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.

Live Blogging from FDA in the 21st Century Conference, Plenary 2: Alta Charo on Integrating Speed and Safety

[This is off-the-cuff live blogging, so apologies for any errors, typos, etc]

Day two of PFC’s FDA in the 21st Century conference begins with a morning plenary by the very fabulous Alta Charo, of the University of Wisconsin Law School, who is speaking on “Integrating Speed and Safety.”

Today Alta is presenting what she calls “more of an initial idea than an actual proposal,” and she notes that she’s very interested to hear responses to it, so comment away or contact her offline. She wants to integrate into the usual and longstanding “FDA speed versus safety” debate some concerns that should be of interest to industry. “In other words,” she said, “I’d like to be nice to the drug people.”

Alta begins with a brief history of the speed versus safety debate, which turns out to be quite cyclical. Before 1906, she asks us to recall, we had true snake oil: products with high toxicity and little or no efficacy. Often these products were nevertheless perceived as effective because they contained alcohol or other drugs, so made you feel better at least, but of course that’s part of what made these products so dangerous, especially for children.

And so with the Federal Food and Drugs Act of 1906, we get post-market remedies for misbranding, although they require proof of intent. And then in 1937 over 100 children die from elixir of sulfanilamide. And the following year we get the Food, Drug, and Cosmetic Act. But the FDCA targets only safety. (Although rightly Alta notes that it’s hard to see how regulators were truly only looking at safety and not also at some form of efficacy, since there is no such thing as safety in the abstract, only safety relative to purpose for which someone is taking the drug.) Continue reading

Live Blogging from FDA in the 21st Century Conference, Panel 3: Protecting the Public within Constitutional Limits

[Posted on behalf of W. Nicholson Price IIAcademic Fellow, The Petrie-Flom Center (with the disclaimer re: live blogging - see posts below)]

The third panel at the conference covered commercial speech protection and off-label drug promotion, in reaction to the Second Circuit’s December 12 case, United States v. Caronia.  Caronia was promoting Xyrem, approved for narcolepsy, for off-label uses, which is prohibited by FDA.  He was criminally charged and convicted, but the Second Circuit held this prohibition constitutionally suspect.

Leading off was Aaron Kesselheim.  Aaron started off describing the FDA’s prohibition on off-label promotion.  Off-label promotion prohibition is based on the requirement of substantial evidence for efficacy.  There are some safe-harbors, like distributing papers, but generally off-label promotion is prohibited because promotion drives prescription patterns, and off-label promotion for unapproved uses can have significant negative consequences.  FDA has negotiated many major settlements, totaling billions of dollars in recent years.  In this context, the Caronia decision is troubling from a public health point of view, even if not particularly surprising given the history of commercial free speech doctrine.

Aaron described four ways forward for the FDA after Caronia.  First, the government could rely more heavily on written materials as evidence, arguing that it is part of the label.  Second, the government could change the prosecutorial language, using speech as evidence of an attempt to misbrand, rather than prosecuting for speech; this might not be enough to fix the problem.  Third, the government could prosecute off-label promotion as false and misleading speech, but that requires hard case-by-case evaluations.  Fourth, the government could better argue that the Central Hudson test for commercial free speech is met.

Next, Chris Robertson also took Caronia as a jumping-off point, noting that Caronia was actually convicted of conspiracy to introduce a misbranded drug into interstate commerce – though the Second Circuit held he was actually convicted for his speech.  Caronia comes in the wake of robust First Amendment jurisprudence from the Supreme Court, including Citizens United, Sorrell, Stevens, Alvarez, and Fox v. FCC, and thus might be a harbinger of this reasoning spreading across the country.  In addition, the reasoning of Caronia could potentially apply equally to drugs with no approved use, and thus undermine the entire FDCA (since what is defined as a drug is determined by label claims).

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A Tale of Two Polities

By Scott Burris

Last week, Northeastern University’s effort to convene a much-needed conference on the future of health policy was a casualty of the successful manhunt for the Boston Marathon bombers.  One hardly wants to make too much of a stymied conference given all the human damage of the bombing and its aftermath, but all of us who had gathered for the meeting regretted that we would not hear from the panelists, and sympathized with organizers who had put so much into planning it.  In recognition of that, I am summarizing here what I planned to say there.  It is a tale of two polities that seem to compete for existence in our perceptions of the politics of public health.

One public health is incredibly popular with citizens and lawmakers alike – demonstrated by polling and passage of legislation.  I’ve recently blogged on this here.  The other public health is the despised nanny state, big government, the sequestered and slashed-to-the bone struggling provider of essential services that don’t get no respect and don’t deserve the meager tax dollars we still pay in. We see this in budget cuts, in hyperbolic allegations of “corruption,” and in disingenuous advocacy for a radical caveat emptor regime for all legal products.

What do we make of these two radically different views of where public health now stands in the public’s regard? My claim is that the former is largely the truth – public health is popular, not despised – but the latter view is what is driving budgets and a lot of policy. The action points follow: a sustained fight to mobilize public support and win more battles over budgets and laws. I see three main strands of work:

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Breaking News on Contraceptive Coverage Mandate

News Release

FOR IMMEDIATE RELEASE
February 1, 2013
Contact: HHS Press Office
(202) 690-6343

Administration issues Notice of Proposed Rulemaking on recommended preventive services policy

The Obama administration today issued proposed rules for public comment regarding contraceptive coverage with no cost sharing under the health care law. The proposed rules provide women with coverage for preventive care that includes contraceptive services with no co-pays, while also respecting the concerns of some religious organizations.

Today’s Notice of Proposed Rulemaking reflects public feedback received through the Advance Notice of Proposed Rulemaking issued in March 2012.  In addition, these proposed rules are open for public comment through April 8, 2013.

“Today, the administration is taking the next step in providing women across the nation with coverage of recommended preventive care at no cost, while respecting religious concerns,” said Health and Human Services Secretary Kathleen Sebelius.  “We will continue to work with faith-based organizations, women’s organizations, insurers and others to achieve these goals.”

The proposed rules lay out how non-profit religious organizations, such as non-profit religious hospitals or institutions of higher education, that object to contraception on religious grounds can receive an accommodation that provides their enrollees separate contraceptive coverage, and with no co-pays, but at no cost to the religious organization.

With respect to insured plans, including student health plans, these religious organizations would provide notice to their insurer.  The insurer would then notify enrollees that it is providing them with no-cost contraceptive coverage through separate individual health insurance policies.

With respect to self-insured plans, as well as student health plans, these religious organizations would provide notice to their third party administrator.  In turn, the third party administrator would work with an insurer to arrange no-cost contraceptive coverage through separate individual health insurance policies.

Insurers and third party administrators would work to ensure a seamless enrollment process. The proposed rules lay out how the costs of both the insurer and the third party administrator would be covered, without any charge to either the religious organization or the enrollees.

Additionally, the proposed rules simplify and clarify the definition of “religious employer” for purposes of the exemption from the contraceptive coverage requirement.  These employers, primarily houses of worship, can exclude contraception coverage from their health plans for their employees.

The proposed rules are available here: http://www.ofr.gov/inspection.aspx

A fact sheet on today’s proposed rules is available here:
http://cciio.cms.gov/resources/factsheets/womens-preven-02012013.html

For more information on women’s preventive services and the Affordable Care Act, visit: http://www.healthcare.gov/news/factsheets/2011/08/womensprevention08012011a.html

Where Are We Now: Post 3, The Agony (and Potential Ecstasy) of Defeat

By Scott Burris

Law has been an extremely effective mode of public health intervention in the last thirty years, which means that proponents of its use have won more than a few tough political battles.  Nonetheless, it is hard to escape the fact that, in recent years, the public health side has been getting killed wherever law is made. The First Amendment turns out to create a right to mine prescription records for data (Sorrell v. IMS Health), advertise liquor prices (44 Liquormart), keep warning labels off cigarette packs (RJ Reynolds v FDA)  – even operate a tattoo parlor in a city that lacks the resources to regulate its safety.  With the Heller case, the strictest forms of gun control were taken off the table, and there is a lot more litigation ahead to define what can be done. The ACA case raises the possibility of future limits on federal regulation via the spending clause. In the latest and most chilling development, the DC Circuit panel in the FDA label case laid the foundation for questioning whether there is even a rational basis for regulations aimed at discouraging people from using “lawful” but dangerous products:

We are skeptical that the government can assert a substantial interest in discouraging consumers from purchasing a lawful product, even one that has been conclusively linked to adverse health consequences.

Things aren’t a whole lot better over in the elected parts of government.  State and local health departments have been experiencing steady budget strangulation ever since (and even before) the Great Recession. The federal life-line, the Prevention and Public Health Fund, was raided once already by Congress, and remains a tempting target. Using the money we do get to promote legal interventions for health is under attack: with the help or acquiescence of Democrats, the long-standing restriction on lobbying in the HHS appropriations bill was changed. Despite legal analysis concluding that the old lines – educating public and policy makers is OK, just don’t push for specific legislation – are still in place, broad language about “future” legislation and threatening letters from an outfit called “Cause of Action” has reportedly chilled a lot of funding recipients.

For many of us, the succession of reverses and cuts looks like public health as usual: public health is usually the underdog whatever the topic. On the other hand, there are arguments that things are different now, ranging from the simple claim that the cuts have now reached bone to the belief that there is an active effort to put the “new public health” entirely out of business. So what is happening?

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