bioIP Workshop – Deadline for Abstracts Approaching

Call for Abstracts: 2015 bioIP Faculty Workshop

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the first annual bioIP Faculty Workshop on May 7, 2015 at Boston University School of Law.

The Workshop will offer a unique opportunity for three junior scholars (in their first decade of teaching) to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.

Topics for the workshop are at the intersection of biotechnology/life sciences/FDA and IP (hence, bioIP), broadly defined. A Review Committee will select papers for the Workshop in a blind process. Papers should present an original thesis and contribute to scholarly literature. The Workshop will not review published work.

Scholars with less than ten years of teaching experience interested in having their papers reviewed should submit an abstract (up to 750 words) of the proposed paper (without identifying details) along with a c.v. to Ted Hutchinson, Executive Director of the ASMLE at  thutchinson at aslme.org by Oct 1, 2014. Selected abstracts will be announced later in Fall 2014 with the full draft papers due by April 1, 2015. The organizers will cover reasonable travel and lodging expenses. VAPs and Fellows are eligible for the Workshop.

The Workshop Committee consists of faculty from: The Boston University School of Law; Georgia State University College of Law; Indiana University Robert H. McKinney School of Law; and the Loyola University Chicago School of Law.

For questions, please email Kevin Outterson, mko@bu.edu.

AHLA Health Law Curriculum Manual

The American Health Lawyers Association is the nation’s largest group of practicing health law attorneys, with awesome CLE programs.

For the past couple years, a group at AHLA has been evaluating how health law is taught at law schools, with a view to prepare students for the practice of health law. AHLA surveyed many health law practice group chairs and other leaders. With that data, a large group of AHLA members and some full time professors evaluated health law curricula nationwide. A guidance document is now out (html or pdf):

We found some significant gaps, however, between what law schools offer and what the profession hopes to see in new health lawyers. Members of the American Health Lawyers Association (AHLA) want to see more substantive classes in fraud & abuse, business, tax, life sciences, and health care reimbursement. Desired skills include working in teams, processing practical transactional skills, and effectively analyzing client-focused problems.

Two take-away slides from the AHLA survey of health law practice leaders and hiring partners:

Continue reading

bioIP Junior Faculty Workshop: Call for Abstracts by Oct. 1

Call for Abstracts: 2015 bioIP Faculty Workshop

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the first annual bioIP Faculty Workshop on May 7, 2015 at Boston University School of Law.

The Workshop will offer a unique opportunity for three junior scholars (in their first decade of teaching) to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.

Topics for the workshop are at the intersection of biotechnology/life sciences/FDA and IP (hence, bioip), broadly defined. A Review Committee will select papers for the Workshop in a blind process. Papers should present an original thesis and contribute to scholarly literature. The Workshop will not review published work.

Scholars with less than ten years of teaching experience interested in having their papers reviewed should submit an abstract (up to 750 words) of the proposed paper (without identifying details) along with a c.v. to Ted Hutchinson, Executive Director of the ASMLE at  thutchinson at aslme.org by Oct 1, 2014. Selected abstracts will be announced later in Fall 2014 with the full draft papers due by April 1, 2015. The organizers will cover reasonable travel and lodging expenses. VAPs and Fellows are eligible for the Workshop.

The Workshop Committee consists of faculty from: The Boston University School of Law; Georgia State University College of Law; Indiana University Robert H. McKinney School of Law; and the Loyola University Chicago School of Law.

For questions, please email Kevin Outterson, mko@bu.edu.

Halbig is out and the gov’t lost (but long live the King)

My post at TIE: 4.683 million people get tax bills, lose coverage http://theincidentaleconomist.com/wordpress/4-683-million-unanswered-questions-in-halbig/

Also Nick Bagley at TIE: http://theincidentaleconomist.com/wordpress/a-stinging-defeat-for-the-government/

UPDATE: Gov’t wins in the 4th Cir companion case: http://theincidentaleconomist.com/wordpress/the-government-may-have-lost-in-d-c-but-it-just-won-in-the-fourth-circuit/

Public health in the shadow of the First Amendment

The First Amendment has been repurposed as a powerful deregulatory tool, especially in health care (NEJM on data privacy) and public health (NEJM on smoking). Amy Kapczynski at YLS has put together a timely and powerful conference, Public Health In The Shadow of the First Amendment. October 17-18 in New Haven. Register here.

@koutterson

 

Messing with the data, law school edition

(cross-posted from TIE)

One important outcome measure for law schools is employment of their graduates, especially jobs for which bar passage is required and are long-term, full-time jobs (BPRFTLT). If a law school can boost that number, it will appear to be better than its rivals. A job is “long-term” if it is expected to last at least a year. Can you guess what many law schools have done? Hired dozens of their grads for a little more than a year:

  FBPRFTLT2012 / 2013 2012 % of EBPRFTLT 2013 % of EBPRFTLT
GEORGE WASHINGTON 119 / 88 25.5% 20.7%
WILLIAM AND MARY 35 / 43 23.3% 25.9%
UMASS DARTMOUTH 3 / 3 23.1% 10.3%
VIRGINIA 54 / 58 15.7% 16.7%
NYU 58 / 42 13.2% 8.3%
GEORGETOWN 41 / 73 8.9% 13.5%
EMORY 17 / 64 8.7% 26.0%
COLUMBIA 38 / 29 8.7% 7.0%
CHICAGO 17 / 13 8.3% 6.5%
YALE 11 / 9 6.0% 5.6%
ILLINOIS 7 / 20 5.3% 11.9%
MINNESOTA 7 / 5 4.5% 2.6%
HARVARD 16 / 11 3.1% 2.2%
UCLA 7 / 25 2.9% 9.6%
PENN 7 / 13 2.7% 5.5%
STANFORD 4 / 5 2.4% 2.9%
WASHINGTON UNIVERSITY 4 / 4 2.0% 2.0%

(First column is the law school; second is the number of law-school funded jobs that the law school described as bar passage required, full-time, long-term (BPRFTLT) to the ABA for the classes of 2012 and 2013; third and fourth columns are the % of BPRFTLT jobs funded by the school for the classes of 2012 and 2013, respectively. The chart includes all schools in the ABA data set who reported more than 2% BPRLTFT funded jobs for the class of 2012. Schools are ordered descending by column 3. The class of 2013 data was released by the ABA this week.)

Some comments:  Continue reading

The other oral argument on Tuesday

Cross posted from The Incidental Economist:

The opponents of the Affordable Care Act certainly know their way around a courtroom. Oral arguments in the contraception mandate case (Hobby Lobby) will be heard on Tuesday at the Supreme Court. That same day, another challenge will be heard in a federal courtroom nearby, in the Court of Appeals for the DC Circuit (the WSJ photo identifies the wrong court).

To the Cato Institute, the tax credit cases (Halbig v. Sebelius and a related case in the Fourth Circuit, King v. Sebelius) represent their last shot to cripple the four-year-old law by wiping out health insurance subsidies to millions of people in the 36 states that did not create state exchanges. (I’ve blogged about these cases before, and Cato folks have also posted summaries of the anti-ACA amicus briefs. Sunday’s WSJ ran an editorial following the Cato line).

Today, I wanted to highlight the amicus brief filed on Thursday March 20, 2014 by the Commonwealth of Virginia in King v. Sebelius (the 4th Circuit case, not the one up for oral argument on Tuesday). I appreciate the beauty of this argument, for it uses a conservative victory in federalism to support the federal government, and it comes from the newly-elected attorney general who replaced an early opponent of the ACA. (Mark Herring won by only 165 votes, but #electionsmatter).

I’m talking about the Pennhurst doctrine, which requires Congress to give states “clear notice” if conditions on states are attached to federal spending. So Virginia asks the very interesting question: Did Congress give “clear notice” that the penalty for failing to build a state exchange would be the loss of billions of dollars of health insurance subsidies?  When you put it that way, Cato’s argument collapses. From the brief:

For no one can reasonably claim that the federal government gave Virginia clear notice that its citizens would be denied premium tax-credit assistance as punishment for the Commonwealth’s decision to forgo building its own health insurance exchange.

And later:

 [The Plaintiffs argue] that everyone in Congress silently but mistakenly assumed that every State would create its own Exchange. (Appellants’ Br. 6, 42.) That claim finds no support in the record. The ACA was controversial when it was debated and adopted, and it was well known that numerous States objected to it and would not go along willingly.

The brief also notes that no Member of Congress expressed such a view and even the architects of this litigation (Cannon and Adler) were surprised by this “glitch” after the fact. The brief also reviews the official correspondence to and from the Governor on this issue; any notice whatsoever is lacking, much less “clear notice.”

What bothers me the most about this litigation is Cato’s willingness to try to hurt millions of vulnerable people in order to score political points, even after losing the 2012 Presidential election and the first bite of the Supreme Court apple in NFIB v. Sebelius. The Virginia brief puts the emphasis on the people:

Two sovereign interests compel the Commonwealth of Virginia to file this brief. First, the Commonwealth represents the interests of the hundreds of thousands of Virginians who depend on federal premium tax-credit assistance to afford the health insurance that is now available under the Patient Protection and Affordable Care Act of 2010 (the “Affordable Care Act” or “ACA”). Their interests are not represented by the Appellants here, four individual Virginians who do not want health insurance. Second, the Appellants’ legal theory contradicts the fundamental assumption on which the Commonwealth elected to forgo building its own health insurance exchange in favor of a federally-facilitated exchange: that doing so would not harm the interests of Virginians. The Appellants’ theory must be rejected under the Pennhurst doctrine, which prevents Spending Clause statutes like the ACA from being used to impose unusual conditions about which States were not provided “clear notice.” What is more, if Congress had actually done what Appellants claim — made State citizens financial hostages in a scheme to force State governments to adopt State-based exchanges —it would have violated the Tenth Amendment’s prohibition on coercing States to carry out federal policies. Accordingly, this Court should reject Appellants’ arguments and affirm the ruling of the District Court.

h/t Tim Jost

@kevinoutterson

Kevin Outterson on the Search for New Antibiotics

Kevin Outterson appeared on NPR’s “Here & Now” to discuss the growing problem of antibiotic resistance and possible ways to incentivize development of new antibiotics. From the interview:

On the misuse of antibiotics

“We should think of this as a global resource that needs to be conserved and taken care of. So antibiotics should never be used inappropriately. In the country right now, we have something on the order of 23 million people who are getting antibiotics for ear aches. Most of those situations would resolve on their own in a couple of days. We also give antibiotics many times for people just because they have some sort of a common cold — it’s estimated 18 million prescriptions a year — doesn’t help anyone who has the common cold. It’s a complete waste.”

On the rise of antibiotic-resistant bacteria

“It’s frightened people for more than a decade. You mentioned at the top the 23,000 Americans who are dying from resistant infections. The CDC said on top of that, there’s another 14,000 dying from a horrible disease, intestinal disease, called Clostridium difficile [C-diff] in the United States. Together, that’s larger than the number of people who die in this country each year from AIDS. And we’re not — as bad as things are now, the more troubling aspects, or what might happen in five or 10 years if some sort of a pathogen was resistant to everything we had got out to the population. It sounds like a Hollywood movie.”

You can listen to the full interview here.

2/3 Petrie-Flom Health Law Workshop: Paper Now Available

Kevin Outterson will join us on Monday, February 3, for the first spring meeting of the Petrie-Flom Center’s Health Law Policy Workshop. He is a Professor of Law and Professor of Health Law, Bioethics, and Human Rights at Boston University. Professor Outterson teaches health law and corporate law, and his interests include global pharmaceutical markets, finance and organization of health care systems, antimicrobial resistance, poverty tourism, and health disparities. He serves as the editor-in-chief of the Journal of Law, Medicine & Ethics, the faculty co-advisor to the American Journal of Law & Medicine, the immediate past chair of the Section on Law, Medicine & Health Care of the AALS, and a member of the Board of the American Society of Law, Medicine & Ethics. Before teaching, Professor Outterson was a partner at two major U.S. law firms.

His research work focuses on the organization and finance of the health sector. Areas of specialization include global pharmaceutical markets, particularly antibiotics and other antimicrobials that can degrade in usefulness over time through resistance.

On Monday, Professor Outterson will discuss his paper “New Business Models for Sustainable Antiobiotics.” For more information on the Health Law Workshop, including meeting time and location, and to download the paper, please visit our website.

The contraception mandate decision

From my post at The Incidental Economist:

The Gilardi v. HHS decision is out today (on scribd), blocking the PPACA contraception mandate for the plaintiffs. Two brothers own Freshway Foods and a related company that offer a self-insured health plan to their 400 employees. For non-grandfathered plans with an annual enrollment period starting on or after September 23, 2010, PPACA required zero deductibles and cost sharing for a package of preventative services. One component of that package includes FDA-approved contraception. The Gilardi brothers claimed this requirement violates the Religious Freedom Restoration Act (RFFA). A majority of the Court agreed, sending the case back to the District Court for a reconsideration of the injunction.

This case raises an interesting point about pluralism in our society. When do we get to abstain from generally-applicable laws that violate our moral beliefs? Even more attenuated, when do we get to opt out because other people’s actions violate our beliefs? Can the Freshway companies decide to drop hospice care for their employees as violating their Catholic beliefs? Could a Muslim employer prevent employees from bringing home the bacon with their paychecks? Could a Baptist employer fire employees for watching porn at home on HBO?

Continue reading

Empirical proof health law is complex

I hear complaints from time to time about the complexity of health care law. Now we have some evidence.

Katz and Bommarito (gated, free registration) at Michigan State analyzed the US Code for complexity using a variety of big data techniques. The most complex area of US statutory law? Our friend, Title 42, home to Medicare, Medicaid, and the Social Security Act. Title 42 beat (lost?) to tax law by a substantial margin (tax was #2, noted Paul Caron).

But according to Katz (by email), the underlying data is from 2010, before PPACA was codified into Title 42. So health law is in no danger of losing the lead.

@koutterson

How global regulations are written

In secret, during “trade” negotiations. Just one example: the 12 years of data exclusivity for biologics is currently US law, but that may get carved into stone in the new Trans-Atlantic Trade and Investment Partnership (TIIP). Once enshrined in a trade agreement, this rule and thousands more will be immune to change by any national democratic process.

Who participates in this process? Generally, only “cleared advisors” from the Fortune 500.

A partial (leaked) list of the initial bargaining positions for the EU are downloadable here. In the Initial Positions Papers, the EU notes that they have approved 16 biosimilars which have not yet been recognized as such in the US. Other topics include generic approvals, GMP inspections, and regulatory science for drug approvals.

All of decisions have immense potential impact for consumer welfare. My concern is the undemocratic lack of transparency for the entire process.

(cross-posted from TIE)
@koutterson

Politics after a SCOTUS decision

Some SCOTUS opinions stir up politics and legislation (think: Roe v Wade). Others tend to end the process. When the Court is interpreting a federal statute, if they get it “wrong” it is of course possible for the elected branches to reverse them. But for some of these issues, political stalemate in Congress gives the Justices the last word, perhaps for decades.

Which makes the Roberts Court both activist and powerful.

For more, see “Political gridlock empowers US justices” in today’s Financial Times, quoting me.

@koutterson

Health Law Year in P/Review Video

If you couldn’t make it to our inaugural session on Health Law Year in P/Review, co-hosted by the Petrie-Flom Center and the New England Journal of Medicine, you’re in luck!  You can watch the video here:

http://www.law.harvard.edu/media/2013/02/01_pf.mov

Topics and speakers included:

The ACA and Health Care Reform

Contraceptives Coverage and Personhood Amendments

Immigrants’ Access to Health Care

Affirmative Action and Medical School Admissions

Gene Patenting

Tobacco and Obesity Policy and the First Amendment

Summary and Wrap Up

Closing Remarks from Dean Martha Minow

Twitter Round-Up (1/27-2/7)

By Casey Thomson

Even the surprisingly resurrected Richard III (on the Twitter-sphere, anyway) appreciates bioethics concerns. Read on to find out more about Richard III’s eagerness for patient confidentiality and other updates in this week’s (extended) Twitter round-up:

  • Stephen Latham (@StephenLatham) included a link to his blog post challenging Andrew Francis’ recent claim that penicillin was the central drug spawning the sexual revolution of the 1960s. While penicillin may have facilitated the widespread acceptance of pre-marital relations, it was The Pill that “translat[ed] that newfound sexual freedom into sexual equality.” (1/28)
  • Dan Vorhaus (@genomicslawyer) posted a summary video regarding the Neanderthal baby story that rocked the internet in the past few weeks, as reported by Taiwan’s Next Media animation. (1/28)
  • Michelle Meyer (@MichelleNMeyer) shared a news report on Israel’s recent admittance to giving birth control to Ethiopian Jewish immigrants, frequently without either consent or knowledge. Concerns first arose after an investigative journalist began to explore why birth rates in the community had fallen so drastically and seemingly inexplicably. (1/28)
  • Arthur Caplan (@ArthurCaplan) linked to a piece explaining the future implications and consequences of the guidance requiring schools to make “reasonable modifications” in order to include students with disabilities in either general athletic programs or provide them with parallel opportunities. The guidance, while a potential huge move forward for individuals with disabilities, nonetheless will be nothing without “tough and honest conversation about financing and revenue – and soon.” (1/28)
  • Michelle Meyer (@MichelleNMeyer) retweeted an article showing the return of the “invisible gorilla” from the 2010 book, but this time in the fake CT scans shown to both expert radiologists and volunteers alike. The gorilla was large in size compared to the typically indicative nodules, and was unmistakably a gorilla, but yet 20 out of the 24 radiologists failed to see the gorilla. It’s a frightening real-life example of what the original study’s jargon terms as “inattentional blindness.” (1/29)
  • Kevin Outterson (@koutterson) live tweeted the Pew meeting concerning new antibiotic development pathways for limited populations. See the string of tweets on his Twitter page for further details of how the meeting proceeded. (1/31)
  • Daniel Goldberg (@prof_goldberg) shared a link describing the first scientific evidence suggesting that doctors can “truly feel” their patients’ pain. The study, done by Harvard researchers, used brain scans to indicate activated regions of physicians’ brains during a simulated interaction with patients. (2/1)
  • Frank Pasquale (@FrankPasquale) linked to a story on the problems associated with over-prescribing amphetamine-based medications, particularly to teenagers and young adults. While focusing on the individual story of an aspiring medical student named Richard Fee, the author delves into the underexposed side effects of often overzealous prescribing and the surprisingly casual attitude that most Americans hold towards this medication. (2/3)
  • Frank Pasquale (@FrankPasquale) also posted a piece inspired by the talk surrounding World Cancer Day on the problems related to cancer treatment in developing countries. Contrary to being solely a problem of so-called developed nations, cancer remains an issue globally – including such cancers that are caused by an infectious agent. Fighting the false notions – that cancer in developing nations is minimal, that it is always not “catchable,” and that enough care (particularly vaccines) is being delivered – is essential to reducing the global inequity in cancer treatment. (2/4)
  • Michelle Meyer (@MichelleNMeyer) retweeted the (supposedly resurrected and technologically adept) Richard III’s tweet regarding publication of details surrounding his newly-identified bones: “Hmmm not so happy about my physical attributes being discussed in public. What happened to patient confidentiality ???” (2/4)
  • Daniel Goldberg (@prof_goldberg) shared a report on a new study that found a correlation between low self-esteem and female body representation and obsession in “chick lit.” The report noted that the results suggested a possible “intervention tool” by having characters seek support from friends and family for such body concerns. (2/5)
  • Michelle Meyer (@MichelleNMeyer) retweeted a graphic eloquently summarizing one of the simplest and most potent arguments in favor of vaccination, and arguably the greater biopharmaceutical industry. (2/6)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Maintenance of Effort in Maine

After the NFIB decision in June, Maine tried to expand Justice Roberts’ remedy to also make the “maintenance of effort” provision optional for states. Maine was unsuccessful in the First Circuit with the argument, for procedural reasons.  Prior coverage here.

The Obama Administration is sticking to the letter of the law, and announced Tuesday that it is refusing to allow cuts for Medicaid beneficiaries at or below 133% (138% after the 5% income disregard) of FPL in Maine.

Maine has not yet announced whether it will take the case back to the First Circuit. With Huberfeld & Leonard, we’ve argued at length (see esp. pp. 75-83) that Maine does not have the winning argument, in an article to be published in the BU Law Review later this month. SSRN version here. The short version is that MOE is a common tool to lock-in states during transition to a new program, was discussed in the briefing, but was not part of the coercion analysis in Justice Roberts’ plurality. The key provision was 42 USC 1396c, the Secretary’s authority to reduce some or all of the funding to non-compliant states. But we will see if Maine wants to argue the substance of this point at the First Circuit.

@koutterson