An FDA Commissioner for the 21st Century

NEJM, March 29, 2017
Amitabh Chandra and Rachel E. Sachs (Academic Fellow Alumna)

President Donald Trump has named Scott Gottlieb as his nominee to be the next commissioner of the Food and Drug Administration (FDA). As compared with some of the other people whose names were floated publicly for the position, Gottlieb is a traditional choice, a physician who served in a deputy commissioner…

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Sanofi, Regeneron ask court to shield Dupixent from Amgen patent attack

FiercePharma, March 21, 2017
Tracy Staton, citing blog post by Rachel E. Sachs (Academic Fellow Alumna)

From the article: [...]Amgen has caught fire for its aggressive stance on its PCSK9 patents, which also protect its own drug in the class, Repatha. Market watchers note that a similar patent fight—Merck & Co.'s hepatitis C lawsuit against Gilead Sciences—ended…

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In Pausing Human Research On Zika, Medical Ethicists Acknowledge A Dark Past

WBUR, March 21, 2017
Paul C. McLean, quoting Holly Fernandez Lynch (Executive Director)

From the article: That’s why ethics review of human subject research matters. This NIH panel is an especially good model in both its composition — expertise in law, medicine, medical science, social sciences, vaccine research and advocacy and bioethics…

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Addressing the ethical issues raised by synthetic human entities with embryo-like features

eLife, March 21, 2017
John Aach, Jeantine Lunshof, Eswar Iyer, and George M. Church

On November 7, 2016, the Petrie-Flom Center hosted the conference "The Ethics of Early Embryo Research & the Future of the 14-Day Rule," which convened experts in bioethics,…

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The ethics of recruiting study participants on social media

Medical Xpress , March 16, 2017
Heather Zeiger, citing Luka Gelinas (Fellow in Clinical Research Ethics)

From the article:  In the recent issue of the American Journal of Bioethics, the target article addresses the ethics of finding participants for clinical trials on social media sites. The authors, from Harvard Law School and Harvard Medical School, analyzed the particular…

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Harvard Law School Ranked #5 for Health Care Law

U.S. News & World Report , March 2017

U.S. News & World Report has released their rankings of the top law schools in the country. Harvard Law School, ranked #3 overall, was also ranked #5 in the country for health care law!

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NFL doctors are on the wrong team

Washington Post, March 11, 2017
Editorial Board, citing Football Players Health Study

From the article: So why did only 47 of 100 players who were surveyed by the Associated Press say they thought the league’s clubs, coaches and team doctors have the athletes’ best interests at heart? Even more damning were the results of a two-year…

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NFL’s medical structure puts profits before players’ health. That must change.

Washington Post, March 9, 2017
Sally Jenkins, citing Football Players Health Study

From the article: Just last month, a Harvard study concluded that “the intersection of club doctors’ dual obligations creates significant…

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The Original Lie About Obamacare

New York Times, March 14, 2017
David Leonhardt, quoting Michael Anne Kyle (Student Fellow Alumna)

From the article: At that point, Obama faced a second choice – between forging ahead with a substantively bipartisan bill and forgetting about covering the uninsured. The kumbaya plan for which pundits now wax nostalgic was not an option.

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Podcast: NFL Player Health with Chris Deubert

Sports Law Biz Blog, March 6, 2017
Peter Ott, interviewing Christopher R. Deubert (Senior Law & Ethics Associate)

From the blog: In this episode, Peter speaks with Chris Deubert, a Senior Law and Ethics Associate for the Law and Ethics initiative of the Football Players Health Study at Harvard University. Chris has wide ranging sports law experience and combined…

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Teen Behind Landmark Juvenile Decision Back Before Judge to Be Resentenced

Juvenile Justice Information Exchange, March 13, 2017
Matt Smith, quoting Robert Kinscherff (Senior Fellow in Law and Neuroscience)

From the article: “The result of this developmental process means that adolescents will not think like or process like adults will until probably their mid-20s,” said Robert Kinscherff, a forensic scientist and attorney at the Project on Law…

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Modern Death

MoMA R&D Salon, Salon 19, January 23, 2017
Frances Kamm (Senior Fellow Alumna)

The term modern has been central to MoMA’s identity since its founding, yet to be modern holds many connotations. To name just a few interpretations—not all canonical—modern can be understood as a static historical and aesthetic marker of the 20th century; a frenetic socio-cultural…

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Maryland Goes a Step Further to Rein in Drug Price Spikes

Regulatory Affairs Professionals Society (RAPS), February 27, 2017
Zachary Brennan, citing Rachel E. Sachs (Academic Fellow Alumna)

[...] The bill has drawn criticism from industry groups and others who say such independent audits would be overly burdensome for industry and that the $2500 threshold might include too many drugs as other states have included a $10,000 threshold, though other…

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Ethical Considerations for Zika Virus Human Challenge Trials: Report & Recommendations

National Institute of Allergy and Infectious Diseases (NIAID) at NIH and the Walter Reed Army Institute of Research (WRAIR), February 2017
Seema K. Shah, Jonathan Kimmelman, Anne Drapkin Lyerly, Holly Fernandez Lynch (Executive Director), et al.

From the report: Zika virus is an emerging infectious disease that was first identified in 1947, and that has more recently become a major public health threat around the world. Zika virus has recently been shown to cause devastating neurological damage in infants…

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Lawmakers urge US Army not to issue exclusive license to Sanofi for a Zika vaccine

Stat, February 22, 2017
Ed Silverman, quoting Rachel E. Sachs (Academic Fellow Alumna)

This article is behind a paywall.

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Express Scripts CEO addresses drug pricing ‘misinformation’

St. Louis Post-Dispatch, February 17, 2017
Samantha Liss, quoting Rachel E. Sachs (Academic Fellow Alumna)

[...] Typically, after dispensing drugs to patients, a drug manufacturer will write Express Scripts a rebate check. That timing can expose some patients, especially those with high deductibles, to the full cost of a drug, said Rachel Sachs, an associate professor of law at Washington University.…

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Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations

The American Journal of Bioethics, Volume 17, 2017 - Issue 3
Luke Gelinas, Robin Pierce, Sabune Winkler, I. Glenn Cohen, Holly Fernandez Lynch, and Barbara Bierer

Part of the Petrie-Flom Center's collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical…

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Why Did That Drug Price Increase 6,000%? It’s The Law

Forbes, February 10, 2017
Matthew Herper, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Marathon is a member of the Pharmaceutical Research and Manufacturers of America (PhRMA), the drug industry trade group. Drug companies cannot use their usual argument of saying this is an “outlier.” This is one of their own – although…

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Trump’s ‘Two Out, One In’ Regulatory Policy May Apply to Some FDA Guidance

Regulatory Affairs Professionals Society (RAPS), February 6, 2017
Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: As far as what existing regulations if repealed would be considered part of the “two out” part of the EO, OMB notes, “Any existing regulatory action that imposes costs and the repeal or revision of which will produce verifiable…

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E&C delays vote on drug pricing bill

Politico, February 6, 2017
Sarah Karlin-Smith, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: On cost: studies have found that it usually takes a handful of generic drugscompeting for market share for prices to drop. “You usually need to get to something like three or four generics to really make a difference,” said Rachel Sachs…

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