RegBlog

RegBlog

Learning from the FDA’s Plan B Fiasco

| Dec 11, 2013 | Opinion

In  2001, a group of private citizens, public health groups, and medical organizations petitioned the Food and Drug Administration (FDA) to approve nonprescription status for the emergency contraceptive Plan B and its generic cousins.  Under the Food, Drug, and Cosmetic Act, the FDA’s decision was supposed to turn on whether these drugs could be taken safely and efficaciously without the assistance of a licensed health professional.  Instead, an investigation by the Government Accountability Office (GAO) and fact-finding by the district court handling litigation over the controversy made clear that the FDA bowed to political pressure, first by delaying any decision as long it could and then by being as stingy as possible in granting nonprescription access to emergency contraceptives.

Over a twelve-year period, the agency resorted to extreme measures to avoid answering the statutorily dictated question: whether women and girls could safely and efficaciously take emergency contraceptives without permission from a licensed health professional.  With every new stratagem, the agency dug itself deeper into an administrative law hole: inventing policies on the fly, grasping at tangents, shrouding the truth, and cowering before illegitimate political demands.

No wonder that a district judge hearing a challenge to the FDA’s decision making finally had had it with the FDA’s shenanigans and ordered the agency to make emergency contraception available without restriction to all women and girls of child-bearing age. No wonder that the FDA was left with paltry legal arguments in its (now-abandoned) appeal of the trial court’s decision.  No wonder that the whole episode left observers inside and outside the agency shaking their heads over the sad retreat of a proud institution.

Pharmacy purchase

The FDA’s Plan B saga teaches us two lessons.  The first lesson from this long-running fiasco is that courts must sometimes depart from the usual script for judicial review of regulatory decisions to meet the fundamental requirements of administrative law.  Several departures from ordinary judicial review processes contributed to unmasking the agency’s violations of administrative law.  These departures included ordering discovery of records the agency claimed were subject to the deliberative process privilege, ordering depositions of agency officials (including two former commissioners of the FDA) regarding their decision making, and ordering the agency to execute a decision the court found was mandated by the agency’s own record.

The striking and legally relevant facts revealed by judicial discovery should encourage a reconsideration of the settled rule that ordinarily courts should not stray beyond the administrative record in reviewing agency action and certainly should not, to use the standard formulation, “probe the mental processes” of the decision maker.  Unless courts are sometimes willing to depart from the usual plot line for judicial review, they will be unlikely to uncover and remedy the most serious violations of administrative law.

Second, in light of the combined outrages of an agency dissembling about the actual basis for its decision and obscuring improper political intervention, we must reconsider the conventional wisdom that as long as an agency has some legally relevant and factually sound reason for its action, it does not matter whether that is the true reason and the true reason is simple politics.

This understanding comes from the D.C. Circuit’s widely discussed 1981 decision in Sierra Club v. Costle.  In that case, the court held that ex parte discussions with White House personnel (including the President) about a rulemaking not only need not be disclosed, but also could “direct an outcome that is factually based on the record, but different from the outcome that would have obtained in the absence of Presidential involvement.” So long as the public record compiled for the rule actually supported the ultimate decision, the rule could stand. Applying this holding to the FDA’s handling of Plan B suggests that the FDA was within its rights in offering a technically framed justification for its decisions that did not reflect its real motivation and in giving in to political demands.

The Plan B episode provides an occasion to reconsider Sierra Club’s license for prevarication and its privileging of politics. If it is perfectly fine for an agency to cloak political motivations in technical reasoning, then the FDA’s dissembling on Plan B was just administrative business as usual.  But the FDA’s decision making on Plan B would not have become national news, and would not have led to such a stern rebuke from the district judge, if the matter had involved ordinary agency misbehavior.  The negative public and judicial attention was due to the perception that the FDA had acted in bad faith by stonewalling emergency contraception for deeply political reasons.

Allowing an agency to hide the real reasons for its decisions as long as it comes up with a solid technical reason for them perverts the place of expertise in administrative law.  Independent expertise becomes a mere means to the end of surviving judicial review rather than being the very purpose of turning to an administrative agency in the first place.  The charade embraced by Sierra Club v. Costle undermines the fundamental rationale for administrative agencies.  In order to survive judicial review based on the record and explanation it has compiled, an agency will need to do a lot of work – work that simply masks the agency’s real motivations.  As parents teach their children, lying is really hard work.

The Sierra Club charade also has unhealthy consequences for administrative agencies themselves.  Expertise and reason giving become a way to survive judicial review rather than anchoring agency identity and culture. This shift wholly disrespects the professional integrity of an agency’s experts, who are made to profess reliance on technical matters even where doing so is part of an elaborate sham.  In the Plan B matter, the elevation of politics over expertise and dissembling over truth telling led to the resignations of high-level decision makers and to the widespread sense within the agency that the scientific judgments of the professional staff were beside the point. These are not the hallmarks of a healthy organization.

More broadly, condoning an agency’s dissembling about the real reasons for its decisions makes the entire administrative process one big lie.  Requiring an agency to compile an administrative record and then to explain its decision making in light of that record becomes an elaborate – not to mention time-consuming, expensive, and cynical – charade if that explanation only serves to inoculate a decision based on unstated reasons from judicial invalidation.

Many of the reasons for objecting to a license for dissembling on the part of agencies also apply to a license for political meddling.  The compilation of a thick, fact-intensive, intricately-detailed administrative record is a monument to futility if the real reasons for an agency decision are, say, that the President believes in reproductive choice (or doesn’t) or prefers clean air (or doesn’t).  The displacement of the scientific views of an agency’s professional staff with political leanings upsets the culture of expertise that defines the modern administrative agency.  The introduction of political reasons into the administrative law structure also greatly unsettles the expectation that like cases will be treated alike unless there is a good reason to treat them differently. In future cases, perhaps the agency will ignore a prior, politically charged decision precisely because it was politically charged, thus introducing a whole new cycle of political calculations into the next generation of agency decisions.

Perhaps we are seeing such a harmful cycle play out now, in the context of the cases challenging the “contraceptive mandate” under the Affordable Care Act.  The Supreme Court has accepted two of these cases, Sebelius v. Hobby Lobby and Conestoga Wood Specialties Corporation v. Sebelius, for review during this Term.  In both cases, the U.S. Solicitor General has simply conceded the plaintiffs’ assertion that emergency contraceptive drugs interfere with implantation of a fertilized egg.  The Solicitor General’s concession cites an FDA website that itself quotes the FDA-mandated label for these drugs.  The FDA required this label over the demurral of the drug sponsor and despite a lack of evidence of an effect on implantation.  The FDA continued to require this label over the years despite growing evidence of a lack of such an effect.  The FDA made these decisions during the troubled years in which its political machinations prevented ready access to emergency contraceptives.

It is not fanciful to suppose that the political meddling on Plan B is bearing sour fruit in the current controversy over the contraceptive mandate.  The implications of allowing politics and prevarication under Sierra Club v. Costle go well beyond the Plan B saga.  The role of the President in agency decisions has deepened and intensified with each recent administration, regardless of party.  The President now openly countermands decisions that were once thought solidly within an expert agency’s remit. Proposals forwarded to the White House for regulatory review are revised – sometimes almost beyond recognition – by a shadowy mélange of political operatives, White House economists, career staff in other agencies, Cabinet members, and others. Other proposals languish at the White House indefinitely, with no public explanation of their status. In a world where the White House political apparatus has come to run the regulatory apparatus of the U.S. government, it is past time to reconsider the judicial precedent that condones this state of affairs and the dissembling that attends it.

Tagged: , , ,

    Related Posts