A Circuit Split on Contraceptives Coverage

Perhaps foreshadowed by the dissent in the 10th Circuit that I wrote about here, the 8th Circuit has now officially launched a circuit split regarding the legal validity of the accommodation that allows modified compliance/objection to the contraceptives coverage mandate.  Unlike the seven other circuits to have considered the question since Hobby Lobby, the 8th Circuit yesterday issued opinions upholding preliminary injunctions in two cases (here and here), thereby preventing the mandate+accommodation from being enforced against the objecting non-profits.

First, the 8th Circuit determined that the accommodation still substantially burdens objectors’ religious beliefs because it imposes significant financial penalties if they refuse to comply with a requirement that they view as violative of those religious beliefs. As I explained previously, I do think the court was right to focus on the monetary consequences of objection, rather than assuming that merely filing the required paperwork for an accommodation does not or cannot actually make objectors complicit in the way they claim it does.

Like SCOTUS in Hobby Lobby, the 8th Circuit then went on to assume that the contraceptives coverage mandate advances a compelling government interest, which is the next step in the analysis under the Religious Freedom Restoration Act once the substantial burden test is met.  So far, so good.  But that’s the end of my agreement.

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I Concur with the Dissent (or, More on Little Sisters)

On September 3, the 10th Circuit declined to rehear en banc several challenges to the contraceptives coverage mandate filed by non-profit organizations, including Little Sisters of the Poor. As SCOTUSBlog explains, these organizations had not themselves asked for en banc review, having already moved on to SCOTUS, but the judges have the option of calling for a vote themselves, which one or more of them must have done.  The vote came down 7-5 in favor of refusal, with the dissenting judges (i.e., those who wanted en banc review) issuing an explanation of their position.  On this issue, I concur with the dissent.  But I still don’t think the objecting non-profits should be off the hook.

When it comes to the contraceptives coverage mandate, non-profits, and now certain for-profits, are accommodated such that they may be relieved of the responsibility to contract, arrange, pay, or refer for contraceptives coverage if they notify the government or their health insurer of their objection to doing so, such that their insurer (or third party administrator of self-insured plans) can provide free contraceptives to their employees, at no cost to and without the involvement of the employer (all further explained here by Greg Lipper).  However, many organizations continue to argue that the accommodation fails to relieve them of complicity in providing contraceptives against their religious beliefs.  They want flat out exemption from the mandate. Continue reading

Pinker on the “moral imperative” for bioethics

In his stunning Op-Ed in today’s Boston Globe, Steven Pinker seems to suggest that bioethicists come in only one flavor: conservative. I certainly don’t fit that bill. But there’s a lot I think he gets right in this critically important piece. Why not change the default rules: what if new scientific advances were welcome, unless we had strong reason to worry, rather than the other way around?

Take a look, this is really important.

Update, 8/6/15: Many people have voiced strong objections to Pinker’s piece, taking his admonition that “the primary moral goal for today’s bioethics” should be to “[g]et out of the way” as squarely directed at IRBs.  His statement was definitely overbroad, but I didn’t take him to mean that we don’t need IRBs or human subjects protection at all.  In fact, he explicitly acknowledges that “individuals must be protected from identifiable harms” and recognizes the importance of existing safeguards for subject safety and informed consent. Instead, I read his piece not just with human subjects research in mind, but all of science. At the most basic level, I think he is making a very reasonable call for us to be aware of the risks of overprotection, of trying to imagine everything that could ever go wrong, with blinders on to the consequences of what will happen if we sit still, worrying for too long.

Some other reactions from around the web:



Another Opinion Upholding the Contraceptives Coverage Accommodation

Today, the 10th Circuit issued its opinion in the Little Sisters of the Poor case, holding that the accommodation offered to religious nonprofits – and now also to certain closely-held for-profits – is legally acceptable under the standard imposed by the Religious Freedom Restoration Act (RFRA).  The accommodation, just recently finalized in its current form, allows eligible employers to avoid covering contraceptives for their employees so long as they notify their insurer or the government of their religious objection to doing so. Importantly, employees are still legally guaranteed access to free contraceptives through alternate mechanisms, usually the via insurer directly.

The 10th Circuit’s opinion represents the fifth win for the administration on the accommodation issue following Hobby Lobby. (Note that Hobby Lobby was about an employer who was not previously eligible for the accommodation.)  The RFRA standard provides that the government “may substantially burden a person’s exercise of religion only if it demonstrates that application of the burden to the person—(1) is in furtherance of a compelling governmental interest; and (2) is the least restrictive means of furthering that compelling governmental interest.”

In Little Sisters, the 10th Circuit dispensed with the RFRA claim by holding that there was no substantial burden, one of the threshold questions in the RFRA analysis.  It explained that the fact of the employer’s opt-out does not *cause* contraceptives coverage (i.e., by requiring another party to provide coverage in their stead), which instead is mandated by federal law.  It also determined that there is no substantial burden from complicity in the overall scheme to deliver contraceptive coverage, i.e., by delivering notice of objection, because their only involvement in the scheme is the act of opting out.  Thus, RFRA’s protections were not implicated, and the accommodation can stand.

I fully agree with the result in this case, but would have gotten there another way.

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New HHS Rules on Contraceptive Coverage

Today, HHS released new final regulations further clarifying the contraceptives coverage mandate.  I have not had the chance to fully digest these, but you can read them here.

Key nuggets, pulled straight from the text:

  • These final regulations continue to allow eligible organizations to choose between using EBSA Form 700 or the alternative process consistent with the Wheaton interim order. The alternative process provides that an eligible organization may notify HHS in writing of its religious objection to covering all or a subset of contraceptive services. The notice must include the name of the eligible organization and the basis on which it qualifies for an accommodation; its objection based on sincerely held religious beliefs to covering some or all contraceptive services, as applicable (including an identification of the subset of contraceptive services to which coverage the eligible organization objects, if applicable); the plan name and type (that is, whether it is a student health insurance plan within the meaning of 45 CFR 147.145(a) or a church plan within the meaning of ERISA section 3(33)); and the name and contact information for any of the plan’s third party administrators and health insurance issuers.
  • [T]hese final regulations extend the [existing] accommodation to a for-profit entity that is not publicly traded, is majority-owned by a relatively small number of individuals, and objects to providing contraceptive coverage based on its owners’ religious beliefs. This definition includes for-profit entities that are controlled and operated by individual owners who are likely to have associational ties, are personally identified with the entity, and can be regarded as conducting personal business affairs through the entity. . . . Based on the information available, it appears that the definition of closely held for-profit entity set forth in these final regulations includes all the for-profit corporations that have filed lawsuits alleging that the contraceptive coverage requirement, absent an accommodation, violates RFRA.

The upshot(s):

  • The extended accommodation allowing eligible objecting employers to notify the government rather than their insurer directly has simply been changed from an interim to a final rule.  This won’t make the pending non-profit litigation go away because these employers still object to two things: (1) having to provide their insurer’s contact information to the government so the government can notify the insurers of their obligations to provide free contraceptives; and (2) having to continue to maintain relationships with insurers who will provide contraceptives.
  • The extension of the accommodation’s eligibility criteria to include closely-held for-profit employers has now been made official following proposed regulation in the wake of Hobby Lobby. In the interim period after Hobby Lobby, objecting for-profits could simply object and avoid the mandate – and their insurers did not have to step in because the accommodation did not yet apply. Now it does, and these employers will likely raise similar objections to the accommodation as have already been raised by their non-profit counterparts.

Let’s just face it – litigation stemming from the ACA will never go away…

Health Law Year in P/Review: Until Next Year

This new post by Holly F. Lynch, I. Glenn Cohen, and Gregory Curfman appears on the Health Affairs Blog as the final entry in a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

It’s been our great pleasure to collaborate with the Health Affairs Blog on this series stemming from theThird Annual Health Law Year in P/Review symposium at Harvard Law School. This annual event takes a look back over the prior year and previews the year to come with regard to hot topics in health law.

After the symposium, we asked our speakers to keep the conversation going online by expanding on their topics from different angles or by honing in on particularly intriguing features. These pieces were published on the Health Affairs Blog through the spring and into summer.

We heard more from Kevin Outterson on how to promote innovation in the development of new antibiotics, from Rachel Sachs on whether the Food and Drug Administration’s proposal to regulate laboratory-developed tests will really stifle innovation, and from Claire Laporte on the impact of recent Supreme Court decisions on bio-IP.

George Annas weighed in on the Ebola outbreak, which has already almost faded from public consciousness but offers important public health lessons, while Wendy Parmet and Andrew Sussman tackled important developments in tobacco control. […]

Read the full post here.

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.

Vaccines and Spying

The NY Times is reporting that the CIA has banned its “operational use” of vaccination programs, which came to light in the context of the hunt for Osama bin Laden. As if it weren’t already hard enough to launch successful vaccination campaigns (domestically and globally), this vaccination+spying taint has surely added further obstacles. And while it’s great to have an affirmative statement that the program has been stopped, significant damage has already been done – trust has already been lost, and it will be incredibly difficult to get skeptical populations back on board. Unfortunately, a statement from the spy promising not to spy anymore isn’t likely to do much. We’ve seen lasting impact of the Wakefield paper linking vaccines to autism, despite its retraction and extensive repudiation – the long term global impact of the CIA’s program could be even worse, with refusal to participate in vaccination programs compounded by violence against public health workers accused of covert activity. Put this alongside physician involvement in executions under the heading: “Ways Not to Mix Medical and Non-Medical Objectives.”

#BELHP2014 Plenary 3, Michael Hallsworth, UK Behavioral Insights Team

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: “Behavioral Economics, Law, and Health Policy.”  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

Today’s lunchtime plenary, Applying Behavioural Insights in Theory and in Practice, was presented by Michael Hallsworth, Principal Advisor, The Behavioural Insights Team (BIT)

Michael described the BIT as a “social purpose” company, originally founded within the UK government, but separated from it (in part) in February 2014.  The company is now partly owned by government, partly owned by its employees, and partly owned by the innovation charity, Nesta.  Michael indicated that when the Team was started, there was genuine doubt about whether behavioral interventions could make a difference or whether this was just a trendy new fad.  The Team responded by implementing rigorous methods of testing, measuring, and evaluating its proposals.

What does the BIT do?  Michael explained that its goal is to incorporate empirical findings about behavior into policy making. Although it has been colloquially referred to as the “Nudge Unit” and Richard Thaler does indeed advise them, the BIT is not actually a nudge unit.  Its first question is not how to nudge but rather how to solve policy problems.  It is a fact that policy tends (and is intended to) influence behavior.  Behavioral insights can allow governments and other policymakers to enhance and assess policy options, and offer new ones.  Put another way, Michael explained that there is not a distinction between policy-making and influencing behavior, they are one and the same.

Michael also argued that we should use behavioral insights as a lens through which to see all government action.  Moreover, whenever the government has decided to act, it should do so in way that it is actually most effective; there is a moral duty to maximize effectiveness and to spend limited government resources wisely.

Michael then went on to describe seven different ways of applying behavioral analysis to show that the best option is to:

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#BELHP2014 Panel 5, Behavioral Economics and the Doctor-Patient Relationship

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: “Behavioral Economics, Law, and Health Policy.”  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

This session was kicked off by Jennifer Zamzow, Post-Doctoral Fellow, Center for Ethics and Policy, Carnegie Mellon University, with a talk called “Affective Forecasting in Medical Decision-Making: What Do Physicians Owe Their Patients?”  Jennifer began with an example of a recently paralyzed patient requesting termination of life-sustaining care on the grounds that his injury feels like a fate worse than death.  On the one hand, we feel compelled to respect the decisions of competent patients, but on the other hand, given what we know about errors in affective forecasting, we anticipate that the patient would be able to eventually adapt to his new circumstances and lead a happy, full life.  The question, then, is whether physicians have any obligation to help their patients make more accurate affective forecasts.

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Public Briefing on Contraceptives Coverage Mandate from KFF

For those of you following the contraceptives coverage mandate litigation:

Later this month, the Supreme Court will hear two cases from for-profit corporations, Hobby Lobby Stores and Conestoga Wood Specialties, challenging the Affordable Care Act’s (ACA) requirement to cover contraceptives on religious grounds. On Tuesday, March 11, two weeks before the hearings, the Kaiser Family Foundation will host a public briefing and panel discussion from 9:30am-11:00am ET in its Washington, DC office to discuss the implications of these court cases on the ACA, corporate and individual religious protections, and civil rights. For those unable to attend, a live webcast will be hosted on kff.org.

Speakers include:

Welcome and Introduction Alina Salganicoff, Ph.D. (Moderator),Vice President and Director, Women’s Health Policy, Kaiser Family Foundation

An Overview of the Contraceptive Coverage Requirement and Legal Challenges Laurie Sobel, J.D., Senior Policy Analyst, Women’s Health Policy, Kaiser Family Foundation

The Religious Freedom Restoration Act and its Application to These Cases Marci A. Hamilton, J.D., Paul R. Verkuil Chair in Public Law at the Benjamin N. Cardozo School of Law, Yeshiva University

Possible Rulings and Outcomes Tom Goldstein, J.D., Publisher SCOTUSblog, Partner Goldstein & Russell, P.C.

Panel Discussion on Implications

Tuesday, March 11, 9:30am-11:00am ET, (Registration and breakfast beginning at 9:00am)

Where: Barbara Jordan Conference Center, Kaiser Family Foundation Offices, 1330 G Street, NW, Washington, D.C., (one block west of Metro Center)

RSVP: Please register online to attend this event in person.

Live Webcast: A live webcast will be available on kff.org.

A solution to the contraceptives coverage mess?

While prepping for a guest lecture on the contraceptives coverage mandate currently before SCOTUS, I had the opportunity today to review the merits briefs filed in the Hobby Lobby case.  I think both petitioners and respondents put out their absolute strongest arguments, as one would expect at this highest level of review.  The government asserts a fairly convincing case that for-profit corporations were not meant to be covered by the Religious Freedom Restoration Act (RFRA) and that individual shareholders are not burdened by the mandate, and the respondents convincingly argue that RFRA does indeed apply and the numerous exemptions already offered by the government have eviscerated any claim that refusing religious exemptions to for-profit corporations is necessary to achieve a compelling government interest.

The respondents, Hobby Lobby and its family owners, articulate a variety of less restrictive alternative methods to achieve the government’s interest in promoting public health and gender equality, including having the government provide free access to contraceptives rather than demanding that employers do so. Interestingly, however, the respondents do not suggest simply extending the existing accommodation available to religious non-profits to for-profit corporations with religious objections.  This accommodation allows a religious non-profit that objects to contraceptives to sidestep the mandate, instead requiring that its insurance company exclude contraceptives from the employer’s plan and itself bear responsibility to provide preventive services without cost-sharing.   The rationale is that it should be at least cost-neutral for insurance companies to provide this coverage, on the grounds that preventing pregnancy is cheaper than covering new dependents.  (And for self-insured plans, there is a similar approach by which third party administrators bear the burden, and are compensated via adjustments to Exchange user fees.)

I can’t be certain why the respondents omitted this obvious alternative, but one possibility has to do with the fact that the accommodation is currently being challenged (e.g., by the Little Sisters of the Poor) as insufficient because objecting employers argue that they are still being required to facilitate access to objectionable services, even if they do not have to pay for them.

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Peter Singer on BatKid

This is worth a read, and, in my opinion, absolutely right.  The discussion is relevant to broader questions of identified v. statistical lives, as well as “choice architecture” questions about how charities ought to seek out donations.  Take a look:

Heartwarming causes are nice, but let’s give to charity with our heads

Full disclosure: Several years ago my family took advantage of a Make-A-Wish trip resulting from my younger brother’s leukemia.  He is now a thriving adult and doing great, and the experience was incredible, especially for those families with children facing terminal diagnoses.  But the fact remains that this really has to be seen as a “luxury” charity – and when faced with a stark side-by-side choice of where the dollars could be spent, Peter’s analysis nails it.

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.

SCOTUS and the Contraceptives Coverage Mandate

As everyone and their brother expected, SCOTUS has just decided to take up two cases challenging the contraceptives coverage mandate: Hobby Lobby, in which the 10th Circuit ruled in favor of the religiously-objecting (but secular, for-profit) employer, and Conestoga, in which the 3rd Circuit went the other direction, maintaining that “for-profit, secular corporations cannot engage in religious exercise.”

I think the First Amendment piece of this is pretty much open-and-shut: the requirement that employers offer health plans that provide contraceptives coverage free of charge is pretty clearly neutral and generally applicable.  Arguments around the Religious Freedom Restoration Act are much more interesting.  For our non-lawyer readers, the basic idea behind RFRA is that the federal government may not (1) substantially burden the right to free exercise of religion, unless it does so (a) in furtherance of a compelling interest, and (2) using the least restrictive means.  This is a high hurdle, otherwise known as strict scrutiny.

You can see several clear decision points under the RFRA analysis, and pretty much any one of them could go either way:

Do for-profit corporations have a right to free exercise?

As a threshold matter, RFRA offers protection only to those entities with free exercise rights.  Citizens United tells us that “corporations are people, my friend.”  So if that analysis applies to both the First Amendment’s free speech rights and free exercise rights, then corporations can at least pass go.  On the other hand, some courts have maintained that religion can only be exercised by individuals or religious organizations, such that RFRA would not apply to secular, for-profit corporations.

Does the contraceptives mandate impose a substantial burden? 

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Fertility and Divorce

In case you missed it, NYT had an interesting Op-Ed on Friday that addressed the inclusion of money for fertility treatments in divorce settlements – and made some suggestions about how to address fertility issues in prenups. Take a look here.

As prices drop, I wonder if/when it will become commonplace for women to start banking some “just in case” eggs in their early twenties as a matter of course. Some eager-to-be grandparents have already started the trend.

More Commentary on Why Patients May Be Discriminated Against

Given my recent piece in the New England Journal on discrimination against patients, particularly obese patients in the context of the Americans with Disabilities Act, I found this NY Times story particularly interesting: Disability and Discrimination at the Doctor’s Office. The Times story focuses on patients who are disabled in more traditional ways, but indicates that the main culprit behind the medical discrimination they may experience is not animus, but rather lack of proper equipment, which can be quite expensive.  Luckily, there may be hope on the horizon, thanks to the ACA.

Tough Advice to Swallow from the NYT Ethicist

Take a look at the answer this physician received about breaking his promise of confidentiality to a patient.  The New York Times’ Ethicist describes this as a modern problem, but it seems to me this is age-old.  And although the confession was not medical, the nature of the doctor-patient relationship and the historical trust it has cultivated can’t be ignored.  The Ethicist says he expects vehement disagreement, and that’s one thing he’s right about for sure.

Live Blogging FDA in the 21st Century Conference, Panel 9 – Addressing the Challenges of and Harnessing New Technologies

Last but not least!  Our final conference panel focused on “Addressing the Challenges of and Harnessing New Technologies,” and was moderated by Fran Miller.

We heard first from Margaret Riley on “Twenty-First Century Technology with Twentieth Century Baggage: FDA Regulation of Regenerative Medicine.”  Riley explained that regenerative medicine (i.e., the use of pluripotent stem cells) has the potential to cure disease, injury, and even remedy organ shortages.  Of course, it is a hugely political issue and the debate is emotional, value-laden, and not necessarily logical.  As a result, the legislation/regulation that results in this area may be far from ideal.

Focusing on FDA specifically, Riley explained that the agency’s approach to stem cell regulation is rooted in its regulation of gene therapy and tissue products, as initiated in the 1990s.  FDA’s regulation of autologous stem cell therapies – in which a person’s own cells are removed, manipulated, and reintroduced – as a drug was recently upheld by the District Court of DC (US v. Regenerative Sciences, 878 F. Supp. 2d 248 (DDC 2012)), but is now on appeal to the DC Circuit. Riley is not sure what the outcome will be on appeal, but noted that getting BLA’s approved on a doctor-by-doctor basis will be very difficult and likely impossible.  One possible outcome of FDA regulation is likely to be off-shoring and stem cell tourism; ironically, strict regulation may end up not protecting patients, who will end up going abroad.

Next up was Nathan Cortez, who asked “Is the FDA Equipped to Regulate Mobile Health Devices?”

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