Surrogacy Contracts Directly Enforcible in Pennsylvania

By John A. Robertson

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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Female Viagra: Discrimination or Medicalization or Something Else?

Earlier this year, the flibanserin pill, aka “female Viagra,” was introduced to the market, generating tons of headlines. After many years in which the plain old (male) Viagra was the sole sexual stimulator in the market, flibanserin was finally approved last August, following an 18-6 vote by the FDA advisory committee.

Before approval, flibanserin was rejected twice, and reports say that even members on the advisory board who voted in favor still had misgivings despite their final decision. Their concerns were driven by doubts regarding flibanserin’s effectiveness to treat low sexual drives. Trials showed that women who took the pill ‘earned’ only 0.7 “sexually satisfying events” in a month, whereas the drop-out rate due to negative side effects was relatively high – 14%. The side effects associated with flibanserin are low blood pressure, dizziness and such.

So what made this low cost-benefit ratio get the advisory committee’s approval the third time around? Some credit mass political campaigns promoted by women’s organizations claiming to advocate women’s interests. One position advocated by the organizations presented the pill as a treatment for a legit medical problem called HSDD (hypoactive sexual desire disorder), and it was said to be a step towards realization of women’s sexuality. The other side of the debate pushed back against what they perceive as medicalizing another realm of women’s sexuality and subjecting it (again) to the gaze of the male expert.

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The Common Rule NPRM: Single IRB Review

By: Academic and Clinical Research Group at Verrill Dana LLP

[Crossposted from the The Common Rule NPRM Blog Series on the Endpoints Blog]

To rely or not to rely? Under the recent Notice of Proposed Rulemaking (“NPRM”) issued by the Department of Health and Human Services (“HHS”) and fifteen other federal agencies outlining changes to their existing human subject protection regulations (the “Common Rule”), this would generally no longer be a question in the U.S. Part 2 of our Academic and Clinical Research Group (“ACRG”) blog series on the Common Rule NPRM addresses the NPRM’s proposal to require U.S. institutions engaged in domestic cooperative research to rely on a “single IRB” to provide review of the research on their behalf in most circumstances. This proposal remains a constant from the Advanced Notice of Proposed Rulemaking (“ANPRM”) that was published in 2011, despite comments from the regulated community suggesting that HHS take steps to encourage various types of IRB reliance arrangements but stop short of a mandate. We expect that many institutions may be planning to comment again on whether single IRB review should become a mandate and on the associated relative burdens and benefits of such review (whether it is mandatory or permissive). This blog post does not comment on logistical implementation issues or on the cost assumptions provided by HHS in support of the proposal. Rather, we outline below some additional questions and issues that organizations may wish to consider or address in submitting comments on the proposal.

Thanks to a just-granted 30-day extension of the public comment period for the NPRM, comments on the NPRM are now due to HHS by January 6, 2016. The ACRG has prepared an unofficial redline of the proposed changes against the existing regulations and a set of decision charts to assist with navigating the proposed changes.

ACRG Rapid Rundown: Six Things You Need to Know

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Linda Greenhouse Wins Headline of the Year

By Gregory M. Lipper

“Sex After 50 at the Supreme Court” is the title of today’s Turkey Day column by the peerless Linda Greenhouse. She takes a saucy look at upcoming Supreme Court cases on contraception and abortion and the role of religion in motivating restrictions on reproductive rights and health.

Here’s a taste:

But here’s what’s the same: sex, women and religion.

Among the achievements of the Griswold decision was the separation, as a constitutional matter, of sex from procreation. Although the court viewed the issue through the lens of the privacy of the marital bedroom, that notion of liberty, once established, couldn’t remain confined to husband and wife — nor, eventually, to man and woman.

As we learned from the arguments and dissents in last June’s same-sex marriage decision, the separation of marriage — let along sex — from procreation remains deeply unsettling to segments of the religiously conservative population.

Gobble up the whole column here. Happy Thanksgiving!

Greg Lipper is Senior Litigation Counsel at Americans United for Separation of Church and State. You can follow him on Twitter at @theglipper.

Happy Thanksgiving, Bill of Health Readers

Obama_ThanksGiving_Turkey_Pardon_2009Happy Thanksgiving! Today, we want to give a big thank you to our loyal readers, dedicated bloggers, and excellent commenters. You’ve helped make Bill of Health a tremendous success, and we look forward to continuing to bring you excellent commentary and analysis on all things related to health law policy, biotechnology, and bioethics.

Enjoy the holiday with family and friends!

The FDA de-regulates the first genetically-engineered animal

By Joanna Sax

On November 19, 2015, the FDA de-regulated the AquAdvantage Salmon.  This salmon is genetically engineered to grow faster.  This is the first time the FDA has de-regulated a genetically engineered animal.

Let me just say from the outset that the scientific consensus is clear that genetically engineered food is as safe as conventional food.  Despite the onslaught of public outrage against GMO food, most of the main arguments against GMO food are just hype.

The genie came out of the bottle a long time ago and it’s not going back in.  This happens time and again with scientific advances.   Over the past few decades, our ability to understand, manipulate, edit, and otherwise employ the DNA of various organisms to facilitate human understanding has grown exponentially.  Efforts to resist, combat, or villain-ize the application of biotechnology to impact society might delay, but will not ultimately succeed in keeping the application of scientific discoveries at bay.

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‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14

This week we welcomed W. Nicholson Price, an Assistant Professor at the University of New Hampshire School of Law with a J.D. and Ph.D. (Biological Sciences) from Columbia University. Nicholson’s work on both IP and health care covers a wide array of important issues and was recently featured in a New York Times article.

Nic led off with a tour de force analysis of the recent LabMD decision by an ALJ at the FTC, challenging apocalyptic post-mortems of the case in light of Wyndham & extant FTC common law. Frank riffed on Tim Jost’s recent Health Affairs post on deductibles and legislative rulemaking and called for a bit more service journalism at the New York Times when it covers health and education finance.

We then discussed black box medicine and the new challenges posed to both health and patent law by opaque predictive analytics. Consider, for instance, the challenge in even describing such practices for “written description” purposes. Nicholson offered a big picture view on the relative value of patent and trade secrecy law in incentivizing innovation here.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Vulnerability, Coercion, and Undue Influence: From the Mud into the Muck?

According to the NPRM, “the only vulnerability that needs to be considered is vulnerability to coercion or undue influence, and not other types of vulnerability.” It therefore replaces all standalone uses of “vulnerable” with “vulnerable to coercion or undue influence.” This change is justified on the basis that it will “provide greater consistency and clarity in IRB consideration of vulnerability of subject populations in research activities and appropriate protections,” where the vulnerable populations in question are “children, prisoners, pregnant women, physically or mentally disabled persons, or economically or educationally disadvantaged persons.”

Two provisions of the Common Rule (§107.a and §111.a.3) currently discuss vulnerability without further specification, whereas one (§111.b) discusses vulnerability to coercion and undue influence. Deleting §111.b’s reference to coercion and undue influence, however, would achieve consistency while making even fewer changes than the NPRM proposes. The proposed revisions, then, rest on improved clarity rather than improved consistency.

I doubt that narrowing vulnerability by adding the terms “coercion” and (in particular) “undue influence” adds much clarity. Rather, these changes may reduce protections against research flaws other than coercion and undue influence without offering counterbalancing advantages for the research enterprise. Read More

FDA Releases Report Detailing Problematic Laboratory-Developed Tests

By Rachel Sachs

Last week, the FDA issued a report presenting 20 case studies of laboratory-developed tests (LDTs) that have or may have harmed patients, in support of its ongoing efforts to impose greater regulatory oversight on LDTs.  The report came just before yet another House Energy & Commerce Committee hearing on the issue, and the timing of its release may have been motivated in part by questions FDA officials faced at the last Congressional hearing, about the existing evidence of harm to patients.  The report categorizes the 20 case studies into seven groups, organized by the primary problem posed by the LDT: those with a high degree of false positives (the test yields a positive result when the disease is not present), those with a high degree of false negatives (the test yields a negative result when the disease is present), those which yield both false positives and false negatives, those which test for a factor seemingly unrelated to the disease in question, those linked to treatments based on disproven scientific concepts, those which affirmatively undermined the drug approval process, and of course, “other.”

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Monday, 11/23, HLS Health Law Workshop with Amanda Pustilnik

PustilnikHLS Health Law Workshop: Amanda Pustilnik

November 23, 2015, 5:00 PM
Lewis International Law Center, Room 214A
1557 Massachusetts Ave, Cambridge MA 02138

Download the paper: “And If Your Friends Jumped Off a Bridge, Would You Do It Too?”: How Developmental Neuroscience Can Inform Regimes Governing Adolescents (co-authored with Michael N. Tennison)

Amanda C. Pustilnik is an Associate Professor of Law at the University of Maryland School of Law, where she teaches Criminal Law, Evidence, and Law & Neuroscience. Her current research includes work on models of mind in criminal law, evidentiary issues presented by neuroscientific work on memory, and the role of pain in different legal domains. Prior to joining the University of Maryland, she was a Climenko fellow and lecturer on law at Harvard Law School. Before entering the legal academy, she practiced litigation with Covington & Burling and with Sullivan & Cromwell, where she focused on white collar criminal matters. Prof. Pustilnik also clerked for the Hon. Jose A. Cabranes on the United States Court of Appeals for the Second Circuit. She graduated Yale Law School and Harvard College, and has been a visiting scholar at the University of Cambridge, Emmanuel College, in the History and Philosophy of Science department. Prof. Pustilnik has also worked at McKinsey & Company as a management consultant and is a member of the board of directors of the John Harvard Scholarships. In 2014-2015, Pustilnik was the inaugural Senior Fellow in Law and Neuroscience at the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at MGH and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.