Obama Administration to Revise Contraceptives Coverage Accommodation

In response to the SCOTUS decision granting Wheaton College a preliminary injunction against having to comply with the terms of the HHS accommodation available to non-profit religious organizations who object to covering contraceptives for their employees (i.e., submitting a form to their insurance providers), the Obama Administration has announced that it will revise the terms of that accommodation. Instead of requiring objecting employers to provide the form and notice to insurers or third party administrators of self-insured health plans so that they can jump in to provide free coverage directly to employees, HHS will issue new regulations in short order, the details of which remain to be worked out, but will likely allow nonprofit institutions to write a letter stating their objections, rather than filling out the form (see the WSJ story here). This will leave the government to make sure employees are not left without contraceptives coverage.

I may be oversimplifying things, but I think this extended accommodation really isn’t such a big deal.  It seems to just add the government in as a middleman between the objecting employer and the insurer or third party administrator that was responsible for providing coverage under the original accommodation.  In other words, before, nonprofit religious employers with an objection had to fill out the form and give it directly to their insurers; after the modification, those employers could just let the government know, and presumably the government will notify their insurers.  A bit more bureaucracy, but shouldn’t be too big of a problem – probably just a drop in the bucket of the massive ACA bureaucracy, and potentially unnoticeable by the women seeking free contraceptives.  That is unless the employers claim that even this approach leaves them complicit in violation of their religious beliefs.

Since SCOTUS’s substantial burden test as applied in Hobby Lobby focused on the hefty fines for noncompliance, rather than the extent to which the employers’ religious beliefs were directly v. indirectly burdened, the complicity point is an important one to keep an eye on.  Will religious employers be satisfied with simply adding another link to the causal chain?  Perhaps (and I hope).  Technically, all they would be asked to do is announce to the world that they have a religious objection.  What the government does with that information is beyond their control.  If this works out, the revised accommodation could also be extended to the closely held for-profit corporations with religious objections to contraceptives coverage that SCOTUS determined could not be forced to comply with the mandate, such that their employees too could retain access.

So let’s see what HHS can come up with.  Haters gonna hate, as they say, so I’m sure there will be more litigation on this, but hopefully we’re nearing a solution – and I think a good compromise.  The bigger issue will be dealing with all those other services that must be included as essential benefits or preventive services to which religious employers may object, and to which insurers are likely to object to providing free coverage.  But let’s see if the ACA lives to die another day after Halbig and King.

Holly Fernandez Lynch: After Hobby Lobby, ACA Exceptions May Become The Rule

9.25.12StaffHLS0025In a video interview with Reuters in conjunction with Harvard School of Public Heath’s Health Reform Watch, Petrie-Flom Center Executive Director Holly Fernandez Lynch analyzes the impact of the Supreme Court’s recent decisions in Hobby Lobby and Wheaton College.

To watch the interview please click here.

Justice Breyer and Wheaton College v. Burwell

By Gregory Curfman

Tom Goldstein, Publisher of SCOTUSblog, has opined on why Justice Stephen Breyer apparently joined the majority opinion in Wheaton College v. Burwell, which the Court released last Thursday. The majority granted Wheaton a temporary injunction exempting the College from the contraceptive mandate, which was spawned by the Affordable Care Act and which the College claimed violates its religious principles. The vote was 6 to 3, with Justice Scalia filing a concurrence (agreeing “in the result”) and Justices Sotomayor, Ginsburg, and Kagan issuing a forceful dissent. The opinion was unsigned, leaving ambiguous whether Justice Breyer actually did join the majority, though the numbers leave little doubt that he did.

Tom Goldstein believes that Justice Breyer joined the majority because, in doing so, he gained more than he lost. In addition to granting the College an injunction, the majority opinion also states that nothing in the opinion prohibits the government from taking steps to provide women access to contraceptive agents without a copayment. The specific language in the opinion is:

“Nothing in this order precludes the Government from relying on this notice, to the extent it considers it necessary, to facilitate the provision of full contraceptive coverage under the Act.”

Thus, Tom Goldstein believes that in joining the majority, Justice Breyer accomplished the pragmatic objective of preventing the loss of contraceptive coverage for the nation’s women who are employed by nonprofit organizations.

Without comment from Justice Breyer himself, we of course cannot know why he (presumably) joined the majority in Wheaton College v. Burwell, despite the fact he dissented when the Court granted Wheaton College a brief (two-day) injunction earlier in the week. And despite the fact that he also joined Justices Ginsburg, Sotomayor, and Kagan in issuing a very strong dissent in Hobby Lobby v. Burwell. Continue reading

In the Aftermath of Hobby Lobby

By Gregory Curfman and Holly Fernandez Lynch

[A quick follow up to our recent NEJM Perspective on the case, with I. Glenn Cohen]

Immediately after Justice Samuel Alito’s announcement on June 30 of the majority opinion in Burwell v. Hobby Lobby, the Supreme Court took further actions on the contraceptive mandate, and both supporters and opponents of the opinion were furiously assessing the implications and impact of what has proved to be a wild week for women’s access to contraception.

A report from the IMS Institute last April found that 24 million more prescriptions for oral contraceptives without a copayment were written in 2013 (when the contraceptive mandate was in full effect) than in 2012 (when it was not). This translates into a savings of $483 million for women (on average $269 per person). The percentage of women with no out-of-pocket costs for contraceptives increased from 14% to 56%. What will be the impact of the Supreme Court’s decision in Hobby Lobby on these trends?

The Hobby Lobby opinion is quite clear that the contraceptive mandate, spawned by the Affordable Care Act, may not be enforced against closely held, for-profit companies with religious objections to paying for contraceptives coverage. In other words, such companies will not face the hefty fines for noncompliance that would otherwise be imposed by the Department of Health and Human Services.

Nonprofit Organizations

The opinion does not, however, apply to religious-affiliated, nonprofit organizations, such as Catholic schools or religious charities. For such organizations that object to paying for contraceptives coverage, the applicable regulation provided an accommodation by which the entities themselves were off the hook, but instead their insurers (or in the case of self-insured organizations, a third party administrator) would be required to provide free contraceptives coverage without cost to either the employee or the employer.  In order to be eligible for this accommodation, the nonprofit entity must complete a form designating its objection and provide a copy to its health insurance issuer or a third party administrator. A number of nonprofits filed lawsuits asking that they be exempt from even this requirement, on the grounds that they were still being required to violate their religious beliefs by deputizing someone else to provide the objectionable services. One such group, the Little Sisters of the Poor in Colorado, a group of nuns who perform charity work, was granted an injunction by the Supreme Court last January.

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Religious Freedom and Access to Health Care

SCOTUSfrontCheck out the “hot off the press” New England Journal of Medicine Perspectives piece “When Religious Freedom Clashes with Access to Care” by Petrie-Flom Faculty Director I. Glenn Cohen, Executive Director Holly Fernandez Lynch, and NEJM Executive Editor (and PFC Faculty Affiliate), Gregory Curfman.  We review the legal background for SCOTUS’ Hobby Lobby decision, summarize the majority and dissenting opinions, and clarify some key implications of the case, including further problematization of the employer-based health insurance system, reduced likelihood of future attempts to offer religious exemptions to health care mandates, and expanded religious challenges in the health care space.  We close by noting that although the public’s ire and praise has been directed at the Justices, they were applying Congress’ statute – and Congress could (but is very unlikely to) amend the Religious Freedom Restoration Act to be less stringent, or otherwise intervene to ensure that women have affordable access to contraceptive services regardless of their employer’s beliefs.

Take a look and let us know what you think!

On Agency Accommodations and Least Restrictive Alternatives

Nadia N. Sawicki

Did HHS shoot itself in the foot by providing an accommodation to religious non-profits?

In holding that the contraceptive mandate imposed by HHS on Hobby Lobby and Conestoga Wood was not the “least restrictive alternative” for providing no-cost contraceptive coverage to women, the Supreme Court pointed to the accommodation HHS recently provided to religiously-affiliated non-profit corporations. Under the accommodation, “eligible organizations” such as religiously-affiliated hospitals and universities can avoid funding insurance coverage for contraceptives if they certify that they have a religious objection to providing such coverage. In such cases, the eligible organization’s insurance issuer must exclude contraception from the organization’s group health insurance plan, and instead provide a separate issuer-funded contraceptive plan directly to employees. Given that such an accommodation is already in place for some employers, the Supreme Court noted, “HHS itself has demonstrated that it has at its disposal an approach that is less restrictive than requiring employers to fund contraceptive methods that violate their religious beliefs.”

One obvious problem with the Court’s assertion, noted in Justice Ginsburg’s dissent, is that the Court expressly declined to determine whether such an accommodation would in fact be permissible under RFRA. Given the challenges to the accommodation-by-certification requirement already brought by organizations like Little Sisters of the Poor, it is far from clear that the current composition of the Supreme Court would uphold this requirement if faced with a direct challenge.

A second, perhaps less obvious, concern about the Court’s proposal that the eligible employer accommodation be extended to for-profit corporations is that HHS may now regret providing it – and as a result, HHS may refrain from making similar accommodations in the future, which would be a significant loss to defenders of religious freedom.

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Sincerity and Religious Belief in Hobby Lobby

Nadia N. Sawicki

Courts evaluating First Amendment and RFRA claims have long held that they are in no position to evaluate the validity, centrality, or reasonableness of a claimant’s sincere religious beliefs. And while there is room for courts to evaluate whether a claimant’s beliefs are indeed “sincere,” many courts shy away from doing so because of a perceived overlap between judgments about centrality and about sincerity.

In Hobby Lobby, the sincerity of the corporation’s beliefs was not in dispute. Hobby Lobby asserted (and HHS accepted the claim) that it had a sincere religious belief that life begins at conception, and that this belief prohibited it from facilitating access to contraceptives that operate after that point.

But recent news reports have shown that Hobby Lobby has, in fact, been involved in activities that seemingly run afoul of this belief – including investing in pharmaceutical companies that manufacture the contraceptives they raise objections to in their lawsuit, as well as drugs commonly used for abortion; investing in insurance companies that cover abortion and emergency contraceptives; and actually providing coverage for emergency contraception in their own health plan until 2012.

While these facts were not raised before the courts hearing Hobby Lobby’s RFRA claims, First Amendment precedent suggests that they would be relevant to a judgment about the sincerity of Hobby Lobby’s religious beliefs. Surely a company that believes life begins at conception would have more difficulty demonstrating the sincerity of its beliefs when some of its conduct supports activities that are in direct opposition to this stated belief. This is not to say that a court would ultimately conclude that Hobby Lobby’s religious beliefs were insincere – but rather, that a court could legitimately consider these facts without treading into the dangerous territory of judging the merits and centrality of Hobby Lobby’s beliefs to the exercise of its faith.

McCullen and New York Statewide Coalition: The Erosion of Public Health as a Legal Norm

At first glance, last Thursday’s decisions by the Supreme Court in McCullen v. Coakley and the New York Court of Appeals in New York Statewide Coalition of Hispanic Chambers of Commerce v. New York City Department of Health and Mental Hygiene, have little in common. McCullen, which struck down a Massachusetts law establishing a 35 foot buffer zone around reproductive health clinics, was a First Amendment case that dealt with the always contentious issue of abortion. In contrast, N.Y. Statewide Coalition, which upheld a lower court decision striking down a regulation of the New York City Board of Health barring the sale of large portions of sugary soda, was decided on state administrative law grounds, with the court finding that the Board exceeded its authority.

On closer inspection, however, the two cases share several features in addition to their date of decision. One is the failure to give substantial weight to the state’s interest in protection health. In his opinion for the Court in McCullen, Chief Justice Roberts accepted that the buffer zone law was content neutral and therefore not subject to strict scrutiny. Nevertheless, a unanimous Court held that the Massachusetts law was not narrowly tailored to serve the government interests of protecting public safety and access to health care. In reaching this decision, the Court focused on the “toll” that the buffer zone placed on the abortion opponents who tried to dissuade woman from having abortion, rather than the impact of the lack of such a zone on woman seeking reproductive health care. Equally important, the Court showed no willingness to defer to the state’s contentions that alternative regulatory approaches had proved unsatisfactory. Rather the Court insisted that given “the vital First Amendment interests at stake, it is not enough for Massachusetts simply to say that other approaches have not worked.”

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The U.S. Supreme Court vs. the American Psychological Association

by Dov Fox

The U.S. Supreme Court has not in recent years held the views of the American Psychological Association (APA) in so high regard as it did this week.

In 2012, the Court set aside the APA’s arguments for why due process requires the exclusion of eyewitness testimony obtained under suggestive circumstances that rendered it especially likely to be unreliable.

And in 2011, when the Court struck down on free speech grounds a state regulation on violent video games, it gave short shrift to the APA’s warnings about those games’ connection to violent behavior in young boys.

But in its recent death penalty decision, Florida v. Hall, the Court relied heavily on important APA insights in declaring it unconstitutional for states to set an IQ cutoff to determine whether a prisoner is eligible to receive capital punishment. Continue reading

CONFERENCE – CLASHING RIGHTS & REPRODUCTIVE AUTONOMY

Join us at Northeastern University School of Law at 1 p.m. on April 25, 2014 as leading academics and practitioners discuss the tensions between free speech and reproductive rights.

For more information, see http://www.northeastern.edu/law/academics/institutes/health-law/events/clashing-rights/

Smoke and Mirrors and Women, Oh My

[Guest post by Katherine L. Record, JD, MPH, MA]

Last week the Supreme Court attracted lots of attention when it heard arguments about whether a corporation can exclude mandatory preventive benefits from its employee health plan, based on a religious objection to certain types of healthcare.  This is a tale as old as time; religion has long been the basis for opposition to reproductive (i.e., women’s) health – including the preventive healthcare now in question, contraception.

Yet this argument has nothing to do with government infringement on the practice of religion.

In fact, the corporation, Hobby Lobby, covered two of the four contraceptive devices in dispute until its lawyers were actually arguing the issue in court, apparently to little detriment to the company’s faith in God.  What’s more, Hobby Lobby’s 401(k) includes more than $73 million invested in the companies that produce these objectionable contraceptives (e.g., intrauterine devices, emergency contraception).

This has not stopped Hobby Lobby from arguing that the Affordable Care Act (ACA) is threatening its freedom, as a corporation, to practice religion.

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A new framework for considering the contraceptives mandate cases?

Just a quick pointer to an interesting new article out by Kara Loewentheil at Yale, When Free Exercise Is a Burden: Protecting ‘Third Parties’ in Religious Accommodation Law.  

Here’s her abstract (posted a few weeks ago before cert was granted):

As of November 2013, over 60 lawsuits have been filed under the First Amendment and the Religious Freedom Restoration Act (“RFRA”), challenging the contraceptive coverage requirement (“CCR”) of The Patient Protection and Affordable Care Act, more than half brought by for-profit employers with religious objections to providing insurance coverage for contraception. The conflict combines questions of the reach of the regulatory state, the nature and purpose of free exercise rights, women’s social and economic equality, and a lightning-rod political debate. No wonder then that these cases have produced a circuit split, and are now primed for a Supreme Court ruling, as two cert petitions in these cases were filed in September 2013. It is no surprise that these cases have produced such divergent results, because the problem lies not with the courts, but with the doctrine, which frames the conflict as being between the State and the religious objector. But as the CCR cases make clear, this relationship is often beside the point entirely. Rather, some religious accommodation cases regulate not only the relationship between the State and the objector, but a variety of conflicts and relationships between the religious objectors and various other rights-holders. The courts and the scholarship have occasionally noticed that such conflicts may exist but have not suggested any systematic way of thinking about or resolving them. To remedy this lacuna, I propose a framework for identifying and analyzing these under-theorized conflicts, elaborating on strands of concern for third parties in the doctrine that have never been fully fleshed out. I argue that once we identify the set of cases in which there are sufficiently weighty third-party interests at stake – whether practical or expressive – to merit deviation from the standard doctrinal framework, the question should be whether the State can provide a solution that respects all the rights in question. If so, it should have an obligation to do so. If not, the group with equality-implicating rights (again, whether practical or expressive) should “win” – with any “tie” going to the third parties, because the purpose of religious accommodation law is to protect the equality of religious objectors, not to privilege religion. The CCR suits present a paradigmatic example in which the State’s most important interest lies in its representation of the rights of third parties, and in which comprehensive solutions respecting all parties’ rights are possible but not doctrinally required, thus providing a clear illustration of why the framework I suggest would be an improvement in religious accommodation law. Nevertheless, there are also ways to better balance the interests involved through use of the existing doctrine, as the last part of this paper demonstrates.

A “Torrent of Studies” on Direct-to-Consumer Advertising: Is FDA Shoring Up Its Defenses?

By Kate Greenwood

Cross-Posted at Health Reform Watch

At Regulatory Focus earlier this week, Alexander Gaffney wrote about what he characterized as “a torrent of studies” that FDA is conducting or has proposed conducting on prescription drug promotion, and, in particular, on direct-to-consumer advertisements.  The studies include, among others, a survey study aimed at sussing out “the influence of DTC advertising in the examination room and on the relationships between healthcare professionals and patients”, a study exploring similarities and differences in the responses of adolescents and their parents to web-based prescription drug advertising, and a study that will use eye tracking technology to collect data on the effect of distracting audio and visuals on participants’ attention to risk information. 

Gaffney speculates that “the proposed studies could indicate coming changes in FDA’s regulatory approach toward advertising[.]”  Another possibility is that the studies are part of an effort by FDA to build up the evidence base supporting its current regulatory approach.  In a Tweet commenting on Gaffney’s article, Patricia Zettler–a  Fellow at Stanford Law School’s Center for Law and the Biosciences who was formerly an Associate Chief Counsel for Drugs at FDA’s Office of Chief Counsel–asks whether the data generated by the studies could help insulate FDA from First Amendment challenges. Continue reading

Unreliable Biomedical Science, and a Solution?

The Economist has a long, detailed, and readable piece about the difficulties of inferring anything from the published findings of biomedical science.  There are all sorts of problems that fall short of scientific fraud, including the the biases caused by industry-funding of biomedical science, the biases of unblinded raters who see what they want to see, and the biases of journal editors towards only publishing “positive” findings.  (I am particularly enamored with this graphic, which shows the fundamental problem of inference.)  It is rare for researchers to even bother to attempt to replicate prior findings, but when replications are attempted, they often fail.  

The Economist piece can be read as something close to an outright assault on empiricism, at least as we now know it.  In practical terms, it is prudent for physicians, patients, and payors to be wary of the findings presented in even the top journals.

One of the beauties of our scientific system is that it is wildly decentralized.  Scientists (and their funders) can test any hypothesis that they find interesting, and they can use whatever methods they prefer.  Likewise, journal editors can publish whatever they want.  While such academic and market freedom is attractive, it results in quite a hodgepodge of science, with replication studies and publication of null results being afterthoughts.  The NIH and NSF have in the past functioned to set an agenda and demand rigor, but as their funding wanes, the chaos waxes.

The problems are scientific, but any solution will be institutional (and thus legal).  I have argued for a partial solution to industry bias in my short article, called “The Money Blind:  How to Stop Industry Influence in Biomedical Science Without Violating the First Amendment.”  Independent scientific testing could be conducted by a neutral intermediary, which would pool funds.  In a similar vein, there is also a new project of the Science Exchange, called “The Reproducibility Initiative.”  This program offers to be the independent scientific agency, which attempts to validate known results.   But there is not yet a large-scale funding model in place.  If biomedical journal editors would at least put disclosures in their structured abstracts (an intervention we have tested), over the long run that may also nudge industry to use such gold-standard independent testing, when they have something that is truly provable.  And, at least in the domain of the products regulated by the FDA, the agency should consider using its current statutory authority to push companies towards independent, robust, and replicated science.

Handling Debate by Threatening Legal Action: Anti-Vaccination Activists in Israel

Dorit Reiss has a new op-ed in The Times of Israel describing defamation suits that are being brought in the midst of the vaccination debate. Take a look.

Anti-vaccination activists in Israel have recently resorted to threatening critics with defamation suits over comments in online social-media discussions. This is not a new tactic: In several countries, anti-vaccination activists have brought lawsuits against critics, with very little success in actually winning cases but with a potential chilling effect on the discussion. Such a tactic is inappropriate – both because of its effect on the market of ideas and because the anti-vaccination activists themselves regularly engage in personal attacks on critics. Israeli Courts or disciplinary boards should not support or allow this attempt to silence vaccine advocates, and Israeli citizens and supporters of Israel deserve to know this tactic is used.

Read more …

“When Truth Cannot Be Presumed” Burning Up SSRN

Make sure to check out “When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under an Expanding First Amendment,” by our very own blogger – and former Petrie-Flom Center Academic Fellow – Christopher Robertson.  Chris presented this paper at our annual conference last year, blogged about it here, and must really be on to something, as his paper has already been downloaded from SSRN more than 1,100 times in the past 10 days.  Take a look for yourself.

Intent, Legal Metaphysics, and the Regulation of Stuff

I recently posted my new article “When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under an Expanding First Amendment“.  The article is forthcoming next year in Boston U. Law Review, but I have plenty of time to make revisions.  So I would love to get the feedback from BillofHealth readers.

Hamlin's Wizard Oil

One of the preliminary themes of the article is that the  Food, Drug, and Cosmetic Act is predicated on the drugmaker’s own intent that a substance be used to treat a disease.  The exact same chemical compound can be  sold for other purposes without any FDA oversight.  But once the drugmaker intends that the substance be used as a drug, it becomes a drug as a matter of law, and then each intended use must be proven as safe and effective to the FDA.  For example, turpentine has had this dual-life as a paint-thinner and as “Hamlin’s Wizard Oil,” for which “there is no sore it will not heal, no pain it will not subdue.”

This intent-based system of regulation sets up a confrontation with the First Amendment, since the drugmaker’s own speech is often the best evidence of its intent.  It is a pretty big confrontation too, since the intent concept is the very predicate for the entire FDA regulatory regime.  On the other hand, it is hard to conceive of an alternative threshold for what counts as a drug.  There was a time (e.g., the 1993 Mitchell case) when a ConLaw scholar could confidently say that such evidentiary use of speech presents no First Amendment problems at all, but the current Supreme Court has been eager to dispense with such formalisms (c.f., the 2012 Alvarez case).

In my research on this point, I found a few other intent-based regulations that metaphysically transform things into the objects of a regulatory regime.  For example, the distinction between whether the Federal Aviation Administration regulates your family station wagon depends on whether the carmaker intends it to fly.  (See note 20 of the paper.)  Perhaps a broader analysis is in order.  If the First Amendment undermines this mechanism of regulation, what other similar regulatory regimes may be threatened?

There’s an App for This: The Constitution

[Guest post from the Library of Congress]

Direct Access to Expert Analysis of the Supreme Law of the Land   

The Senate Committee on Rules and Administration, the Library of Congress, and the Government Printing Office (GPO) mark Constitution Day today by launching a new app and web publication that make analysis and interpretation of constitutional case law by Library experts accessible for free to anyone with a computer or mobile device.

The new resources, which include analysis of Supreme Court cases through June 26, 2013, will be updated multiple times each year as new court decisions are issued. Legal professionals, teachers, students, and anyone researching the constitutional implications of a particular topic can easily locate constitutional amendments, federal and state laws that were held unconstitutional, and tables of recent cases with corresponding topics and constitutional implications.

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The First Amendment Meets Public Health Again — The US AID Case

Sometimes it seems as if the First Amendment is the leading legal threat to public health. Not today. In Agency for International Development v. Alliance for Open Society International the Supreme Court in a 6-2 decision struck down on First Amendment ground the so-called “anti-prostitution pledge” imposed by § 7631(f) of the  Leadership Act which prohibited the award of anti-HIV grants to groups or organizations that do “not have a policy explicitly opposing prostitution and sex trafficking” constituted an unconstitutional condition. Critical to the Chief Justice Roberts’ opinion was the fact that § 7631(f) did not simply limit grantees’ ability to use federal funds to support prostitution. Rather, it compelled a “grant recipient to adopt a particular belief as a condition of funding.”  According to the Court, the government can limit what grantees do with federal funds, but it cannot restrict what they believe.

Although the Court ‘s opinion focused on core First Amendment issues, rather than the public health impact of the anti-prostitution pledge, its decision should remind us of the complex and sometimes ambivalent relationship between public health and the First Amendment. Since the early years of the HIV epidemic, the First Amendment has been a crucial public health ally, limiting government’s ability to censor controversial but critical public health information. In many other cases, however, such as those challenging regulations aimed at tobacco or pharmaceutical advertising, a robust interpretation of the First Amendment seems to hinder public health protection. For public health law advocates, a key question is whether the First Amendment can be interpreted so as to protect health in both sets of circumstances. Equally critical is understanding how we can achieve public health goals without relying on the regulation of speech. Alliance for Open Society may offer some clues, but it clearly does not provide the answers.