A Federal District Court Judge in New York has issued an order overturning a rule promulgated by the Food And Drug Administration mandating that girls under 17 can only receive “Plan B” and other similar “Morning After” contraceptives via prescription and ordered the FDA to allow women of any age to receive such medication over the counter:
A federal judge ruled Friday that the government must make the most common morning-after pill available over the counter for all ages, instead of requiring a prescription for girls 16 and younger. In his ruling, he also accused the federal government of “bad faith” in dealing with the requests to make the pill universally available, and said its actions had been politically motivated.
The decision, on a fraught and politically controversial subject, comes after a decade-long fight over who should have access to the pill and under what circumstances. And it counteracts an unprecedented move by the Obama administration’s Health and Human Services secretary, Kathleen Sebelius, who in 2011 overruled a recommendation by the Food and Drug Administration to make the pill available for all ages without a prescription.
In a decision in a lawsuit filed by advocates, the judge, Edward R. Korman of Federal District Court, ruled that the government’s refusal to lift restrictions on access to the pill was “arbitrary, capricious, and unreasonable.”Judge Korman ordered the F.D.A. to lift any age and sale restrictions on the pill, Plan B One-Step, and its generic versions, within 30 days.
“More than 12 years have passed since the citizen petition was filed and 8 years since this lawsuit commenced,” the judge wrote. “The F.D.A. has engaged in intolerable delays in processing the petition. Indeed, it could accurately be described as an administrative agency filibuster.”
He added, “The plaintiffs should not be forced to endure, nor should the agency’s misconduct be rewarded by, an exercise that permits the F.D.A. to engage in further delay and obstruction.”(…)
Scientists, including those at the F.D.A., have been recommending unrestricted access for years, as have major medical groups, including the American Medical Association, the American Congress of Obstetricians and Gynecologists and the American Academy of Pediatrics. They contend that the restrictions effectively keep many adolescents and younger teenagers from being able to use a safe drug in a timely way to prevent pregnancy, which carries greater safety risks than the morning-after pill.
In 2011, the F.D.A. commissioner, Dr. Margaret A. Hamburg, issued a statement saying that after rigorous study, it was safe to sell Plan B One-Step over the counter for all ages. But she was overruled by Ms. Sebelius, the Health and Human Services secretary, the first time such a public countermanding had ever occurred.
In her decision, Ms. Sebelius said that Plan B’s manufacturer had failed to study whether the drug was safe for girls as young as 11, about 10 percent of whom are physically able to bear children. But her decision was widely interpreted in a political context because emergency contraception has become an issue in the abortion debate and because allowing freer access to adolescents would prompt critics to accuse the Obama administration of supporting sexual activity for girls of that age. At the time, President Obama supported Ms. Sebelius’s decision, saying, “I will say this, as the father of two daughters: I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine.”
I’ve seen a lot of discussion online already about this decision, much of it quite obviously not from people who either have not read the decision or don’t really understand the law that’s involved here. Essentially, this case involves a review of rulemaking by a regulatory branch by a Federal Court pursuant to the Administrative Procedure Act, a law passed in 1946 to establish a standard for judicial review of the myriad of rules being drafted by the regulatory agencies that came into being during the New Deal and World War II. Under the law, a Federal Court must uphold a rule adopted by a Federal agency unless there is a finding, made after a hearing on the merits, that the rule is “”arbitrary and capricious, an abuse of discretion, or otherwise not in accordance with the law.”
In the case we’re dealing with here, the question is whether or not the FDA decision to limit over-the-counter availability of Plan B and related drugs to women over 17 had a rational scientific basis, or whether it was based on something other than the scientific criteria that the FDA is required by statute to consider when it’s making a decision like this. In other words, this case was not about whether or not it is a good idea as a matter of public policy to allow minors to have access to Plan B and other “morning after” drugs, but about whether a rule from the FDA that barred such access could be justified under the rulemaking authority granted to the agency. The judge’s opinion, which I’ve embedded below, goes through a rather detailed examination of both the applicable law and the scientific evidence that was presented to the Court, but it’s really the opinion’s closing paragraphs that sum up the Judge’s decision:
The decisions of the Secretary with respect to Plan B One-Step and that of the FDA with respect to the Citizen Petition, which it had no choice but to deny, were arbitrary, capricious, and unreasonable. I decline to direct a remedy comparable to that which I directed in my 2009 opinion, such as directing that emergency contraception be made available without a prescription but with the current point-of-sale restrictions to women whom studies have demonstrated are capable of understanding the label and using the product appropriately. As I have previously observed, the obstructions in the path of those adolescents in obtaining levonorgestrel-based emergency contraceptives under the current behind-the-counter regime have the practical effect of making the contraceptives unavailable without a doctor’s prescription. Consequently, the decision of the FDA denying the Citizen Petition is reversed, and the case is remanded to the FDA with the instruction to grant the Citizen Petition and make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within thirty days. On remand, the FDA may determine whether any new labeling is reasonably necessary. Moreover, if the FDA actually believes there is any significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one-pill product.
(…)
[E]ven if the defendants’ arguments would be sufficient to carry the day in the runof-the-mill case, 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. More than twelve years have passed since the Citizen Petition was filed and eight years since this lawsuit commenced. The FDA has engaged in intolerable delays in processing the petition. Indeed, it could accurately be described as an administrative agency filibuster. Moreover, one of the devices the FDA has employed to stall proceedings was to seek public comment on whether or not it needed to engage in rulemaking in order to adopt an age-restricted marketing regime. After eating up eleven months, 47,000 public comments, and hundreds of thousands, if not millions, of dollars, it decided that it did not need rulemaking after all. The plaintiffs should not be forced to endure, nor should the agency’s misconduct be rewarded by, an exercise that permits the FDA to engage in further delay and obstruction.
It was in the end a rather scathing vilification of the FDA’s actions in this matter and, reading through the opinion, one gets the clear impression that the Judge came to the conclusion that the decision by HHS Secretary Sebelius to issue the order limiting over-the-counter sales to women over 17 was motivated more by politics than by the scientific standards that the FDA and the HHS is supposed to be governed by, especially given the fact that this is an issue that has been pending for twelve years, including four years during which the Obama Administration has been in control of the relevant agencies.
I don’t consider myself enough of an expert in either the science of this matter or Federal Regulatory Law to be able to say whether Judge Edward Herman, who was appointed to the Eastern District of New York by President Reagan way back in 1985, got this matter correct. It also seems quite apparent that this decision will be appealed to the 2nd Circuit Court of Appeals, and that Judge Herman’s decision will be stayed while this appeal is pending. So, this is far from the final say on this matter. That said, to the extent that Judge Herman’s decision is based upon the factual findings he made during the course of this matter, it’s going to be very difficult to overturn the decision on appeal unless the appellate court in question finds that the court was manifestly wrong in its factual conclusions. This may make it difficult for an appellate court to overturn the decision.
Of course, most people who hear about this decision won’t be thinking about the discrete legal matters at issue in this case. They’ll be thinking about the policy question of whether minors should be able to have access to these types of medication without a prescription and, potentially, without parental knowledge and consent. As I noted above, that is a policy issue that was not within the purview of the FDA to begin with. Indeed, even if this ruling stands, it would still be within the authority of Congress to reverse the ruling via legislation that says that minors must have a prescription before obtaining the “morning after” pill. Personally, as I’ve said before, I think all contraceptives, including “morning after” pills should be available over-the-counter, but I do have some doubts about how much that policy ought to apply to minors, especially if we’re talking about girls as young as 13 or 14 years old. I’ll admit I don’t have a scientific basis for these doubts, it’s really more of a visceral reaction and a reflection of how I’d feel if we were talking about a child of mine. I’m not sure, though, that those doubts, or the fears of many on the right that their children may be more sexually active than they’d like to pretend that they are, ought to be the basis for public policy.
Here’s the opinion:
