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.)

Protecting our children

Via Feministe: despite promises from Democrats, the proposed Omnibus Appropriations Act retains most funding for ineffective abstinence-only education. Click here to tell Congress to stop funding this nonsense.

Meanwhile: Waking Vixen asks why, when minors involved in prostitution are apparently being treated more leniently than adults, minors who produce their own amateur pornography are treated more hashly than adults. It seems the same concerns would apply to both situations involving possible coercion, later effects of the fact of involvement on the minor's life, and the possibility of feeding a market that promotes abuse of minors generally are applicable in both contexts.

WV's post is prompted bythe FBI's recent arrests in various cities of a large number of adult sex workers and their clients, which is being touted by the FBI as part of a campaign against child prostitution.

USCIS: Gardasil mandate not our decision

Today's Los Angeles Times suggests that not only was it not the decision of Citizenship and Immigration Services to mandate the HPV vaccine for all immigrant women 11-26, but they can't do anything about it:

A 1996 immigration law directs the Citizenship and Immigration Services to require that new immigrants receive inoculations that the CDC's immunization committee recommends for U.S. residents.

"It's not really a decision of ours," said immigration service spokeswoman Sharon Rummery. "We can't cherry-pick the recommendations."

In other words, it appears the culprit in this instance is not CIS, but a too-rigid requirement in the Illegal Immigration Reform and Personal Responsibility Act of 1996. That requirement might have made sense on paper, but it doesn't take account of the possibility that the CDC will recommend immunizations in a case where the public health threat doesn't justify a mandate for anyone. In fact, the CDC itself recognizes the problem, and says it simply hadn't thought about the 1996 law:

"If we had known about it, we would have said it's not a good idea," said Jon Abramson, who was chairman of the CDC's Advisory Committee for Immunization Practices when the body recommended the vaccine for U.S. citizens last year.

Looks like the solution is a common-sense modification to this federal statute - another item, hopefully, to add the very large agenda of Congressional Democrats next year.

EEOC opposes HHS "provider conscience" rule

The Equal Employment Opportunity Commission has joined the chorus of criticism of the Department of Health & Human Services's proposed "Provider Conscience" rule, which many are concerned could limit access to contraception:

In its comment, EEOC says Title VII of the 1964 Civil Rights Act ensures a constitutionally sound right to the accommodation of religious practices "for all employees, including health care employees." The proposed rule, purporting to create "an absolute right to religious accommodation," detracts from the employer’s ability to show "undue hardship" and throws off the balance of Title VII analysis, it says.

Unsurprisingly, HHS says it has received a "higher than usual" number of comments on this proposal, for which the comment period just ended.

Via Workplace Profs Blog.

Quick hit: US to require Gardasil for immigrants

As Jill at Feministe said:

I am all for making Gardasil more accessible and affordable. I think there’s a good argument to be made for making it a mandatory vaccine for school-age children — with an easy voluntary opt-out clause — because in many states that’s the only way that low-income families will be able to afford it, since mandatory vaccines are more likely to be covered by Medicaid (I also think there’s a better argument against it, but that’s another post). I think there’s a very good (and obviously widely-accepted) common-sense argument to be made for making certain vaccines mandatory for new immigrants or visitors to the U.S. — and some vaccines for highly communicable and airborne diseases are mandatory. That’s reasonable.

But making the HPV vaccine a requirement? It’s both unnecessary and frightening. It’s also shamelessly xenophobic.

Indeed it is - foreigners as sexual threat, anyone? Ick.

There has been a lot of press about adverse reactions, but thus far I think it has been overblown. Given the public concerns and some degree of real uncertainty, it's appropriate right now to back off of plans to mandate Gardasil for U.S. schoolchildren. If and when these fears die down, mandating the vaccine for schoolchildren will make good sense. For now, promoting voluntary vaccination still makes sense to me, though we should remember that (as was recently said at RH Reality Check) there's more to HPV prevention than Gardasil.

But making it a condition for immigration, without covering the cost, is just another unfair barrier. Vaccination is a good thing, but HPV does not pose anything like the kind of epidemiological threat that would justify requiring it in this circumstance. Moreover, the considerable ($300+) cost of Gardasil will no doubt be (yet) a(nother) barrier for some individuals and families.

California Supremes: No religious exception to civil rights in medicine

The California Supreme Court said today:

Do the rights of religious freedom and free speech, as guaranteed in both the federal and the California Constitutions, exempt a medical clinic’s physicians from complying with the California Unruh Civil Rights Act’s prohibition against discrimination based on a person’s sexual orientation? Our answer is no.

The unanimous decision, ten years in the making, came in Benitez v. North Coast Women's Care Medical Group (PDF). Lupita Benitez was stalled, given unnecessary treatments, and finally turned away when North Coast made clear it would not provide artificial insemination to a lesbian. Benitez ultimately got the services elsewhere and is now a mother of three, but fought to the state's highest court to make sure that facilities like North Coast can't use religious beliefs as an excuse to discriminate in the provision of health care.

Background on religious exemptions

North Coast's religious freedom defense won't be going before the U.S. Supreme Court: the Court has interpreted the federal constitution as not requiring religious exemptions from "neutral laws of general applicability." Employment Division v. Smith (1990). Nevertheless, state constitutions may and often do provide more robust protections for individual rights than does the federal constitution, so religious objectors have continued to argue for religious exemptions from various laws in the state courts. The California Supreme Court rejected such an argument in 2004 in the Catholic Charities case (PDF), which involved the California Women’s Contraception Equity Act. There, the court declined to set out a specific test for religious exemption claims, concluding that under even a strict standard -- i.e., the most protective for religious objectors - there wouldn't be an exception for Catholic Charities.

Reasoning of the decision

The court draws the same conclusion today in Benitez. Specifically, it says that the state's antidiscrimination law furthers a compelling state interest in social equality, and there is no way for the state to advance that interest without some burden on the religious exercise of medical providers. The court notes, however, that if North Coast specifically objects to providing artificial insemination to lesbians, it stay true to its religious beliefs by choosing not to offer that service to anyone.

North Coast made the intriguing argument that the text of the California constitution mandates an unprecedented, almost total protection for religious objectors to state laws. The constitution says religious liberty is "guaranteed," but "does not excuse acts that are licentious or inconsistent with the peace or safety of the State." North Coast therefore argued that combating "licentiousness" or protecting "the peace and safety of the State" are the only permissible grounds for laws that do not allow religious exemptions. The court rejected this approach. Concluding, the court made clear that North Coast can seek to prove that it denied services to Benitez on some other ground, but can't simply claim liberty of conscience.

Impact of the decision

As was much discussed after Marriage Cases, the California Supreme Court is the most-cited state supreme court in the nation. The decision in Benitez is likely to be followed in other states' courts. The decision's implications go far beyond the field of infertility care or even health care more generally: it means that there is no general religious-belief exception to the civil rights laws in the provision of commercial services and public accommodations.

This decision is correct. There are, of course, areas antidiscrimination laws can't reach because of the right to privacy and the freedom of association. But so far as they go, these laws should not be subject to a carve-out for those who claim a religious obligation to discriminate.

Is "safe sex" speech protected at "abstinence-only" schools?

Two Illinois high school students were recently suspended from school for wearing shirts reading "Safe Sex or No Sex," and decorated with condoms. They were dissatisfied with their school's "abstinence-only" approach to sex education. The girls are to be commended for speaking up. (I'm reminded, fondly, of my own first adolescent gropings toward political activism.)

One immediately wonders, of course, whether the girls have a viable First Amendment claim. The lesson of Morse v. Frederick, it seems, is that schools can punish student speech if it promotes activity the school is legitimately trying to discourage. The school would argue that the t-shirts were promoting teen sex, contrary to the school's abstinence curriculum, and that this is analogous to a message promoting drug use. The decision in Frederick was narrowly framed, however, and the Court disclaimed any application to "political speech."

Is "Safe Sex or No Sex" political speech? It seems to me that there are two messages here: (1) advocating that those who choose to have sex use protection, and (2) protesting the school's curriculum. The latter is clearly political speech. The former is arguably political as well, since it a message of significant social important, and "political speech" has always been broadly construed. It seems to me disingenuous to say that the shirts promoted teens having sex per se, but of course whether promoting safe sex is promoting sex is, in a way, the crux of the debate over traditional vs. abstinence-only sex ed. Moreover, unlike Frederick, there is no indication that criminal activity is being advocated, since most teen sex is perfectly legal (although, most would say, contrary to public policy).

While this story may never become a lawsuit, many teens across the nation have similar sentiments, and this particular controversy is likely to be replicated, and sooner or later, litigated.

HPV vaccination: the litigation begins

Reportedly thirty-three states have now begun considering bills to promote or require the revolutionary HPV vaccine (here's a summary of six of those). While cultural-conservative response during the FDA approval process was relatively muted (as compared to the long struggle over OTC emergency contraception), there is now a full-blown debate about whether the vaccine should be mandated, largely arising from HPV's status as a sexually transmitted disease.

Inevitably, the litigation has begun, with several Texas parents challenging Texas Gov. Rick Perry's executive order mandating the vaccine for sixth-grade enrollment. While the claim in this case appears to one in state law alleging that the Governor exceeded his authority, this will not be the only such suit, and others will surely raised constitutional objections. These claims, I expect, will be based either on the right to bodily integrity or the right to direct the upbringing of one's children. Free exercise claims are also imaginable, although the mandatory vaccination bills out there seem generally to include religious exemptions.

The natural question becomes the application of Jacobson v. Commonwealth, in which the Supreme Court in 1905 rejected a constitutional challenge to mandatory smallpox vaccination. The Court there held that (1) individual liberty interests could in appropriate circumstances be overridden by public health measures, and (2) the legislature having judged a mandatory scheme proper in accordance with overwhelming medical opinion, it was not for the courts to undertake a fresh examination of claims about the safety or efficacy of the vaccine. That case is still good law, as demonstrated by the Court's need to distinguish it in the Cruzan case, and by a military appeals court's recent reliance on it to uphold a mandatory anthrax vaccination. U.S. v. Schwartz, 61 M.J. 567 (N.M. Ct. Crim. App. 2005).

Of course, one vaccination is not the same as another; the public health implications of cervical cancer and smallpox are also quite different. Nearly 12,000 diagnoses and 4,000 deaths per year is a serious problem, but it is not highly contagious and does not rise to the level of a public emergency.

On the other hand, the potential parental objections seem relatively slight. Rather than asserting that the HPV vaccine is dangerous (as in Jacobson), parents would presumably be asserting simply that its safety and efficacy are uncertain, and/or that it would interfere with their parental prerogative in teaching proper sexual values. As in Jacobson, medical authority overwhelmingly supports the safety and efficacy of the vaccine. The risk of physical harm is merely speculative, as is the "risk" that vaccination would encourage adolescent sex. In any event, vaccination in no way prevents parents from teaching their children - and if they want to teach them to fear sex, there are plenty of other risks to spook them with.

Nevertheless, I would expect to see some ingenious arguments being made against mandatory vaccination, in both the legislatures and the courts, as this issue plays out across the country.

Edit: As the commenter below rightly indicates, the forthcoming legislation will likely have generous opt-out provisions, thus largely vitiating any constitutional objections by parents. In the context of school prayer, the Supreme Court has said that opt-outs are not enough to protect the objector because the opting-out child may be ridiculed by others. No such concerns apply here, and even if they did they only really have force in the Establishment Clause context. I shouldn't be surprised, however, if some creative arguments are put out there to challenge vaccination nonetheless -- so much is suggested by the current political debate, despite the opt-outs.