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Federal Regulations Advisor Insight and Commentary on U.S. Government Regulatory Affairs

Court Requires FDA to Grant ‘Plan B’ OTC Status – Authority Issues

Posted in Agency Authority, Constitutional Issues in Regulations

A judge of the United States District Court for the Eastern District of New York has ordered the Department of Health and Human Services (HHS) Food and Drug Administration (FDA) to make “Plan B” – the post-intercourse, pre-fertilization contraceptive “morning after” pill – available over the counter (OTC) rather than by prescription to individuals under the age of 17.  At the forefront of this longstanding debate are medical, scientific, political, social, and moral issues – all of which will continue to be strongly debated.  Buried deep in the lengthy court decision, however, is a fundamental principle long ago stated:  an official cannot exercise an authority delegated without reservation to a subordinate unless the official alters the delegation.  In Tummino v. Hamburg, the application of this principle poses its own unique problems of administrative law.

Background:  Plaintiff minors and their parents, and organizations and individuals concerned with women’s health issues, sought to expand the availability of Plan B under the Food, Drug, and Cosmetic Act (FDCA) – and the later version Plan B One Step – from prescription and limited behind-the counter availability to “over-the-counter” (OTC) availability for anyone to purchase, no questions asked.  In this long, intensive regulatory and litigation process, plaintiffs asserted that the FDA’s denial of an OTC status (through a citizen petition) was arbitrary and capricious because it was not the result of reasoned and good faith agency decision-making based on science.  The complex of applications, petitions, and jurisdiction under substantive FDCA need not be considered here.

Tummino I:  The district judge previously concluded that overwhelming evidence of Bush White House political pressure required the court to vacate the FDA’s denial of the citizen petition and remanded the decision to FDA to exercise discretion without impermissible political intrusion.  The court directed the FDA to make Plan B available to 17-year-olds without a prescription because the same evidence relied on by the agency to support OTC access to the drug by 18-year-olds applied equally to 17-year-olds (which the FDA ultimately conceded).

Government’s Response:  The FDA did not approve any change for three years but did so after the Commissioner had “reviewed and thoughtfully considered the data, clinical information, and analysis provided.”  The Obama Administration Secretary of Department of Health and Human Services (HHS) overruled that decision, concluding, “that the data submitted for this product do not establish that prescription dispensing requirements should be eliminated for all ages.”  This pronouncement made it impossible as a practical matter for the FDA to approve the citizen petition, because the petition likewise did not include such data.  The FDA then denied the petition.  President (POTUS) Obama asserted that he was not involved in the decision, but endorsed the HHS decision on yet a different basis, which probably added confusion to the issues.

Tummino II:  In a new challenge, the court found, for a variety of reasons, that the Secretary’s decision, and thus the FDA’s conformance with her instructions, must be vacated, and the court took the additional step of requiring the FDA to approve the petition to make a variant of Plan B available OTC without limitations based on age.  The scientific and medical evidence under the Administrative Procedure Act (APA) arbitrary and capricious standard of review of final agency action, and certainly the moral issues, ‘present’ volumes for evaluation.  Here, the core authority issue is present.

Two Principles:  The district court’s administrative law decision is founded on two core principles:

  1. an official cannot exercise an authority delegated without reservation to a subordinate unless the official alters the delegation, and
  2. an irrational departure from an announced policy (as opposed to an avowed alteration of that policy) could constitute arbitrary and capricious action, and an abuse of discretion.

The district court did not analyze these principles in a structured way to hold only that which was necessary to decide the case, however, but inverted them, deciding irrational departure from policy before deciding that the Secretary had no authority to make a decision, which could have obviated the need to reach the policy departure issues.  While a court may be thorough and provide multiple bases for its decision, the structure the court used here is not one of alternative holdings, but of reversing the issues.

Statutory Delegation:  In this instance, Congress has been both specific and ambiguous.  The relevant statutory provision, 21 U.S.C. § 393(d)(2), reads like many legislative delegations of authority, providing that the “The Secretary, through the Commissioner [of FDA], shall be responsible for executing [the FDCA]” — “providing overall direction to the [FDA] and establishing and implementing general policies respecting the management and operation of programs and activities of the [FDA; … and performing such other functions as the Secretary may prescribe.”  Some circularity of structure exists when the Secretary prescribes other functions to the Secretary, acting through the Commissioner.  The new drug provisions of 21 U.S.C. § 355 vest limited authority directly in the Commissioner, and most authority in the Secretary.  Although the court found much merit in the statute for precluding the Secretary from acting, serious doubt exists.

“Regulatory” Delegation:  The district court found that the Secretary had delegated the Plan B new drug decision in the FDA, and, therefore, rejected the Secretary’s rejection of the FDA decision and requirement that the FDA take her point of view.  On the first principle of delegation, the court cites FDA Staff Manual Guide § 1410.10, which provides that “The Secretary … has redelegated to the Commissioner [of FDA] … all authority” across 42 broad enumerated categories of functions, including approval of new drugs.  From this encyclopedia, the Secretary reserved authority to approve FDA informal regulations establishing procedure or that “[p]resent highly significant public issues involving the quality, availability, marketability, or cost of one or more foods, drugs, cosmetics, medical devices, or other subjects of regulation.”  Nowhere did the Secretary reserve authority to approve new drugs or conditions.  Thus far, the court appears to be on mark.

Unanswered, however, is the substantive authority of the FDA Staff Manual Guide.  The FDA Staff Manual Guide is not promulgated as a regulatory delegation; it appears to be no more than the construct of an internal directives system.  A regulation remains inviolate until altered by another regulation under the traditional teaching of Shaughnessy v. Accardi that an agency must follow its own regulations.  The FDA Staff Manual Guide, while published by the FDA, is less than a regulation – it is a policy statement.  This left the court with only irrational deviation from that policy statement as a basis for finding that the Secretary was unauthorized to direct the FDA, but the court does not delve into that depth.  The result might be the same, but might also be quite different.

Some question also exists as to whether such a “policy” comports with the original APA requirement that an agency publish in the Federal Register a statement of “the general course and method by which its functions are channeled and determined.”  The “directive system” many agencies use for delegations is opaque and fails the APA’s original transparency test and its progeny, today’s Freedom of Information Act (FOIA).  Delegations of authority belong in the Federal Register and even the Code of Federal Regulations, not in internal manuals.

Authority RevisitedTummino I & II, Bayou Lawn & Landscaping, and Noel Canning all recently have raised core agency authority issues.  The Department of Justice (DOJ) will be hard pressed not to appeal Tummino II to the United States Court of Appeals for the Second Circuit, and issue will likely be joined on authority, more than food and drug, and not the efficacy of Plan B.  DOJ and private practitioners constantly face issues of agency authority that require a thorough understanding of administrative law.

Rationality:  Had the court resolved the authority issue first, the court might not have reached the issue of whether the Secretary’s decision was rationale.  The court did, though, reject the Secretary’s rationales for not following FDA’s initial recommendation under traditional State Farm standards.  All this requires a far more detailed analysis of FDCA law – which is why rational basis analysis requires both administrative law and substantive law expertise.