NEW EVENT (2/18): Assessing the Viability of FDA’s Biosimilar Pathway

16.02.18, FDA Biosimilars Pathway posterNEW EVENT: Assessing the Viability of FDA’s Biosimilar Pathway
February 18, 2016 12:00 PM
Pound Hall, Room 100
Harvard Law School
1536 Massachusetts Ave., Cambridge, MA

Description

The 2010 passage of the Biologics Price Competition and Innovation Act was intended to create a pathway for the approval of biosimilar drugs, to bring to market less expensive versions of innovators’ biologic therapeutics in the same way the Hatch-Waxman Act has worked so well for FDA approval of generic small-molecule drugs. But the Act has been mired in a host of statutory, regulatory, and scientific complication and delays, and five years later, the FDA has approved just one biosimilar product.  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

NEXT WEEK (2/10) Fetal Pain: An Update on the Science and Legal Implications

fetalpain_slideFetal Pain: An Update on the Science and Legal Implications
February 10, 2016 12:00 PM
Wasserstein Hall, Milstein East C
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Amanda Pustilnik, JD and Maureen Strafford MD will discuss fetal pain, including advances in neuroscience and treatment and their implications for the law. Continue reading

REGISTER NOW! (3/29) The Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration

PFC 10th Logo-Horizontal-Otlns-FnlThe Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration
March 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Petrie-Flom Center is celebrating its first decade and kicking off the next by looking at the future of health law and policy!

Please join us as we bring together Petrie-Flom and other prominent Harvard Law School alumni to discuss major trends, developments, and open questions in the fields of health law policy, biotechnology, and bioethics. We’ll hear about the founder’s vision for the Center and the Dean’s perspective on the Center’s influence within the Harvard Law School community and beyond. Center Leadership will discuss what we have accomplished in the first ten years, and more important, our plans for the future. Alan Weil JD ’89, Editor-in-Chief of Health Affairs, will deliver the keynote address.

Agenda

Continue reading

TOMORROW, 1/29! Fourth Annual Health Law Year in P/Review Symposium


MORE SEATS AVAILABLE! Fourth Annual Health Law Year in P/Review
January 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein West AB 
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Fourth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2015 and what to watch out for in 2016. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

In addition to presenting at the conference, many of our speakers will write about their topics for a collaborative blog series that will begin in February 2016 on the Health Affairs Blog.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the New England Journal of MedicineHealth Affairs, the Hastings CenterHarvard Health Publications at Harvard Medical School, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

Agenda Continue reading

Latest News from the Petrie-Flom Center!

Check out the January 22nd edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:


UPDATED AGENDA: Fourth Annual Health Law Year in P/Review
January 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East C 
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Fourth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2015 and what to watch out for in 2016. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

In addition to presenting at the conference, many of our speakers will write about their topics for a collaborative blog series that will begin in February 2016 on the Health Affairs Blog.

Continue reading

Four Key Issues In Health Law That Are As Relevant As Ever In 2016

Petrie-Flom’s Executive Director Holly Fernandez Lynch has a new post over at the Health Affairs Blog as the first entry in a series that will stem from our Fourth Annual Health Law Year in P/Review conference, to be held at Harvard Law School on Friday, January 29, 2016.

In it, Holly takes stock of which major issues in health law policy remain outstanding from years past, and which are coming down the pike, including:

  • The ACA (and the contraceptives coverage mandate, in particular)
  • The state of health care reform generally
  • Efforts to control health care costs
  • Emerging regulatory pathways to speed patient access to new products
  • And more…

Read the full post here.

TOMORROW, 1/20! A Conversation with Margaret A. Hamburg, FDA Commissioner 2009-2015

A Conversation with Margaret A. Hamburg, FDA Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), speaks during an interview in Washington, D.C., U.S., on Wednesday, May 28, 2014. A new program that lets drugmakers move more quickly through the approval process for breakthrough products may help lower the cost of life-saving treatments, Hamburg, the nation's chief drug regulator, said today. Photographer: Andrew Harrer/Bloomberg via Getty ImagesCommissioner 2009-2015
January 20, 2016 12:30 PM
Wasserstein Hall, Milstein East ABC (2nd floor)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the Petrie-Flom Center for a conversation with former FDA Commissioner (and former New York City Health Commissioner), Dr. Margaret A. Hamburg, led by Peter Barton Hutt, former Chief Counsel to FDA and current Senior Counsel at Covington & Burling LLP and Lecturer on Law at HLS. Topics discussed will include FDA’s role and the changing scientific, legal, political, and economic landscape; the overlap of science, innovation, and cost regarding biomedical products; food safety and nutrition; challenges of globalization, and more.

Speakers:

  • Margaret A. Hamburg, Commissioner of the U. S. Food and Drug Administration, 2009-2015
  • Peter Barton Hutt, Covington & Burling and Harvard Law School

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.

Thought about Breastfeeding and Civil Liberties

Breastfeeding is known for being an extremely politicized issue. Past decades introduced us to different interest groups advocating for and against the ideal of “Breast is best”. A recent book by Courtney Jung called ‘Lactivism: How Feminists and Fundamentalists, Hippies and Yuppies, and Physicians and Politicians Made Breastfeeding Big Business and Bad Policy’ describes how the ideal of breastfeeding became a focal point of consensus among conflicting political groups like environmentalists and capitalists, leftists and conservatives and many more. The book reveals troubling regulatory schemes which sanction non-breastfeeding moms by denying benefits and iron rich food for their babies. This pattern of body governance echoes Dorothy Roberts’ book ‘Killing the Black Body’ which described how procreation decisions made by poor-black-women, are constantly sanctioned and regulated by the state in order to achieve social objectives, for example, by conditioning welfare benefits in an installation of permanent contraceptives.

In Roberts’ book, a clear distinction is made with respect to the reproductive liberty of black and white women. The contraceptive pill, which symbolizes the emblem of reproductive freedom and is highly identified with the feminist movement, was the product of a scientific endeavor greatly motivated by conservative groups’ desire to control population through family planning schemes, historically targeting the fertility of poor black women. In a similar way, the ideal of “breast is best” has also been operating differently with respect to race and economic status. In Linda Blum’s bookAt the Breast: Ideologies of Breastfeeding and Motherhood in Contemporary United States’ she conducts interviews with women who didn’t nurse. She found that in contrast to white women who strove for outer respectability and experienced their lack of breastfeeding as a failure to conform with the breastfeeding imperative, black women emphasized their use in feeding instruments as significant for their independence which was highly evaluated. Accordingly, statistics show generally lower breastfeeding rates among black women in the US.

Continue reading

The Right to Health, the Affordable Care Act, and Non-Treaty Treaties (Part II)

Special guest post by Nicholas J. Diamond

In Part I, I argued that the Affordable Care Act (ACA), while a monumental step toward improving health care in the U.S., does not fully advance the right to health in a few key respects. Responding to shortcomings in the ability of the ACA to fully advance the right is, in my view, a matter of coalescing domestic health policymaking around the right to health.

Full advancement of the right to health in the U.S. requires a normative commitment to the content of the right as articulated in General Comment 14 and related instruments. This commitment requires internalization of human rights-based norms in domestic health policymaking. Such a commitment would not only encourage the consensus required to design appropriate domestic health policies, but also provide valuable guiding principles to shepherd implementation.

Given the current political climate around the ACA, coupled with an ongoing Presidential election, statutory amendment of the ACA in order to more fully advance the right to health is highly unlikely. What is more, reliance on the rulemaking process to advance the right to health, absent an appropriate statutory foundation, would be misplaced because agency rulemaking authority is itself a statutory construct.

In the alternative, ratification of the International Covenant on Economic, Social and Cultural Rights (ICESCR) could provide just such a commitment. The U.S. is, however, very unlikely to ratify the ICESCR as an Article II treaty. Historically, the U.S. has been reluctant to commit to international human rights instruments and the current Administration has expressed its intention not to pursue ratification (at least as an Article II treaty). Absent ratification, through which international norms are internalized in national policies, it remains unlikely that the right to health becomes a guiding norm in U.S. health policymaking. Continue reading

The Right to Health, the Affordable Care Act, and Non-Treaty Treaties (Part I)

Special guest post by Nicholas J. Diamond

The right to health has played a significant role in global health fora since the World Health Organization first identified the “enjoyment of the highest attainable standard of health” as a “fundamental right of every human being without distinction of race, religion, political belief, economic or social condition” in 1946. Twenty years later, the International Covenant on Economic, Social and Cultural Rights (ICESCR) would set out the right to health in a binding international instrument. Subsequent guidance in 2000 from the United Nations Committee on Economic, Social and Cultural Rights, referred to as General Comment 14, clarified the content of the right to health, as well as articulated four elements—availability, accessibility, acceptability, and quality—that constitute the right.

Despite widespread support in the international community, the U.S. has not ratified the ICESCR. Many have argued that the Affordable Care Act (ACA) is doubtless a significant step toward realization of the right to health in the U.S. Indeed, its design speaks directly, to varying degrees, to each of the four elements of the right to health. While I acknowledge the significance of the ACA in advancing the right to health in the U.S., there are at least three reasons to doubt its ability to fully advance the right. Continue reading

Some Commentary on How to Think About Secondary Research with Biospecimens

The public comment period on the NPRM to revise the Common Rule has just closed, and now we wait to see what happens (if anything), and when.  One of the most controversial proposals in the NPRM would require at least broad consent for secondary research with biospecimens (i.e., research on specimens originally collected for another purpose, either clinical care or a different study), regardless of whether those specimens retain identifiers.  This is a substantial change from the status quo, which does not require consent for such research with de-identified specimens.  How should we feel about this status quo, and the proposed change?  My own view is that it’s really not so bad: the risks to individual research participants are quite low, and the current approach facilitates critically important scientific advancement.  There is certainly room for improvement, e.g., to impose punishment on those who would act to re-identify de-identified specimens without permission, to inform the public that such research takes place, and to educate them about its value, perhaps allowing those who still feel very strongly that they prefer not to be included an opportunity to opt-out.  But what has been actually proposed has more problems than what it would replace, and in fact, wouldn’t solve some of those it seems to be a response to.

Rebecca Skloot feels otherwise.  She is the author of a book called The Immortal Life of Henrietta Lacks, which chronicles the origin of one particularly important cell line – HeLa  – derived from cells that had been excised from Ms. Lacks in the course of a 1951 surgery to treat her cancer, and later used for research without her knowledge or permission.  Ms. Lacks was poor, uneducated, and black, and her descendants have also faced more than their fair share of adversity.  Ms. Skloot paints a compelling story of exploitation, but in my opinion, it is much more effective as a narrative about the horrible and enduring legacy of racism in this country than as proof that researchers who conduct secondary research with biospecimens without consent (as permitted under the current regulations, remember) or even without profit-sharing have behaved badly. After all, if individual risks are low and social benefits high – both true – then what’s the problem?  And it is far from clear that specimen sources deserve compensation for no other reason than that their discarded material actually proves valuable to scientists.  Nonetheless, the book has been used as a rallying cry by people from all walks of life who believe that they should be allowed to control whether, and potentially how, their specimens are used for research. Indeed, The Immortal Life of Henrietta Lacks is probably the single most important development that pushed the proposed revisions to the Common Rule forward, for the first time since they were released in 1991.

Continue reading

The Impact of Genetic Testing on Children: What do we know, what’s missing?

Wakefield_Pic
By: Claire E. Wakefield, Lucy V. Hanlon, Katherine M. Tucker, Andrea F. Patenaude, Christina Signorelli, Jordana K. McLoone and Richard J. Cohn

Genetics research often pushes the boundaries of science, and by the far-reaching nature of genetic information, pushes us out of our comfort zones to consider new psychosocial, ethical, and legal scenarios. Conducting genetic testing on children arguably pushes our boundaries most. Yet, there can be medical benefits for some children, who may then be offered tailored medical care to match their risks. Children can also be indirectly affected by genetic testing, when they learn genetic information about themselves because a family member has had a genetic test. Continue reading

UPDATED AGENDA: Fourth Annual Health Law Year in P/Review, January 29!


UPDATED AGENDA: Fourth Annual Health Law Year in P/Review
January 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East C 
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Fourth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2015 and what to watch out for in 2016. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

In addition to presenting at the conference, many of our speakers will write about their topics for a collaborative blog series that will begin in February 2016 on the Health Affairs Blog.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the New England Journal of MedicineHealth Affairs, the Hastings CenterHarvard Health Publications at Harvard Medical School, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

Agenda Continue reading

1/20/16: Register Now! A Conversation with Margaret Hamburg, FDA Commissioner 2009-2015

A Conversation with Margaret A. Hamburg, FDA Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), speaks during an interview in Washington, D.C., U.S., on Wednesday, May 28, 2014. A new program that lets drugmakers move more quickly through the approval process for breakthrough products may help lower the cost of life-saving treatments, Hamburg, the nation's chief drug regulator, said today. Photographer: Andrew Harrer/Bloomberg via Getty ImagesCommissioner 2009-2015
January 20, 2016 12:30 PM
Wasserstein Hall, Milstein East ABC (2nd floor)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the Petrie-Flom Center for a conversation with former FDA Commissioner (and former New York City Health Commissioner), Dr. Margaret A. Hamburg, led by Peter Barton Hutt, former Chief Counsel to FDA and current Senior Counsel at Covington & Burling LLP and Lecturer on Law at HLS. Topics discussed will include FDA’s role and the changing scientific, legal, political, and economic landscape; the overlap of science, innovation, and cost regarding biomedical products; food safety and nutrition; challenges of globalization, and more.

Speakers:

  • Margaret A. Hamburg, Commissioner of the U. S. Food and Drug Administration, 2009-2015
  • Peter Barton Hutt, Covington & Burling and Harvard Law School

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.

Juvenile crime is down and high school graduation is up: Good news or distraction?

By Robert Kinscherff

At first glance it seems like unequivocal good news: Juvenile crime rates are at approximately the same levels as the early 1970’s and high school graduation rates have risen from 65 percent four years ago to 82 percent in 2013-2014.  But, a closer look suggests a different picture under the surface of this aggregate national data.

Overall rates of juvenile crime have diminished considerably since the high-water mark in the late 1980’s and early 1990’s but “hot spots” of violent crime by juveniles and young adults—especially gun violence—persistently burn in neighborhoods of large cities like Detroit, Chicago, Oakland, Cleveland, and Baltimore as well as in smaller cities like Flint (MI), New Haven (CT), Rockford (IL), Odessa (TX), and Springfield (MA), and in many rural areas with intractable high poverty rates and which have seen gang infiltration in recent years. Continue reading