NIH Announces Plans for new Rules for Funding Chimera Research (Human-Animal Mixtures)

As reported by Science, today the NIH announced plans to lift a preemptive year long moratorium on funding chimera research – that which mixes human and animal cells, often at the embryonic stage.

Here is a snippet from the Science article about the new proposed NIH process:

According to two notices released today, NIH is proposing to replace the moratorium with a new agency review process for certain chimera experiments. One type involves adding human stem cells to nonhuman vertebrate embryos through the gastrulation stage, when an embryo develops three distinct layers of cells that then give rise to different tissues and organs. The other category is studies that introduce human cells into the brains of postgastrulation mammals (except rodent studies, which won’t need extra review).

These proposed studies will go to an internal NIH steering committee of scientists, ethicists, and animal welfare experts that will consider factors such as the type of human cells, where they may wind up in the animal, and how the cells might change the animal’s behavior or appearance. The committee’s conclusions will then help NIH’s institutes decide whether to fund projects that have passed scientific peer review.

The devil will, of course, be in the details. It will be interesting to see how much NIH takes a more categorical approach as opposed to more case-by-case rule making like in the Institutional Review Board or ESCRO setting. Continue reading

NOW AVAILABLE FOR PRE-ORDER! Nudging Health: Health Law and Behavioral Economics

This volume, edited by I. Glenn Cohen, Holly Fernandez Lynch, and Christopher T. Robertson, stems from the Petrie-Flom Center’s 2014 Annual Conference “Behavioral Economics, Law, and Health Policy.” Pre-order your copy today!

Nudging HealthBehavioral nudges are everywhere: calorie counts on menus, automated text reminders to encourage medication adherence, a reminder bell when a driver’s seatbelt isn’t fastened. Designed to help people make better health choices, these reminders have become so commonplace that they often go unnoticed. In Nudging Health, forty-five experts in behavioral science and health policy from across academia, government, and private industry come together to explore whether and how these tools are effective in improving health outcomes.

Behavioral science has swept the fields of economics and law through the study of nudges, cognitive biases, and decisional heuristics—but it has only recently begun to impact the conversation on health care. Nudging Health wrestles with some of the thorny philosophical issues, legal limits, and conceptual questions raised by behavioral science as applied to health law and policy. The volume frames the fundamental issues surrounding health nudges by addressing ethical questions. Does cost-sharing for health expenditures cause patients to make poor decisions? Is it right to make it difficult for people to opt out of having their organs harvested for donation when they die? Are behavioral nudges paternalistic? The contributors examine specific applications of behavioral science, including efforts to address health care costs, improve vaccination rates, and encourage better decision-making by physicians. They wrestle with questions regarding the doctor-patient relationship and defaults in healthcare while engaging with larger, timely questions of healthcare reform.

Nudging Health is the first multi-voiced assessment of behavioral economics and health law to span such a wide array of issues—from the Affordable Care Act to prescription drugs.

Read the introduction on SSRN and pre-order your book now!

Whole Women’s Health, First Take: On the Major Victories and On Technocratic vs. Kulturkampf Approaches to Abortion Litigation at the Supreme Court

I have just made my way through all 107 pages of Whole Women’s Health v. Hellerstedt,  the Supreme Court’s decision this morning to invalidate Texas’ H.B. 2 admitting privileges and surgical center regulations as undue burdens on the abortion right. Full disclosure I filed an amicus brief arguing for this result.  The case was 5-3 with Justices Thomas, Alito, and Chief Justice Roberts in dissent.  I am sure I’ll have a lot more to say after I’ve read through the opinion 3 or 4 more times. Here’s what’s clear to me though even on a quick read.

First, this is a major victory for opponents of Targeted Regulation of Abortion Provider (TRAP) laws. Armed with this opinion they will have a much easier time in the lower courts challenging such laws. Among other things,  (1) the Court signals much less deference to legislatures than in Gonzales and prior cases (see p. 21 of Opinion); (2) the Court instructs that “The rule announced in Casey, however, requires that courts consider the burdens a law imposes on abortion access together with the benefits” conferred (p. 19) ; (3) the Court clarifies the “large fraction” language from Casey as to what is an undue burden in a way favorable to opponents of these regulations. Let me quote the majority here:

Casey used the language “large fraction” to refer to “a large fraction of cases in which [the provision at issue] is relevant,” a class narrower than “all women,” “pregnant women,” or even “the class of women seeking abortions identified by the State.” 505 U. S., at 894–895 (opinion of the Court) (emphasis added). Here, as in Casey, the rele- vant denominator is “those [women] for whom [the provi- sion] is an actual rather than an irrelevant restriction.” Id., at 895. (p.39)

Contrast that with Justice Alito’s long discussion in his dissent as to his understanding (with the pizzaz that shows why he is such a good writer) in a footnote:

The Court, by contrast, applies the “large fraction” standard without even acknowledging the open question. Ante, at 39. In a similar vein, it holds that the fraction’s “relevant denominator is ‘those [women] for whom [the provision] is an actual rather than an irrelevant re­ striction.’ ” Ibid. (quoting Casey, 505 U. S., at 895). I must confess that I do not understand this holding. The purpose of the large-fraction analysis, presumably, is to compare the number of women actually burdened with the number potentially burdened. Under the Court’s holding, we are supposed to use the same figure (women actually burdened) as both the numerator and the denominator. By my math, that fraction is always “1,” which is pretty large as fractions go.

Second, it is remarkable how differently these sets of opinions read from, let’s say, the gay marriage cases or even Gonzales v. Carhart. All the opinions, except perhaps Justice Ginsburg’s very short concurrence, are decidedly in the “technocratic” mode of writing as opposed to what we might call the “kulturkampf” mode that characterized much of Justice Scalia’s dissents on these kinds of issues. These opinion are written for lawyers not the public. I would have to do a proper count to be sure but it seems to me that something like 2/3 to 3/4 of the total pages of these set of opinions are devoted to issues that only lawyers will be able to engage in — res judicata/claim preclusion, severability, third-party standing, as-applied versus facial challenges, and the cogency of tiers of scrutiny.

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Surrogacy Contracts, Abortion Conditions, and Parenting Licenses

By Dov Fox

Everything went fine the last time for Melissa Cook, when the 48-year old mother of four carried a child for a family back in 2013 to supplement her office job salary. This time was different. First were the triplets. She had been impregnated with three embryos, created using eggs from a 20-something donor and sperm from the intended father who paid for everything. Then, it was that the man, Chester Moore, turned out to be a deaf 50-year-old postal worker who lived with his parents. Finally, was that Moore asked Cook to abort one of the fetuses. He said that he had run out of money to support a third child and worried the high-risk multiple pregnancy would endanger the health of any resulting children.

Cook, who is pro-life, refused. A battle over parental rights of the triplets, all boys, began even before they were born (prematurely, at 28 weeks). Moore argued that his surrogacy contract with Cook, explicitly enforceable under California law, made clear that he was the sole legal parent. Cook sued for custody, notwithstanding her prior agreement that any children resulting from the pregnancy would be his to raise. She argued that the statute, by authorizing private contracts for gestation of a human being, reduces children to “commodities” for sale, and a surrogate like her to a “breeding animal or incubator.” Continue reading

NPRM Symposium: Quick Take on New Analysis of the Comments on the NPRM to Amend the Common Rule (and the Challenge for Bioethics and the Public)

The Council on Governmental Relations (COGR), with support from the Association of Public and Land-grant Universities (APLU), undertook “to review and analyze the 2,186 public comments submitted in response to the 2015 Federal Policy for the Protection of Human Subjects” or “Common Rule” Notice of Proposed Rulemaking (NPRM).

I am going to discuss some highlights of their just released report, but this is far from exhaustive and you should read the whole report.

For the non-cognoscenti this is the most important revision to the rules for U.S. human subjects research since their inception. The report is largely unfavorable to several key proposed rule changes on my first read, but you should read it yourself to make up your own mind.

I’ll share some choice passages from the analysis

The results of our review (Table 2) find significant opposition to most major proposals, with mixed support for mandated use of a single IRB and extending the Common Rule and greater support for the concept of standard security safeguards. In addition, a number of responses suggested that the NPRM is overly complex, poorly written, and not supported by data; highlighted areas that could have a substantial impact on a final rule but were not included in the NPRM (e.g., proposed security safeguards, a consent template, a list of minimal risk studies and a decision tool); and suggested that some of the proposals would adversely affect human health with little perceived benefit.

Turning to Biospecimens, where we had a conference last year that will soon generate a book with MIT press:

The majority of responses, approximately 1,520, addressed one or more of the proposed changes detailed above involving non-identified biospecimens. Of these responses, 94 – 100% of patients and members of the research community, including researchers, universities, medical centers and industry, opposed the changes. Those commenting suggested that the proposed changes will significantly reduce the availability of biospecimens for research, will have a significant negative impact on medical advances, and will adversely affect human health. Per one patient, “I am asking for life saving policy not life ending policies.” From a biorepository, “Respecting autonomy at the expense of patient lives is a significant ethical concern.”

More surprising was their finding that “Among members of the general public, 55% opposed and 45% supported one or more of the major proposed changes related to biospecimens.” (They do a better breakdown of the various sub-constituencies in the report).

Turning to “broad consent” for biospecimen use:

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TOMORROW, 3/25 in NYC! Book Talk & Panel: FDA in the 21st Century – The Challenges of Regulating Drugs and New Technologies

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FDA in the 21st Century:
The Challenges of Regulating Drugs and New Technologies

March 25, 2016 12:00 PM

92nd Street Y
1395 Lexington Ave. (at 92nd St.), New York, NY

Join co-editors Holly Fernandez Lynch (Petrie-Flom Executive Director) and I. Glenn Cohen (Petrie-Flom Faculty Director) and contributor Lewis Grossman (American University) for a discussion of FDA in the 21st Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press, 2015). This volume stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.

This is a ticketed event. To learn more, visit the 92nd Street Y’s website!

Sponsored by the 92nd Street Young Men’s and Young Women’s Hebrew Association (New York, New York) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Planned Parenthood And Fetal Tissue Sale: Manufactured Controversy And The Real Ethical Debate

This new post by I. Glenn Cohen appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

In 2013 the Center for Medical Progress appeared to have secured tax-exempt status for a fake company it set up called Biomax Procurement Services. The company’s “representatives” contacted the non-profit women’s health provider Planned Parenthood staffers and led them into conversations that were secretly recorded. The result, according to their website (as reported by CNN), was “a 30-month-long investigative journalism study by The Center for Medical Progress, documenting how Planned Parenthood sells the body parts of aborted babies.”

The videos were edited down and released slowly in a way designed to paint Planned Parenthood in the worst light. While some have called it a “hoax,” that’s not a word I would use in this case. When I think of great journalistic hoaxes I think of Orson Welles’s War of the Worlds (though more recent historical work suggests that the panic it caused may have been mythological). Instead what happened here, I want to suggest, is what I will call a “manufactured controversy.” [..]

Read the full post here.

Some Very Preliminary Thoughts on Whole Women’s Health v. Hellerstedt (Texas Abortion Case) Argument

By I. Glenn Cohen

It is always dangerous to try to glean too much from oral argument, and I have only read the transcript (no recording yet) of today’s argument in Whole Women’s Health v. Hellerstedt, and finally I filed a brief in this case on the side of the law’s challengers so I may be suffering from some motivated reasoning. But with all those caveats, here goes:

Justice Scalia’s passing seems to have radically transformed this oral argument and likely this case. The 3 firm anti-abortion votes on the court (Alito and Roberts from their questions and earlier positions, Thomas we can infer from his earlier positions) left over after Justice Scalia’s passing seemed very much to be playing a defensive game. Many of their questions were aimed at convincing others on the Court (especially Justice Kennedy, the swing voter on these matters) to remand the case back to the lower court, much more so than focusing on giving Texas an outright win.

Appellant’s Counsel Toti’s argument barely was able to get to the merits questions in the case. Instead Justices Roberts, Alito, sometimes joined by Kennedy in these questions, repeatedly asked about evidence in the record on when various clinics closed, re-opened, and what evidence there was for the reason behind it. Toti tried to make use of the timing to her advantage as did the Justices more supportive of her side, but there was a lot of push on why this element of the record was not better developed. She was also repeatedly asked questions regarding the evidence on the capacity of remaining clinics to absorb extra patients needing abortions and what was developed in the record.

The same was true to a lesser extent in Appellee’s Counsel Keller’s argument. Justice Kennedy in particular focused on a line of questioning at page 44 of the argument that may also be significant in terms of remanding the case without resolving it:

“But I thought an underlying theme, or at least an underlying factual demonstration, is that this law has really increased the number of surgical procedures as opposed to medical procedures, and that this may not be medically wise?” Continue reading

Does the NAM Recommendation of Sex Selection for Mitochondrial Replacement Therapy Violate the Equal Protection Clause (Part III on my take on the NAM report)

As I said in one of my earlier posts today one of the most interesting parts of the NAM report on mitochondrial replacement therapy was its recommendation that only male embryos be implanted and not female ones. The argument is that this will eliminate the risks of germ-line transmission of anything untoward. I will leave it to others more versed in the risk factors to discuss whether this is an over-reaction (the UK did not adopt this in their recommendation) or reasonable. In the last post I discussed why politically/ethically this may get them in some hot water, but here  I want to raise a different question. Would such a recommendation be unconstitutional?

If FDA were to adopt this rule it would clearly be state action. It seems to be a state-law that favors one gender (males) over another (females) in that only males can be produced in this way. If that is right, under existing Supreme Court precedent it would be judged under “intermediate scrutiny.” To pass intermediate scrutiny, the challenged law must further an important government interest by means that are substantially related to that interest. Would this rule satisfy that test? Continue reading

Breaking News: NAM Releases Report on Mitochondrial Replacement Therapy (Part II My First Take)

By I. Glenn Cohen

My last post was a summary of the NAM’s Recommendations on Mitochondrial Replacement Therapy (MRT). Now here is my take on the report. But keep in mind the report was just released and all I could give it was a quick read, so these are really more like initial impressions: Continue reading

Breaking News: NAM Releases Report on Mitochondrial Replacement Therapy (Part I Summary)

By I. Glenn Cohen

As readers know I’ve written on mitochondrial replacement therapy and its attendant ethical and regulatory issues. Today the National Academy of Medicine (formerly known as the IOM) released a terrific report today with its recommendations. I’ll have a second post with my reactions but here is a summary from the report of their recommendations. The big headline is they have recommended FDA largely move towards allowing it to go forward under a regulatory pathway with restrictions, the most important of which is the transfer only of male embryos (to avoid germ-line issues).

In the NAM’s own words:

Recommendation 1: Initial clinical investigations of mitochondrial replacement techniques (MRT) should be considered by the U.S. Food and Drug Administration (FDA) only if and when the following conditions can be met: Continue reading

Surrogacy Contracts Directly Enforcible in Pennsylvania

Surrogacy is legal in many states.  Some, like California, directly enforce gestational carrier contracts.  Others, like Texas, Illinois, and Virginia, enforce only those contracts that are entered into by a married couple who need a surrogate for medical reasons which a judge approves before embryo transfer occurs.  A Pennsylvania court has now shown why gestational surrogacy contract should be directly enforced in the absence of legislation.  Its well-reasoned opinion suggests that more states may be open to this approach to surrogacy.

The Pennsylvania case, In re Baby S., arose out of a gestational surrogacy agreement involving embryos created with donor eggs and husband sperm. The written agreement was indisputably clear that that the intended parents would be the legal rearing parents, their names would appear on the birth certificate, and the carrier would have no rearing rights or duties.  Unlike previous cases questioning the validity of a surrogacy contract, the challenge here came not from the carrier who now wished to assert rearing rights (see In re Baby M and Calvert v. Johnson) but from the wife (the intended rearing mother).  She had praised the carrier’s willingness to help her have a child, which she repeated both at the embryo transfer and at a 20 week ultrasound at 20 weeks of pregnancy, which both intended parents attended.  A month later she informed the parties that “irreconcilable marital difficulties” would make it difficult for her to co-parent the child with the intended father.  She also refused to complete the paperwork for her name to appear on the birth certificate as the mother.

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Identified versus Statistical Lives at the Movies

Imagine you had 10 million dollars to spend to save the life of one person whose name you knew or 10,000 whose name you didn’t? How would you spend it? What would you think of a government policy that chose to save the 1 person rather than the 10,000? I would think pretty badly of such a government, but that’s exactly what happens in some popular new movies. And the expectation of the filmmakers (and my own take on audience reaction) is that the audience cheers.

sq_martianFirst, The Martian (spoiler alert) where America spends tens of millions and diverts the entirety of the space program to bring back one man left behind on Mars. Second, the new movie 33, which I have not seen yet but is based on a true story involving the successful attempt to save 33 Chilean miners trapped in a mine collapse at a huge financial cost. Continue reading

Book Launch (10/28)! FDA in the 21st Century: The Challenges of Regulating Drugs and New Technologies

lync17118_frontBook Launch: FDA in the 21st Century
October 28, 2015 12:00 PM
Wasserstein Hall, Milstein East C, HLS
1585 Massachusetts Ave., Cambridge, MA [Map]

In September 2015, Columbia University Press published FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies, co-edited by Petrie-Flom Center Executive Director Holly Fernandez Lynch and Faculty Director I. Glenn Cohen. This edited volume stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.

This event will provide a discussion of the book, including questions like: How is the agency faring in the 21st century? What are the greatest challenges to the FDA’s success, and what does success look like? What lessons has it learned and how can it best meet the challenges of today? Should we keep the agency we have, pull it apart, or rebuild from scratch?

Panelists:

  • Daniel Carpenter, Freed Professor of Government, Harvard University and Director, Center for American Political Studies at Harvard University
  • I. Glenn Cohen, JD, Professor of Law and Faculty Director of the Petrie-Flom Center, Harvard Law School (co-editor)
  • Aaron S. Kesselheim, MD, MD, MPH, Associate Professor of Medicine, Harvard Medical School; faculty member, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hosptial
  • Holly Fernandez Lynch, JD, MBioethics, Executive Director of the Petrie-Flom Center (co-editor)
  • Moderator: Ameet Sarpatwari, Instructor in Medicine, Harvard Medical School, and Associate Epidemiologist, Brigham and Women’s Hospital

This event is free and open to the public.

Order the book now from Columbia University Press using promo code FDA21 and save 30%!

Sponsored by the Harvard Law School Library and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

NPRM Summary from HHS

As Michelle noted, the Notice of Proposed Rule Making (NPRM) on human subjects research is out after a long delay. For my (and many Bill of Health bloggers’) view about its predecessor ANPRM, you can check out our 2014 book, Human Subjects Research Regulation: Perspectives on the Future.

Here is HHS’s own summary of what has changed and what it thinks is most important:

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991.  A Notice of Proposed Rulemaking (NPRM) was put on public display on September 2, 2015 by the Office of the Federal Register.  The NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. It is expected that the NPRM will be published in the Federal Register on September 8, 2015.  There are plans to release several webinars that will explain the changes proposed in the NPRM, and a town hall meeting is planned to be held in Washington, D.C. in October. Continue reading

NOW AVAILABLE: FDA in the 21st Century: Get 30% Off When You Order through the Press!

lync17118_frontJust out from Columbia University Press, FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies! This volume, co-edited by Petrie-Flom Center Executive Director Holly Fernandez Lynch and Faculty Director I. Glenn Cohen, stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.

Use promo code FDA21 and save 30% if you order now at the Columbia University Press website!

And join us at Harvard Law School on October 28 for a book launch and panel discussion featuring editors Holly Fernandez Lynch and Glenn Cohen!

Thank you for 3 great years!

Three years ago today, we launched the Bill of Health blog to create a one-stop-shop for readers interested in news, commentary, and scholarship in the fields of health law policy, biotechnology, and bioethics. We have been thrilled at the blog’s success and reach so far.

A few quick stats:

  • We have 90 contributors from 49 institutions around the globe.
  • More than 350,000 unique visitors from more than 200 countries have visited the blog since it was first launched.
  • The blog gets more than 17,000 page views per month.
  • We’ve clocked in over 2,000 blog posts covering a wide range of topics:
    • Health insurance, health care finance, health care reform
    • Reproductive health and rights
    • Pharmaceutical regulation
    • Food safety and regulation
    • Human subjects research
    • Personhood and animal rights
    • General health law, policy, and bioethics

As a sample, here are the top five most viewed posts from each academic year:

2012 – 2013

  1. The High Cost of Health Care: Why Some Pay $240 for a $9 Bottle of Pills, by Jonathan Darrow
  2. Finasteride as an FDA-Approved Baldness Remedy: Is It Effective?, by Jonathan Darrow
  3. Liability for Failure to Vaccinate, by Arthur Caplan
  4. Discrimination in the Doctor-Patient Relationship, by Holly F. Lynch
  5. At $28,000 a Dose, How Effective Is Acthar?, by Jonathan Darrow

2013 – 2014

  1. Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON, by Jonathan Darrow
  2. Taking China’s Food Safety Problem Seriously (I), by Ching-Fu Lin
  3. Medical Marijuana Delivery May Not Be As “Eazy” As It Seems, by Arielle Lusardi
  4. Taking China’s Food Safety Problem Seriously (II), by Ching-Fu Lin
  5. Ethical Concerns, Conduct and Public Policy for Re-Identification and De-identification Practice: Part 3, by Daniel Barth-Jones

2014 – 2015

  1. Highlights from the 21st Century Cures Act, by Rachel Sachs
  2. Savior Siblings in the United States, by Zachary Shapiro
  3. New browser app shines light on conflicts of interest, by Christine Baugh
  4. A New Cholesterol-Lowering Drug at What Price?, by Kate Greenwood
  5. Pain on the Brain: A Week of Guest Posts on Pain Neuroimaging & Law by Amanda C. Pustilnik

Thanks to our many contributors – and to our readers!  We look forward to many more years of growth.  And always, if you have any comments or suggestions, make sure to send them our way: petrie-flom@law.harvard.edu.  Happy reading!

Glenn and Holly 
Bill of Health Co-Editors

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Fetal Personhood and the Constitution

By John A. Robertson

The Rubio-Huckabee claim that actual and legal personhood start at conception has drawn trenchant responses from Art Caplan on the medical uncertainty of such a claim and David Orentlicher, drawing on Judith Thomson’s famous article, that even if a fetus is a person, woman would not necessarily have a duty to keep it in her body.

Their debate claim that the fetus is already a legal person under the constitution also deserves a response, for it has no basis in positive law.  In Roe v. Wade all nine justices agreed that the use of “person” in the Constitution always assumed a born person, and therefore that the 14th Amendment’s mention of person did not confer constitutional rights until after a live birth.  In the years since Roe, when the make-up of the court has changed, no justice has ever disagreed with that conclusion, including those who would overturn Roe and Casey. Continue reading

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.

FDA’s Non-Response Response to My New York Times Op-Ed on Gay Blood Ban

On May 21, along with my frequent co-author Eli Adashi, I published an op-ed in the New York Times raising some questions about FDA’s proposed guidance recommending a ban on taking the blood on any man who has had sex with another man in the past year, or in other words imposing a one year celibacy requirement on gay men if they want to donate blood. This built on our critique last July in JAMA, wherein we argued that FDA’s then-lifetime ban on gay men and MSM donating blood was out of step with science and the practice of our peer countries, as well as potentially unconstitutional.

Thanks to our work, and a concerted effort by public health, medical, and gay rights groups, FDA has finally moved off of that prior policy and recognized that it was unjustified, and discriminatory.

Just to put this in context It took more than 30 years to convince FDA that it was problematic to ban blood donation for a lifetime any man who ever had sex with another man, even if both have repeatedly tested negative for HIV, while it imposed only a one year ban on people who had sex with individuals known to be HIV positive or a sex worker. FDA is appropriately a conservative agency, but on this issue of the lifetime ban its willingness to listen and reconsider has gone beyond conservatism to the point of lunacy. [By the way to be clear, I *love* FDA. I represented them while at the DOJ and have a new book coming out about FDA in the fall. You can think highly of an agency but think they have a bad track record on an issue. This is critique not hater-aide].

Well with that background, one should be not so quick to assume that a move to a one year ban — a de facto lifetime ban for any gay man who is sexually active, even one who is monogamously married with children — is the best policy. To put it bluntly, refusing to change a lifetime ban for such a long period makes me skeptical we should accept a “just trust us” line on their new restrictive policy.

The question we raised in our op-ed was whether FDA had adequately justified retaining a one year ban in light of the evidence from places like South Africa (with a much shorter time period ban), Italy (which does individualized risk assessment instead of stigmatizing all gay men as high risk for disease), etc.

Well FDA responded…sort of … through a NY TImes Letter To the Editor.

Here is what FDA said with my analysis in bold:

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