Category Archives: First Amendment

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

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[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

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[Posted on behalf of W. Nicholson Price II, Academic 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

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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

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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

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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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Who Pays? The Wage-Insurance Trade-off and Corporate Religious Freedom Claims

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By Elizabeth Sepper

Happy new year to all and thanks to the Bill of Health for the opportunity to blog this month!

The first day of 2013 saw yet another ruling in the contraception coverage controversy.  And yet another private corporation—this time a real estate management company owned by the billionaire founder of Domino’s pizza—won a temporary injunction against the mandate on religious freedom grounds.  The company’s claim boils down to this:  the Affordable Care Act forces it to pay, through its insurance plan, for healthcare (in this case contraception) to which it objects as a matter of religion.  Let’s bracket, for the moment, the question of whether an artificial entity can have religious beliefs, let alone a conscience, and ask “what wrong with this argument?”

At heart, it misses a basic fact of health economics:  health insurance, like wages, is compensation that belongs to the employee.  Study after study shows that employers pay in wages whatever they don’t pay in health insurance premiums.  Most recently, a study of Massachusetts’ health reform found that firms offering health insurance pay wages lower by an average of $6,058 (nearly exactly the cost of annual health insurance premiums).  Each employee’s actual “salary” is wages plus the employer share of the health insurance premium.  So, when a corporation purchases a health insurance plan that its employees (and their family members) may or may not use to buy contraception, it is no more paying for contraception than it does when employees use their wages to buy it.

Unfortunately, this basic fact about employer-sponsored insurance is invisible to the public.  Employees are ignorant of the effects of insurance on wages and see insurance as a gesture of goodwill with employers reaping the benefits.  This year for the first time, W-2s must list the total annual premium paid toward health insurance (thanks to the Affordable Care Act).  It’s a first step.  But I suspect that it will do little to change our societal perception of employer-sponsored insurance.  In the litigation over contraceptive coverage, I fear that courts may continue to overlook the fact that insurance (and the healthcare it buys) is paid for by employees, not employers.  If so, the courts will only open the door to future challenges to employees’ healthcare decisions, whether paid for with insurance or wages.

BU Law Conference on New Legal Challenges to Global Tobacco Control, Jan. 25, 2013

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Boston is a great city for health policy. On Jan. 25, BU Law hosts a conference on New Legal Challenges to Global Tobacco Control. Just a month later, Harvard hosts its own conference on the Global Governance of Tobacco (details here).

The BU Law conference  (announcement here; detailed schedule here) will focus on challenges rooted in constitutional law (First Amendment litigation in the US attacking FDA-required graphic images on tobacco packs); trade mark law (plain packaging in Australia); and global trade and investment treaties such as the Hong Kong-Australia Bilateral Investment Treaty and the WTO Agreements.  Speakers include some of the world’s leading public health experts on this topic:

  • Matthew Allen, Allen + Clarke Policy and Regulatory Specialists
  • Micah Berman, New England School of Law
  • Scott Burris, Temple University Beasley School of Law
  • Julien Chaisse, The Chinese University of Hong Kong
  • Richard Daynard, Northeastern University School of Law
  • Samantha Graff, NPLAN
  • Jane Kelsey, University of Auckland Faculty of Law
  • Lara Khoury, McGill University Faculty of Law
  • Mark Levin, University of Hawai’i at Manoa William S. Richardson School of Law
  • Jonathan Liberman, Cancer Council Victoria
  • Benn McGrady, Georgetown University Law Center
  • Ted Mermin, Public Good Law Center
  • Kevin Outterson, BU School of Law
  • Robert Stumberg, Georgetown University Law Center
  • Allyn Taylor, Georgetown University
  • Tania Voon, University of Melbourne Law School
  • George Annas, BU School of Law and BU School of Public Health
  • Leonard Glantz, BU School of Law and BU School of Public Health
  • Wendy Mariner, BU School of Law and BU School of Public Health
  • Alexandra Roberts, BU School of Law
  • Keynote Speaker: Dr. Michael Siegel, BU School of Public Health

The conference is open to everyone; see the schedule for details. The conference papers will be published in the American Journal of Law & Medicine.

Bad to the Bone

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I just came across this excellent story by Mina Kimes, which gives a detailed chronicle of how the lines between physician discretion, off-label promotion, and human subjects research can be blurred by an aggressive manufacturer, in a context where life or death is on the line (bone cement used in spine surgery).  The article also suggests themes about medical malpractice, products liability, and physicians’ conflicts of interest too.

First Amendment & Pharma: Taking Freedom of Information Seriously

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By Frank Pasquale

Back in 2011, the AJLM had a symposium issue anticipating major issues in 1st Amendment limits on FDA restrictions on off-label marketing. It was a prescient move, as Prof. Robertson’s post shows. Just as it did in Sorrell, the Second Circuit is using free speech jurisprudence to significantly expand pharmaceutical companies’ freedom of action to promote drugs:

The ruling, in United States v. Caronia, involved the conviction of Alfred Caronia, a former sales representative for Orphan Medical, which was later acquired by Jazz Pharmaceutical. Mr. Caronia was selling Xyrem, a drug approved for excessive daytime sleepiness, known as narcolepsy. He was accused of promoting it to doctors as a treatment for insomnia, fibromyalgia and other conditions. . . .

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Court Says Off-Label Promotion is Legal, and the Difference Between Warrant and Truth

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Invoking the First Amendment protection of speech, the Second Circuit today reversed a criminal conviction for a drug salesman’s promotion of a drug beyond its FDA-approved uses.  The case in U.S. v. Caronia; the opinion is here, and here’s the Reuters story.

In First Amendment cases like Western States Medical Center and Sorrell v. IMS, the Supreme Court has been nibbling around the edges of the FDA’s regulatory regime, but nobody — not the industry, the FDA, or the Supreme Court — has seemed eager to really take it on directly.  For decades the FDA has relied on the regulation of speech as a primary tool.  Those regs turn on the distinction between drugs’ on-label uses (for which companies can promote) and off-label uses (for which companies are not allowed to promote, since the companies have declined to prove to the FDA that the drug is safe and effective for those uses).  Physicians are free, however, to use drugs off-label, so the crux of the FDA regulation really is about whether the company can talk about (promote) a transaction that is otherwise perfectly legal.  With Caronia, the Second Circuit is striking right at the heart of this regulatory regime.

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Tobacco Companies Must Punch Selves in Face, Court Orders

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The Washington Post covers a new order by DC district court judge Gladys Kessler, arising out of an old RICO case brought by the federal government, requiring that the tobacco companies publish advertisements to confess publicly that they previously lied about the safety of smoking and manipulated cigarettes to make them more addictive.  I have pulled the district court order and posted it here, along with this appendix.  The order provides the exact language of the mandated advertisements, but no analysis.  Below the fold, I trace the convoluted path this case and a related case have taken through the compelled speech doctrine around the First Amendment, all thanks to a single judge on the Court of Appeals.

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WaPo on Industry Influence of Clinical Trials

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The Washington Post has an extensive story about the drug and device industry’s influence on the outcomes of clinical trials, which are published in leading medical journals and which then shape the prescribing decisions of physicians everywhere.  Below the fold, I share some of my own thinking on this issue, and link to some of my relevant publications.   Continue reading →

Another Contraceptives Mandate Case

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Following up on Chris Robertson’s and Kevin Outterson’s posts below (here and here), I just wanted to draw your attention to another federal district court opinion on the contraceptives coverage mandate.  This one is from Nov. 19 and involves the owners of Hobby Lobby.  The court denied their motion for a preliminary injunction on the following grounds:

Plaintiffs have not demonstrated a probability of success on their First Amendment claims. Hobby Lobby and Mardel, secular, for-profit corporations, do not have free exercise rights. The Greens [the individual owners] do have such rights, but are unlikely to prevail as to their constitutional claims because the preventive care coverage regulations they challenge are neutral laws of general applicability which are rationally related to a legitimate governmental objective.

Plaintiffs also have failed to demonstrate a probability of success on their Religious Freedom Restoration Act claims. Hobby Lobby and Mardel are not “persons” for purposes of the RFRA and the Greens have not established that compliance with the preventive care coverage regulations would “substantially burden” their religious exercise, as the term “substantially burdened” is used in the statute. Therefore, plaintiffs have not met their prima facie burden under RFRA and have not demonstrated a probability of success as to their RFRA claims.

There are tens of cases challenging the contraceptives mandate pending at the moment, and several have already been dismissed on procedural grounds.  But my current count of the substantive cases is 3 preliminary injunctions granted (Newland, Weingartz Supply, and Tyndale House Publishers), 1 denied (Hobby Lobby), and 1 case holding outright that the mandate violates neither the First Amendment nor RFRA (O’Brien).  Have I missed any?

More religious objections to contraception coverage

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I wrote last week (at TIE) that corporations might have First Amendment or RFRA religious rights to object to contraception coverage. Now we have a second federal judge agreeing, this time on behalf of Tyndale Bible Publishers (complaint here; preliminary injunction here). The short answer:

The plaintiffs have therefore shown that the contraceptive coverage mandate substantially burdens their religious exercise.

The Tyndale opinion again focuses on the rights of the owners of the company (here, a family foundation) rather than the company itself:

This Court, like others before it, declines to address the unresolved question of whether for-profit corporations can exercise religion within the meaning of the RFRA and the Free Exercise Clause. See, e.g., First Nat’l Bank v. Bellotti, 435 U.S. 765, 777–78 n.14 (1978) (recognizing that corporations have First Amendment speech rights, but declining to “address the abstract question whether corporations have the full measure of rights that individuals enjoy under the First Amendment”); Stormans, Inc. v. Selecky, 586 F.3d 1109, 1119 (9th Cir.2009) (“We decline to decide whether a for-profit corporation can assert its own rights under the Free Exercise Clause …”); Church of Scientology of Cal. v. Cazares, 638 F.2d 1272, 1280 n.7 (5th Cir.1981) (same). Instead, the Court will assess whether Tyndale has standing to assert the free exercise rights of its owners…

Viewing the rights of Tyndale’s owners (in particular, those of the Foundation) as the basis for its RFRA claim, the Court finds that Tyndale has made a satisfactory showing of Article III standing.

The court also found “third party standing”

It bears emphasizing that if the Court accepted the defendants’ position, no Tyndale entity would have standing to challenge the contraceptive coverage mandate—not even the Foundation. This is because, in the defendants’ view, Tyndale—though directly injured by the regulation—cannot exercise religion, and the Foundation—though capable of exercising religion—is not directly injured by the regulation. The third-party standing doctrine serves to avoid such conundrums.

These cases are serious, but the threat is to mandatory contraception coverage, not the entire ACA.

Cross-posted from TIE

@koutterson

Opinion granting preliminary injunction on contraceptive coverage mandate

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Yesterday (Friday Nov 16), U.S. District Judge Reggie Walton granted a preliminary injunction barring enforcement of the contraceptive coverage mandate that was part of the regulations implementing the Affordable Care Act (ACA).  There is lots of news coverage (e.g., HuffPo and WaPo), but as usual, the news organizations do not link to the opinion.  For your convenience, I’ve linked to it in the prior sentence, and provide some very preliminary observations below the fold.

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The Contraceptives Coverage Saga Continues…

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Well, hopefully we’ll know the fate of the ACA by tonight.  But even if President Obama wins, there will still be uncertainty about the fate of the contraceptives coverage mandate.

A number of employers claim that the mandate violates their rights to religious freedom by requiring them to offer free coverage for medical products and services they find objectionable, and the administration has taken a number of steps to offer accommodations.  But as a neutral law of general applicability, the mandate doesn’t violate the First Amendment under SCOTUS jurisprudence, and even under the Religious Freedom Restoration Act, there’s a strong argument that the mandate is ok, either on the grounds that it does not actually impose a substantial burden on religious exercise or that  it is supported by a compelling government interest.

Nonetheless, federal courts have reached different conclusions as to the mandate’s permissibility.  In July, a federal district judge in Colorado issued a preliminary injunction blocking enforcement of the mandate against a religious employer running a secular (HVAC) business, while in September, a federal district judge in St. Louis rejected a similar challenge by the religious owner of a mining company.  Last week, a federal district judge in Detroit also issued a preliminary injunction against enforcement, indicating that while neither side had shown a strong likelihood of success on the merits, “The loss of First Amendment freedoms, for even minimal periods of time, unquestionably constitutes irreparable injury.”  Several other challenges to the mandate remain pending.

So let’s just add this to the list of uncertainties that will remain after the results of today’s election are in – and to the list of reasons why employer-based health care really ought to be abandoned in favor of a single-payer, public system.

There, now that ought to get some discussion started…