Morning-after pill case: US court slaps FDA

In a judgment handed down on 23 March 2009, Justice Korman of the United States District Court has severely criticised the Food and Drug Administration ("FDA") for its politically-motivated stonewalling on approval of a "morning-after pill", Plan B, for non-prescription use. The judgment reveals a sorry tale of political interference and bureaucratic contortions, in an attempt to restrict the availability of a drug that is disliked by America's Religious Right.

Cases like this carry lessons for us all, and not only in America.

Plan B
Plan B is a highly-effective emergency contraceptive that works by stopping the release of an egg from an ovary. It may also prevent fertilisation or block the implantation of an embryo if fertilisation has already taken place. Used properly, it can reduce the likelihood of an unwanted pregnancy by up to 89 per cent, and it has no known serious or long-term side effects. As long ago as 1999, it was approved in the United States for prescription-only use, and it remains the only such drug legally available in the US.

Plan B is time-sensitive, and most effective if taken within 24 hours of sexual intercourse; it is not effective beyond 72 hours. Thus, such barriers as the need to obtain a prescription could easily increase the chance of an unwanted pregnancy.

The litigation
In Tummino et al. v. Torti (decided 23 March 2009), the plaintiffs were various organisations and individuals who advocated better access to emergency contraceptives, as well as parents and their children seeking access to them. The plaintiffs brought an action in the US District Court requesting judicial review of a decision by the Food and Drug Administration ("FDA") – which had denied their Citizen Petition lodged in early 2001. The Citizen Petition sought that the FDA make Plan B available without a prescription to women of all ages. Such an application to switch from prescription use of a drug to non-prescription use is known as a "switch application" or an "over-the-counter [or OTC] switch".

The FDA considered the Citizen Petition concurrently with a series of proposals by the manufacturers/marketers of Plan B, who sought that it be approved for non-prescription sale to all women, then (when that failed) to all women over 16, then (when that also failed) to all women over 17.

In the event, the FDA made a decision in 2006, after court proceedings had already commenced, to approve non-prescription sale to women over 18. The agency rejected all other petitions or proposals. Although its own research and internal consideration suggested that Plan B was safe for use by 17-year-old women without the need for a prescription, the FDA decided to restrict non-prescription availability to 18-year-olds and older, justifying this with concerns about enforcement issues (i.e., issues relating to age identification).

The plaintiffs took action under the Administrative Procedure Act, which enables the judicial review of administrative decisions that are alleged to be "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." In proceedings before Justice Korman, they argued that the relevant decisions by the FDA were arbitrary and capricious, and should be overturned.

Findings
Justice Korman found that the FDA had repeatedly and unreasonably delayed issuing a decision on Plan B. The agency took five years to decide to deny the Citizen Petition after its tentative response in 2001. On two occasions, it took action to progress the issue only to facilitate confirmation of Acting FDA Commissioners whose Senate confirmation hearings had been held up as a result of the repeated delays. The first occasion involved the confirmation of Acting FDA Commissioner Lester M. Crawford, who froze the review process for seven months in 2005. In response to the delay, Senators Hillary Clinton and Patty Murray had decided to block Crawford's appointment until approval of Plan B for over-the-counter sale.

At that point, the Secretary of Health and Human Services promised that the FDA would act on Plan B by September 2005. After Crawford was confirmed by the Senate in July 2005, however, he reneged on the promise and delayed action for another eleven months.

When the FDA finally decided to approve non-prescription use of Plan B for women 18 and older, it did so only to facilitate the Senate confirmation of Commissioner Crawford’s successor, Acting FDA Commissioner Andrew C. von Eschenbach.

Throughout the process, the FDA departed in numerous ways from its normal practices. E.g., upper management, including the Commissioner, wrested control over the decision-making from staff who would normally issue the final decision on an OTC switch application; efforts were made to stack the Advisory Committee for Reproductive Health Drugs and the Advisory Committee for Nonprescription Drugs with pro-life appointees; the FDA’s denial of non-prescription access without age restriction went against the recommendation of the advisory committees; and the Commissioner – in response to political pressure – decided to deny non-prescription access to women 16 and younger before scientific review staff had completed their work. The enforcement concerns eventually cited by the FDA to restrict non-prescription access to the drug to 18-year-olds and over were held by the judge to be "fanciful and wholly unsubstantiated".

Outcome
Justice Korman determined that the FDA had acted in bad faith and in response to political pressure.

He ordered the FDA to reconsider its decisions regarding the Plan B OTC switch. He also ordered the agency to permit Barr Pharmaceuticals to market Plan B to 17-year-olds without a prescription. For two reasons, he was content to allow the FDA to make its own reconsidered decision on non-prescription access for women under 17. First, a change in leadership at the FDA suggested that it could now be trusted to conduct a fair assessment of the scientific evidence. Second, it was not appropriate for a judge, rather than the expert agency, to decide whether Plan B could be used safely by children as young as 11 or 12.

Comment
This tale of woe highlights the danger of political pressures on administrative agencies entrusted with decisions on controversial issues. Though the FDA's remit went no further than investigating whether Plan B could be used safely without prescription, its contortions and delays were in response to pressure from political leaders motivated by their moralistic disapproval of emergency contraception and (we can easily infer) a similar disapproval of adolescent sexuality.

Putting it more bluntly, the Bush administration acted at the behest of the Religious Right to pressure a key agency to act with manifest impropriety. Motivated by moralistic concerns, high-level political actors attempted with considerable success to frustrate women's access to effective emergency contraception. Very young women in the most need were those who were made to suffer.

The election of a new administration, headed by Barack Obama, may reduce the danger of more such events in the US, but it's always in the background. Furthermore, the lessons don't apply solely to the US. All countries, to varying extents, are well-stocked with religious moralists who wield political influence and see their missions as above the law. Such people are most unlikely to feel constrained by ideas of separating church and state.

We have plenty of reason to be vigilant, not only in the US, but anywhere where religious moralists seek to impose their preferred moral views by influencing state power. The Bush administration was merely an egregious example of a much wider, and ever-present, danger to good government.