures from a number of established policies.”

The government’s decision-making with regard to the Citizen Petition was found arbitrary and capricious in that it departed from “established policies and practices followed by the FDA.”  For example, Ms. Sebelius’ decision to restrict PLAN B and PLAN B One-Step to behind-the-counter sale upon proof of age was struck down as an exercise of authority that FDA does not possess:  “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.’”   

With regard to the minimum-age restrictions, Judge Korman noted that FDA has long relied on labeling to address age-related safety concerns about OTC drugs; warnings about use of certain drugs in children and directions for use in children of certain ages are common on OTC drug labels.  As such, Ms. Sebelius’ claim that cognitive differences between older and younger women requires additional label comprehension studies was found to “reflect[] the fact of her lack of familiarity with, or her willingness to ignore, the policy of the FDA in dealing with these concerns.”  Indeed, Judge Korman noted that Ms. Sebelius’ rationale, if applied to all drugs, could gut the entire OTC regulatory scheme: “if the ‘cognitive differences’ to which she referred affected the ability of the youngest adolescents to understand the label and use the drug appropriately, then it would be impossible for any drug to be approved for over-the-counter sales without a prescription.”

Moreover, Judge Korman described Ms. Sebelius’ “unprecedented intervention” in overruling FDA as “the most significant departure from agency practice.”  He noted that Ms. Sebelius not only failed to describe any harm that would arise from affording young women access to the drug, but had done so in the course of overruling the Agency “in an area [i.e., drug approval] which Congress entrusted primarily to the FDA… and which fell within the scope of the authority… delegated to the Commissioner.”  Ironically (in light of this intrusion into regulatory affairs), when faced with the argument that it had explicitly told the manufacturer that label comprehension studies were not required for the SNDA, the government replied that Ms. Sebelius was not present at the meeting where FDA agreed to waive this requirement.  Judge Korman dismissed this defense of Ms. Sebelius as “an excuse offered by the minyan of attorneys representing her.”   

Given what he described as these unexplained departures from standard FDA practice, Judge Korman concluded that the government’s action with regard to the Citizen Petition was arbitrary and capricious, that “[t]he motivation for the Secretary’s action was obviously political,” and that “[t]he reasons she provided are so unpersuasive as to call into question her good faith.”

“Administrative agency filibuster”

FDA has 30 days (from Friday, April 5) to approve levonorgestrel as an OTC emergency contraceptive without age or point-of-sale restrictions.  Although the government requested that it be allowed to initiate administrative rulemaking proceedings in the matter, Judge Korman denied the request.  He cited FDA’s previous decision not to commence such proceedings despite “eating up eleven months, 47,000 public comments, and hundreds of thousands, if not millions, of dollars” in arriving at the decisions.  In addition, FDA’s delays in responding to the Citizen Petition amounted to an “administrative agency filibuster” which, together with the “bad faith that has permeated consideration of the Citizen Petition, not to speak of the Plan B Sponsor’s applications, should rule out such relief here.”

The government has not yet indicated whether it intends to appeal Judge Korman’s decision.