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

Blinding as a Solution to Bias

Blinding Bias

We’re pleased to announce that a new book by Petrie-Flom Center affiliates Christopher Robertson and Aaron Kesselheim will be available this week.  The edited volume — Blinding as a Solution to Bias: Strengthening Biomedical Science, Forensic Science, and Law — grew from a 2013 conference at Harvard co-sponsored by the Petrie-Flom Center.  From the fascinating history of blinding (starting in Ben Franklin’s living room to test the healing powers of Mesmerism) to the sham surgeries being used today, and the future novel uses of blinding in the courts, the book moves the debate forward.  What are the advantages and limitations of blinding compared to other solutions for biases? How can we quantify the biases in unblinded research? Can we develop new ways to blind decision-makers?  What are the ethical problems with withholding information?  Fundamentally, questions about who needs to know what open new doors of inquiry for the design of scientific research studies, regulatory institutions, and courts.  With a foreword by Larry Lessig, the book surveys the theory, practice, and future of blinding, drawing upon leading authors with a diverse range of methodologies and areas of expertise, including medicine, law, forensic sciences, philosophy, economics, psychology, sociology, and statistics.  It is available for pre-order from the publisher and Amazon.com.

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

EEOC Tries to Harmonize ACA’s Promotion of Employer Wellness Programs with GINA’s Ban Against Employer Access to Genetic Information of Employees and Employees’ Family Members

[Cross-posted from the Genomics Law Report blog]

By

Gina-name-tagThe Equal Employment Opportunity Commission (EEOC) is responsible for enforcing Title II of the Genetic Information Nondiscrimination Act (GINA), which prohibits employers from requesting genetic information (defined broadly) from their prospective, current, or former employees. GINA contains only six limited exceptions to this prohibition, one of which is an exception for wellness programs in which the employee’s participation is voluntary.

On October 30, 2015 the EEOC issued a proposed ruleto amend GINA regulations in an attempt to harmonize them with the Affordable Care Act’s promotion of employer wellness programs to lower health care costs. The proposed rule tries to clarify that employers are permitted to offer incentives for an employee’s spouse to participate in a voluntary wellness program (but not the employee’s other dependents). The permissible incentives are capped at 30% of the total cost of the plan in which the employee and dependents are enrolled. The EEOC’s expressed intent is to treat GINA’s Title I (health insurance) and Title II (employment) provisions similarly. The proposed rule would allow employers to request current and former health status information from an employee’s spouse as part of their participation in the employer-sponsored wellness program. And there’s the rub: the current or former health status of an employee’s spouse is the employee’s own “genetic information” as the term is statutorily defined in GINA. The EEOC has prepared a Q&A page to explain the proposed rule, and the Congressional Research Service issued a report (R44311) on the topic on December 17, 2015. 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.

The Common Rule NPRM Blog Series: Posting of Consent Forms

By: Academic and Clinical Research Group at Verrill Dana LLP

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

The 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”), proposes a new provision that would require a copy of the final version of the consent form (absent any signatures) for each clinical trial conducted or supported by a Common Rule department or agency to be posted (within 60 days after the trial is closed for recruitment) on a publically available federal website that would be established for such purpose.

In Part 3 of our Academic and Clinical Research Group (“ACRG”) blog series on the Common Rule NPRM, we address the rationale behind this proposal and its potential benefits, downsides, and missed opportunities. Continue reading

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.

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

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.

Bioethicist Art Caplan – About Time: FDA Overturns Ban On Gay Men Donating Blood

A new piece by Bill of Health contributor Art Caplan on Forbes:

In 2001 one of my goals as the chair of the Federal government’s Advisory Committee on Blood Safety and Availability was to get the ban on gay men donating blood overturned. The ban made no sense ethically or scientifically. The ban stigmatized gay men, and insisting on a lifetime prohibition for even one sexual encounter, condom or no condom, made no scientific sense. Finally, almost 15 years later, the FDA has joined the rest of the Western world and dropped the lifetime prohibition.

The FDA still insists on a one-year ban on having sex with another man even though today’s testing is very reliable for detecting HIV and other diseases at six months. Still, at a time when blood donations are falling and demand is rising, getting more donors into the supply side is a very good thing. […]

Read the full article here.