Tuesday, March 24, 2009

OTC restriction for emergency contraception overturned

In 2006, the FDA approved the emergency contraceptive Plan B for over-the-counter sale for adults, but required that all minors obtain a prescription. Yesterday, a federal judge in Brooklyn, NY ruled that the FDA's decision to restrict sale of Plan B to minors was invalid (PDF), because it was politically oriented, ignored scientific expertise, and violated basic principles of federal rulemaking. The court (1) required the agency to reconsider its decision regarding OTC access for women under 17, and (2) ordered that Plan B be made immediately available over the counter for woman 17 and up.

Quick background for non-lawyers: The federal Administrative Procedure Act requires that all federal agency decisions be developed through a good-faith process of reasoned decisionmaking. Rules that are "arbitrary and capricious" can be challenged in court - which is just what a group of parents, teens and reproductive rights groups did. The teens were clearly injured by the decision, the court found, because getting a prescription and going to a pharmacy can make it much harder to obtain Plan B within its 72-hour effectiveness window. As the court rightly noted, "Any delay encountered during this process may render access to Plan B useless." Additionally, the organizations were prevented by the rule from distributing Plan B to minors.

The court held that the FDA's decision was arbitrary and capricious because the agency overrode its own scientific experts on purely political grounds. Here's the court's summary of its findings:
The FDA repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons and, on two occasions, only took action on Plan B to facilitate confirmation of Acting FDA Commissioners, whose confirmation hearings had been held up due to these repeated delays. ...

[Moreover,] the record is clear that the FDA’s course of conduct regarding Plan B departed in significant ways from the agency’s normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use, referred to as a “switch application” or an “over-the-counter switch.” For example, FDA upper management, including the Commissioner, wrested control over the decision-making on Plan B from staff that normally would issue the final decision on an over-the-counter switch application; the FDA’s denial of non-prescription access without age restriction went against the recommendation of a committee of experts it had empanelled to advise it on Plan B; and the Commissioner – at the behest of political actors – decided to deny non-prescription access to women 16 and younger before FDA scientific review staff had completed their reviews.

In light of this evidence, the FDA’s denial of the Citizen Petition [for OTC approval] is vacated and the matter is remanded to the FDA for reconsideration of whether to approve Plan B for over-the counter status without age or point-of-sale restrictions. While the FDA is free, on remand, to exercise its expertise and discretion regarding the proper disposition of the Citizen Petition, no useful purpose would be served by continuing to deprive 17 year olds access to Plan B without a prescription. Indeed, the record shows that FDA officials and staff both agreed that 17 years olds can use Plan B safely without a prescription. The FDA’s justification for this age restriction, that pharmacists would be unable to enforce the prescription requirement if the cutoff were age 17, rather than 18, lacks all credibility.
So, the agency could still decide to restrict sale for some teens, but it will have to base that decision on science, not politics.

(As is often seen on this blog, unjustifiable government decisions beget risible legal arguments. One of the FDA's arguments here was that the minor plaintiffs here lacked standing to sue because they had the support of their parents, and their parents could get Plan B for them without a prescription. The court pointed out the problem with this: under the 2006 rule, a lay person giving Plan B to a minor is illegal. The Government nevertheless argued that this was not a problem because prosecution would be very unlikely - which, the court responded, is hardly the point. You can't justify a law by saying that well, individuals can always break it. Nice try, guys.)

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