Diabetes Technology Moves Closer To Making Life Easier For Patients

NPR, October 18, 2017
by Miriam E. Tucker

[...] Both continuous glucose sensing and fast-acting insulin are critical components to the development of so-called "closed-loop" or artificial pancreas systems, which aim to automate insulin delivery… Read More

F.D.A. Approves Second Gene-Altering Treatment for Cancer

New York Times, October 18, 2017
by Denise Grady

The Food and Drug Administration on Wednesday approved the second in a radically new class of treatments that genetically reboot a patient’s own immune cells to kill cancer. The new therapy, Yescarta,… Read More

Innovative Contracting for Pharmaceuticals and Medicaid’s Best-Price Rule

Journal of Health Politics, Policy and Law, September 28, 2017
by Rachel E. Sachs (Academic Fellow Alumna), Nicholas Bagley, and Darius N. Lakdawalla

From the paper: In recent years, drug manufacturers and private payers have expressed interest in novel pricing models that more closely link a drug’s price to its value. Indication-based pricing,… Read More

Battle over drug prices shifts back to the states

The Hill, October 11, 2017
by By Rachel Roubein, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: President Trump has derided pharmaceutical companies as “getting away with murder,” but there’s been little action in Washington to rein in the costs of prescription… Read More

Congress keeps the heat on 340B

Politico, October 10, 2017
by By Sarah Karlin-Smith, citing work by Rachel E. Sachs (Academic Fellow Alumna)

From the article: The House Energy and Commerce Oversight Subcommittee will probe Wednesday into how hospitals and health clinics participating in the 340B discount drug program are using the… Read More

‘That should be illegal’

Business Insider, October 10, 2017
by By Lydia Ramsey, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Allergan, the drugmaker behind Botox, is using a tricky workaround to protect patents on one of its drugs — and lawmakers aren't exactly happy about it.  The deal, which… Read More

ICER Weekly View 10-06-17

ICER, October 6, 2017
by Mitchell Stein, featuring work by Rachel E. Sachs (Academic Fellow Alumna)

From the review: Medicaid’s “best price rule” has long been held up as an obstacle to value pricing – health policy/legal experts take a look and conclude that “the best-price… Read More

Axios Vitals post from October 4

Axios, October 4, 2017
by By Sam Baker, featuring work by Rachel E. Sachs (Academic Fellow Alumna)

From the post: Medicaid and value-based drug deals: New research casts some doubt on the pharmaceutical industry's claim that Medicaid's "best-price" rule inhibits its ability to create contracts… Read More

Letter to Allergan plc

The House of Representatives Committee on Oversight and Government Reform, October 3, 2017
by By Trey Gowdy, Elijah E. Cummings, Dennis A. Ross, and Peter Welch, citing blog post by Rachel E. Sachs (Academic Fellow Alumna)

From the letter: On September 8, 2017, your company announced the trans r of six patents related to its Restasis drug to the Saint Regis Mohawk tribe. 1 The unconventional maneuver has received considerable… Read More

Absent federal action, states take the lead on curbing drug costs

The Washington Post, September 29, 2017
by By Shefali Luthra, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Critics see these tailored efforts as falling short or potentially opening other loopholes. Requiring companies to report prices past a certain threshold, for example, might encourage… Read More

IBM to Congress

STAT, October 4, 2017
by Casey Ross and Ike Swetlitz

To the public, IBM trumpets its Watson supercomputer as the next big thing in medicine, a new kind of machine that melds human expertise with digital speed to give patients personalized… Read More

Hurricane Damage in Puerto Rico Leads to Fears of Drug Shortages Nationwide

New York Times, October 4, 2017
by Katie Thomas and Sheila Kaplan

Federal officials and major drugmakers are scrambling to prevent national shortages of critical drugs for treating cancer, diabetes and heart disease, as well as medical devices and supplies, that are… Read More

FDA’s Approval Of A Cheaper Drug For Hepatitis C Will Likely Expand Treatment

NPR, October 4, 2017
by Michelle Andrews

[...] The recent approval of a less expensive drug that generally cures hepatitis C in just eight weeks may make it easier for more insurers and correctional facilities to expand treatment. The… Read More

FDA Law SSRN Reading List - August 2017

Objective Intent Blog, September 14, 2017
by By Erika Lietzan, highlighting work by Rachel E. Sachs (Academic Fellow Alumna)

From the post:  Rachel Sachs, Administering Health Information (forthcoming in Cardozo Law Review).  Professor Sachs (Washington University, in St. Louis) explores the potential for… Read More

FDA Law SSRN Reading List - August 2017

Objective Intent Blog, September 14, 2017
by Erika Lietzan, highlighting work by Rachel E. Sachs (Academic Fellow Alumna)

From the post:  Rachel Sachs, Administering Health Information (forthcoming in Cardozo Law Review).  Professor Sachs (Washington University, in St. Louis) explores the potential for… Read More

How to Protect a Drug Patent? Sell it to a Native American Tribe

New York Times, September 8, 2017
by Katie Thomas

The drugmaker Allergan announced Friday that it had transferred its patents on a best-selling eye drug to the Saint Regis Mohawk Tribe in upstate New York — an unusual gambit to protect the drug… Read More

FDA Accuses EpiPen Maker of Failing to Investigate Malfunctions

New York Times, September 7, 2017
by Katie Thomas

The Food and Drug Administration this week accused the drugmaker Pfizerof failing to properly investigate reports of malfunctioning EpiPens, including incidents when patients died or became… Read More

Influence, integrity, and the FDA: An ethical framework

Science, Sep 1, 2017: Vol. 357, Issue 6354, pp. 876-877.
by Spencer Phillips Hey, I. Glenn Cohen (Faculty Director), Eli Y. Adashi, & Aaron S. Kesselheim

Summary: Among the core missions of the U.S. Food and Drug Administration (FDA) are protecting public health by assuring the safety and efficacy of drugs, biologics, and medical devices and advancing public… Read More

Obamacare survives its latest threat: Bare counties

POLITICO Pulse, August 21, 2017
by Dan Diamond, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Trump quietly signs FDA reauthorization bill. The president didn't hold a signing ceremony on Friday, even though the bill has been one of the few major pieces of legislation… Read More

Questions About The FDA’s New Framework For Digital Health

Health Affairs Blog, August 16, 2017
by Nathan G. Cortez, Nicolas Terry, and I. Glenn Cohen (Faculty Director)

From the article: In June 2017, the new Food and Drug Administration (FDA) commissioner Scott Gottlieb pre-announced his agency’s Digital Health Innovation Action Plan that indicates… Read More

The One Time Congress Let the Public Comment on an Upcoming Bill

Pacific Standard, August 14, 2017
by Francie Diep, quoting Rachel E. Sachs (Academic Fellow Alumna)

[...] Congress doesn't typically ask for public comments on the bills it's considering. But, in January of 2015, the House Energy and Commerce Committee did just that, for a first draft of the 21st… Read More

Administering Health Innovation

Cardozo Law Review, Forthcoming 2018
by Rachel E. Sachs (Academic Fellow Alumna)

Abstract Scholars and policymakers have recently begun to focus on the role federal agencies charged with health-related missions can play in the development of innovative health technologies and promotion… Read More

Who’s Actually Using ‘Right-To-Try’ Laws?

RAPS, August 4, 2017
by Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow alumna)

'The record with state-level right-to-try laws also suggests lackluster interest from industry. "It's telling that although 37 states have adopted these laws, when asked to provide examples of… Read More

Public Participation in Drafting of the 21st Century Cures Act

The Journal of Law, Medicine & Ethics, July 14, 2017
by Thomas J. Hwang, Rachel E. Sachs (Academic Fellow Alumna), Aaron S. Kesselheim

Abstract The 21st Century Cures Act is a major act of legislation that contains numerous changes to drug and device regulation. The House of Representatives passed the Act after considerable interest group… Read More

FDA to Speed Review of Generic Drug Applications Until It’s Approved Three of Them

STAT News, June 27, 2017
by Rebecca Robins, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: The Food and Drug Administration on Tuesday moved to try to spur more competition in the market for generic drugs, an effort aimed at driving down prices. In a policy change,… Read More

FDA User Fee Reauthorization Clears Hurdle In Senate With Bipartisan Support

Health Affairs Blog, May 15, 2017
by Rachel Sachs (Academic Fellow Alumna)

From the article: On Thursday, May 11, the Senate Committee on Health, Education, Labor and Pensions marked up the proposed Food and Drug Administration (FDA) user fee reauthorization bill and… Read More

Angel investors are the first stop in a new era of drug development

Newsworks, May 11, 2017
by Elana Gordon, quoting Rachel Sachs

From the article: So is this really the best way to develop new healthcare technologies and therapies? "So there are pros and there are cons," said Rachel Sachs, a law professor at Washington University in… Read More

The Trump administration could bring down drug prices. But it would take guts

STAT News, May 15, 2017
by Ed Silverman, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: “If Price and [President] Trump are interested in lower-priced drugs, they have access to a tool that enables them to do that,” explained Rachel Sachs, an associate professor… Read More

The White House budget director dropped a hint about how Trump could bring drug prices down

Washington Post, May 12, 2017
by Carolyn Y. Johnson, quoting Rachel Sachs (Academic Fellow Alumna)

From the artcile: Trump has repeatedly said that drug prices are too high but has often suggested that increased bidding would be the best way to bring down prices. It has been unclear how that… Read More

New FDA Chief Scott Gottlieb: Medication Reformer or Big Pharma Shill?

The Fix, May 18, 2017
by Paul Gaita, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Gottlieb's position has earned cautious approval from medical industry observers like Washington University associate professor Rachel Sachs, who wrote, "As someone who understands… Read More

New York state wants its prescription drug money back—or else

USA Today, May 18, 2017
by Julie Appleby, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: New York’s Medicaid program, for example, has seen its drug spending rise on average 8% each year over the past three years, after taking into account existing rebates. The… Read More

There’s a federal law to lower drug prices—and Louisiana may just use it

Ars Technica, May 4, 2017
by Beth Mole, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Rachel Sachs, a law professor at Washington University in St Louis, told the KHN that this makes a good argument for summoning 28 U.S.C. § 1498. “The case is strong,”… Read More

Louisiana proposes tapping a century-old patent law to cut hepatitis C drug prices

Kaiser Health News, May 2, 2017
by Sarah Jane Tribble, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Rachel Sachs, an associate professor of law at Washington University in St. Louis who attended the recent Johns Hopkins meeting, said she believes “the case is strong” in… Read More

Promoting demand-side innovation: prizes for payers

Journal of Law and the Biosciences, May 5, 2017
by Rachel E. Sachs (Academic Fellow Alumna)

From the paper: Promoting Healthcare Innovation on the Demand Side,1 the recent article by Professors Rebecca Eisenberg and Nicholson Price, is a thoughtful, detailed look at an issue that has gone… Read More

Value-Based Pricing For Pharmaceuticals In The Trump Administration

Health Affairs Blog, April 27, 2017
by Rachel E. Sachs (Academic Fellow Alumna), Nicholas Bagley, and Darius Lakdawalla

From the article: Everyone seems to agree: Drug prices are too damn high. Scandalous prices for new drugs and enormous price hikes on old drugs have focused public ire on the pharmaceutical… Read More

As a competitor encroached, Mylan took one state to court to push EpiPen sales, documents

STAT News, April 24, 2017
by Ike Swetlitz, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Three lawyers who reviewed the case at the request of STAT said they could not think of another instance when a pharmaceutical company sued to protect the status of its medication… Read More

Death By 1,000 Cuts: How Republicans Can Still Alter Your Coverage

Kaiser Health News, April 10, 2017
by Jay Hancock, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: “It’s the single-biggest problem facing the exchanges,” said Rachel Sachs, a health law professor at Washington University in St. Louis. “That would make insurers… Read More

Congress and FDA nominee heap love on ‘adaptive trials’

Science, April 7, 2017
by Kelly Servick, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: “‘Adaptive clinical trials’ is one of those buzzwords that get brought up all the time,” says Rachel Sachs, an innovation and health law professor at Washington… Read More

Scott Gottlieb: Conflicts surround Trump’s FDA pick

CNN, April 4, 2017
by Sandee LaMotte, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Even some industry watchdogs are cautiously optimistic. In a New England Journal of Medicine perspective, Rachel Sachs, a Washington University associate professor of law who studies… Read More

ICER Weekly View 03-31-17

ICER, March 31, 2017
by Mitchell Stein, featuring blog post and NEJM article co-authored by Rachel E. Sachs (Academic Fellow Alumna)

From the review: Democrats’ New Drug Bill Improving Access to Affordable Prescription Drugs Act was introduced this week.  You can read the summary of the bill here.  Rachel Sachs… Read More

Anthem inches closer to full Obamacare exit

POLITICO, March 31, 2017
by Dan Diamond, featuring blog post by Rachel E. Sachs (Academic Fellow Alumna)

From the newsletter: WHAT WE'RE READING Writing at Harvard’s “Bill of Health,” Rachel Sachs offers reasons to be bullish on Democrats’ drug price legislation but also picks… Read More

Senate will vote to overturn Planned Parenthood protections

POLITICO, March 30, 2017
by Dan Diamond, featuring NEJM article co-authored by Rachel E. Sachs (Academic Fellow Alumna)

From the newsletter: What the experts are saying. NEJM posted a pair of perspectives that offering dueling approaches to Gottlieb and the challenges he may face, if confirmed. — "An FDA Commissioner… Read More

Price doesn’t satisfy Congress on appropriations

POLITICO, March 30, 2017
by Darius Tahir, featuring NEJM article co-authored by Rachel E. Sachs (Academic Fellow Alumna)

From the newsletter: The latest issue of the New England Journal of Medicine is full of eHealth-relevant papers. Two articles consider Scott Gottlieb’s nomination for FDA commissioner. One,… Read More

Scott Gottlieb’s FDA Commissioner Confirmation Hearing: Remarkably Unremarkable

Health Affairs Blog, April 7, 2017
by Rachel E. Sachs (Academic Fellow Alumna)

From the post: On Wednesday morning, the United States Senate Committee on Health, Energy, Labor, and Pensions conducted the confirmation hearing for Dr. Scott Gottlieb, President Trump’s nominee… Read More

Release of New FDA Guidance Declines Sharply Following Trump’s Inauguration

Regulatory Affairs , April 11, 2017
by Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow Alumna)

[...] Rachel Sachs, an associate professor of law at Washington University in St. Louis, told Focus: “I think they're waiting for Gottlieb to set his priorities, and they'll move forward… Read More

(Health) Law and Order

Beyond the Microscope Podcast, March 28, 2017
by Mumu Xu, interviewing Rachel E. Sachs (Academic Fellow Alumna)

We’ve got a special episode today for all you STEM/legal nerds. Our guest is Rachel Sachs, an Associate Professor at the Washington University in St. Louis School of Law. Rachel works at… Read More

An FDA Commissioner for the 21st Century

NEJM, March 29, 2017
by 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… Read More

Regulating Black-Box Medicine

Michigan Law Review, March 21, 2017
by W. Nicholson Price II (Academic Fellow Alumnus)

From the abstract: Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms… Read More

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

Forbes, February 10, 2017
by 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… Read More

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

Regulatory Affairs Professionals Society (RAPS), February 6, 2017
by 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… Read More

E&C delays vote on drug pricing bill

Politico, February 6, 2017
by 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… Read More

What You Don’t Know About the Cost of Grandma’s Prescription

Pacific Standard, February 3, 2017
by Carson Leigh Brown, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: To grapple with how and why the process works this way, we talked with Rachel Sachs, an associate professor of law at Washington University in St. Louis. Sachs studies how health… Read More

Common Rule Revisions: Impact of Public Comment, and What’s Next?

The Hastings Center Blog, February 8, 2017
by By Holly Fernandez Lynch (Executive Director), I. Glenn Cohen (Faculty Director) and Barbara E. Bierer

From the blog post: On January 19, the day the final revisions to the Federal Policy for the Protection of Human Subjects were published in the Federal Register, our essay “Public Engagement,… Read More

What Experts in Law and Medicine Have to Say About the Cost of Drugs

The Health Care Blog, February 2, 2017
by Andy Oram, on PFC's 5th Annual Health Law Year in P/Review Conference

From the article; Pharmaceutical drug costs impinge heavily on consumers’ consciousness, often on a monthly basis, and have become such a stress on the public that they came up repeatedly among both… Read More

Trump’s travel ban rattles medical residency programs

Politico Pulse, January 31, 2017
by Dan Diamond, featuring blog post by Rachel Sachs (Academic Fellow alumna)

From the article: Trump's order on regulations is a 'terrible idea' for rulemaking. That's according to law professor Rachel Sachs, who uses the 21st Century Cures Act — which… Read More

Morning View 01-31-17

Institute for Clinical and Economic Review (ICER), January 31, 2017
by Mitchell Stein, featuring blog post by Rachel Sachs (Academic Fellow alumna)

From the article: The President issued an Executive Order basically saying that for every new regulation, two old regulations must be eliminated.  This order will have a significant impact on the… Read More

Vitals

Axios, January 31, 2017
by David Nather, featuring blog post by Rachel Sachs (Academic Fellow alumna)

From the article: The executive order could have an especially big impact on implementing the 21st Century Cures law, which just passed in the last Congress. Rachel Sachs, a health care legal expert at… Read More

The $4,500 injection to stop heroin overdoses

Washington Post, January 27, 2017
by Shefali Luthra, quoting W. Nicholson Price II (Academic Fellow Alumnus)

From the article: Thanks to an infusion of public funding to combat opioid overdoses, other institutional buyers may also be able to afford Evzios. Their budgets are larger right now, so they’re… Read More

Regulating Secrecy

Washington Law Review, 2016, Vol. 91, Nr. 4
by W. Nicholson Price II (Academic Fellow Alumnus)

Abstract: Inventors face a stark choice between two intellectual property systems of protecting innovative ideas: patents and trade secrecy. But accounts of this choice underexplore the role of the… Read More

Promoting healthcare innovation on the demand side

Journal of Law and the Biosciences, January 16, 2017 (online first)
by W. Nicholson Price II (Academic Fellow Alumnus) and Rebecca S. Eisenberg

Abstract: Innovation policy often focuses on fortifying the incentives of firms that develop and sell new products by offering them lucrative rights to exclude competitors from the market. Regulators also… Read More

Federal Circuit Court Appeal Cites Rachel E. Sachs

U.S. Court of Appeals for the Federal Circuit, January 13, 2017, No. 17-1480
by Paul D. Clement et al., citing work by Rachel E. Sachs (Academic Fellow Alumna)

No. 17-1480 UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT   AMGEN INC., AMGEN MANUFACTURING, LTD., and AMGEN USA, INC., Plaintiffs-Appellees, v. SANOFI, SANOFI-AVENTIS U.S. LLC, AVENTISUB… Read More

FDA Further Explains Delay on LDT Guidance

Regulatory Affairs Professionals Society, January 13, 2017
by Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Several praised the move to delay the final guidance, particularly as a new administration and Congress work with FDA and the Centers for Medicare & Medicaid Services (CMS) to… Read More

PFC Spotlight: Faculty Affiliate Ameet Sarpatwari

The Petrie-Flom Center, January 12, 2017

Ameet Sarpatwari, J.D., Ph.D., is an Instructor in Medicine at Harvard Medical School, an Associate Epidemiologist at Brigham and Women’s Hospital, and Assistant Director of the Program On Regulation,… Read More

The Oxford Handbook of U.S. Healthcare Law

The Oxford Handbooks, July 2016 (online), January 2017 (print)
by Edited by I. Glenn Cohen (Faculty Director), Allison K. Hoffman (Academic Fellow Alumna), and William M. Sage

Abstract: The Oxford Handbook of U.S. Health Law covers the breadth and depth of health law through the words and insights of the best scholars in the field. The content is valuable to readers with… Read More

The FDA Should Approve Drugs Based on Evidence, Not Emotions

Slate, December 13, 2016
by Alan Levinovitz, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Unlike many other countries, the United States managed to avoid the thalidomide crisis, thanks to a heroic FDA regulator named Frances Oldham Kelsey. Despite intense pressure from… Read More

Funding for Cures Bill Remains Sticking Point for Health Groups

Bloomberg, November 28, 2016
by Anna Edney and Zachary Tracer, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: The Cures bill will fund some prevention efforts, said Lynne Weil, a spokeswoman for Representative Diana DeGette, a Democrat from Colorado who helped shape the House’s original… Read More

Morning View 11-28-16: Pharmaceuticals News

Institute for Clinical and Economic Review's Morning View, November 28, 2016
by Mitchell Stein, citing Bill of Health post by Rachel E. Sachs (Academic Fellow Alumna)

From the article: On Friday, building on the long-standing DC tradition of releasing gargantuan regulations and bills over holiday weekends, the “final” text of the 21st Century Cures bill… Read More

House lines up biotech lollipops as support grows for an epic 21st Century Cures Act

Endpoints News, November 28, 2016
by James Carroll, citing Bill of Health blog post by Rachel E. Sachs (Academic Fellow Alumna)

From the article: According to Kaiser Health News, more than 1,400 lobbyists have taken a crack — for and against — various sections of this bill. And that helps explain why… Read More

Lame duck Congress looks for swift approval of massive medical innovation bill

AJC.com (The Atlanta Journal-Constitution), November 27, 2016
by Jamie Dupree, citing Tweet & Bill of Health post by Rachel E. Sachs (Academic Fellow Alumna)

From the article: (Tweet by Rachel E. Sachs) My 1st thoughts on today's draft of 21st Century Cures: some bad provisions are gone, some remain, & some to watch. http://blogs.harvard.edu/billofhealth/2016/11/25/the-newest-21st-century-cures-draft-moderates-but-doesnt-eliminate-controversy/ … Read More

Using Twitter as an Intelligence Tool: 85 Accounts Worth Following

Regulatory Affairs, November 16, 2017
by Zachary Brennan, citing Twitter accounts of Rachel E. Sachs (Academic Fellow Alumna), Ameet Sarpatwari, Aaron Kesselheim and Amitabh Chandra (Affilia

With the rise of president-elect Donald Trump, it’s become abundantly clear that Twitter matters. And it matters not just for politics. For regulatory affairs folks in in the pharmaceutical and medical… Read More

Regulating Off-Label Promotion — A Critical Test

NEJM, November 2, 2016
by Christopher Robertson, JD, PhD (Academic Fellow Alumnus) and Aaron S. Kesselheim, MD, JD, MPH (Faculty Affiliate)

Petrie-Flom Academic Alumnus Christopher T. Robertson and Faculty Affiliate Aaron S. Kesselheim have coauthored a new Perspective article in NEJM on recent judicial decisions regarding… Read More

Drug prices: Where do we go after the Election?

The Conversation US, October 30, 2016
by Rachel E. Sachs (Academic Fellow Alumna)

Martin Shkreli. Valeant Pharmaceuticals. Mylan. These names have become big news, but just a year ago, most Americans devoted little time and attention to the question of pharmaceutical pricing. Now, a… Read More

Drug Pricing: Where Do We Go After the Election?

Institute for Public Health, Washington University in St. Louis, October 26, 2016
by Rachel Sachs

From the blog post: Martin Shkreli. Valeant Pharmaceuticals. Mylan. Just a year ago, most Americans devoted little time and attention to the question of pharmaceutical pricing. Now, after a series of highly… Read More

The Readout: Speaking of Drug Prices

STAT, October 12, 2016
by Damian Garde and Meg Kesh, featuring Rachel Sachs (Academic Fellow alumna)

From the post: How? Washington University law professor Rachel Sachs and Department of Veterans Affairs economist Austin Frakt suggest tying drug prices to cost-effectiveness. They'd also like society… Read More

Innovation–Innovation Tradeoffs in Drug Pricing

Annals of Internal Medicine, October 11, 2016
by Rachel Sachs (Academic Fellow alumna)

From the article: The uproar over the price of the EpiPen is the latest episode in a longstanding controversy over drug pricing. A common concern is that proposed regulation of drug markets may reduce… Read More

Generic EpiPen Will Likely Secure Profits For Mylan

Law360, September 22, 2016
by Dani Kass, quoting Rachel Sachs (Academic Fellow alumna)

[...] Many customers are still likely to use the branded products once the generic is released, because copay discount cards and other assistance programs Mylan provides may make the branded drug… Read More

EBOLA and FDA: reviewing the response to the 2014 outbreak, to find lessons for the future

Journal of Law and the Biosciences, September 16, 2016
by Emily A. Largent (Student Fellow alumna)

Abstract: In 2014, West Africa confronted the most severe outbreak of Ebola virus disease (EVD) in history. At the onset of the outbreak—as now—there were no therapies approved by the U.S.… Read More

5 reasons why no one has built a better EpiPen

STAT, September 9, 2016
by Meghana Keshavan, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] But critics say Mylan has little incentive to improve EpiPens: “If you’re the monopolist, and you’ve got a product that expires every year, and it’s not super easy to… Read More

Euro Drug Pricing’s Tradeoffs May Limit Appeal In US

Law360, September 8, 2016
by Dani Kass, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] Going forward, an influx of bills targeting drug prices could be introduced, but few are likely to pass, according to Joshua P. Cohen, a researcher at the Tufts Center for the Study of Drug… Read More

EpiPen’s Dominance Driven By Competitors’ Stumbles And Tragic Deaths

NPR, September 7, 2016
by Pauline Bartolone, quoting W. Nicholson Price II (Academic Fellow alumnus)

NPR recently called on Petrie-Flom Academic Fellow alumnus Nicholson Price to help explain how Mylan's Epi-Pen has come to dominate the market for epinephrine autoinjectors. From the article: … Read More

Missouri law professor: Consider price controls after Epipen controversy

Missourinet, September 5, 2016
by Jason Taylor, quoting Rachel E. Sachs (Academic Fellow Alumna)

A Missouri law professor thinks Congress should consider imposing price controls on certain drugs after the EpiPen controversy. Mylan, the pharmaceutical company that provides the life saving pen… Read More

Mylan’s sudden plans for a generic EpiPen

Modern Healthcare, Vital Signs Blog, August 31, 2016
by Adam Rubenfire, quoting Rachel E. Sachs (Academic Fellow alumna)

From the post: Obviously Mylan didn't want to underprice its own branded drug, but it's possible they had filed away plans for a generic version in case a significant competitor arose. Rachel Sachs,… Read More

Mylan’s decision to make a cheaper, generic EpiPen ‘baffles’ experts

Business Insider, August 31, 2016
by Lydia Ramsey, featuring blog post by Rachel E. Sachs (Academic Fellow alumna)

From the article: "I and others who study these issues full time cannot understand why Mylan thought this would work to quell the widespread indignation over its pricing practices," Rachel Sachs,… Read More

The FDA Wants To Make It Harder To Buy And Sell Poop

BuzzFeed, August 13, 2016
by by Nidhi Subbaraman, quoting Rachel Sachs (Academic Fellow alumna)

[...] Depending on how the approval is handed down, Rebiotix could very well put outfits like OpenBiome out of business, Rachel Sachs, a health and law professor at the Washington University at St.… Read More

The FDA is prohibited from going germline

Science, August 5, 2016
by I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

Petrie-Flom Faculty Director I. Glenn Cohen has co-authored a new article in Science magazine addressing recent legislation preventing the FDA from approving any research "in which a human embryo… Read More

CALL FOR ABSTRACTS: 2017 Petrie-Flom Center Annual Conference
Harvard Law School

Deadline: Due no later than December 2, 2016

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2017 annual conference, entitled: “Transparency in Health and… Read More

This Could Have Been The First Poop Pill To Hit The Market, But It Failed Clinical Trials

BuzzFeed Science, July 29, 2016
by Nidhi Subbaraman, quoting Rachel Sachs (Academic Fellow alumna)

[...] “I think it is a big deal,” said Rachel Sachs, a professor of health and law at Washington University in St. Louis, who has researched how microbial therapies could be regulated… Read More

A Trojan Horse?

Ohio State Law Journal, 2017 (forthcoming)
by Christopher T. Robertson (Academic Fellow alumnus)

Abstract:       Scholars, advocates, and courts have begun to recognize a First Amendment right for drugmakers to promote their products “off-label”, without proving… Read More

Need For Blood In Orlando Raises Questions About Wisdom Of Banning Donors Due To Sexual Orientation

Forbes, June 14, 2016
by Rita Rubin, reviewing article by I. Glenn Cohen (Faculty Director), Jeremy Feigenbaum, and Eli Y. Adashi

Excerpt from the article: [...] In a 2014 “viewpoint” article in the Journal of the American Medical Association, two Harvard Law School professors and a Brown University physician said… Read More

FDA Regulations Limit Blood Donations From Gay Men

CBS San Francisco, June 14, 2016
by Holly Quan, featuring I. Glenn Cohen (Faculty Director)

Excerpt from the article: On World Blood Donation Day and in the wake of the Orlando mass shooting, a leading bioethicist Tuesday called for a change in the FDA’s policy regulating blood donations… Read More

After The Orlando Massacre, Many In The LGBTQ Community Are Turned Away From Giving Blood

Greater Boston (WGBH), June 14, 2016
by Nikki Blank, interviewing I. Glenn Cohen (Faculty Director)

Excerpt from interview: Early in the 1980's, there was a lifetime ban or deferral for any man who had ever had sex with another man. Even once. But in May, the FDA released new recommendations… Read More

Preventing Mitochondrial DNA Diseases: One Step Forward, Two Steps Back

Journal of the American Medical Association, June 9, 2016
by I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

From the article: On February 3, 2016, the Institute of Medicine (IOM) released its Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial… Read More

Call for Papers: Tenth Annual Symposium on Health Law and Policy
Beazley Institute for Health Law and Policy, Loyola University

Deadline: May 31, 2016

The Beazley Institute for Health Law and Policy at Loyola University Chicago School of Law and Annals of Health Law invite original research paper submissions on innovations in life sciences and stakeholder… Read More

FDA’s Punt on Finalizing the Generic Drug Labeling Rule: Experts Debate

Regulatory Affairs Professionals Society, May 19, 2016
by Zachary Brennan, featuring Rachel E. Sachs (Academic Fellow)

From the article:  Rachel Sachs, JD, an academic fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, also told Focus: “In my view,… Read More

Regulatory Specialist
Partners HealthCare

Deadline: June 05, 2016

As a not-for-profit organization, Partners HealthCare is committed to supporting patient care, research, teaching, and service to the community by leading innovation across our system. Founded by Brigham… Read More

Pediatrician for Pediatric Research Ethics
Office of Pediatric Therapeutics

Deadline: June 05, 2016

The Office of Pediatric Therapeutics (OPT), located in the FDA Office of the Commissioner, is seeking a pediatrician with experience in pediatric research ethics. OPT provides ethical expertise for… Read More

What’s next for opioid legislation?

Politico Pulse, April 22, 2016
by Dan Diamond, referencing Rachel E. Sachs (Academic Fellow)

Excerpt from article: [...] HEALTH WONK RECAP — PULSE flagged a few interesting studies and articles from the week that you may have missed. Using prescription drug insurance as an innovation… Read More

Prizing Insurance: Prescription Drug Insurance as Innovation Incentive,

Harvard Journal of Law and Technology, Vol. 30, No. 1 (forthcoming)
by Rachel E. Sachs

Abstract:  A problem perennially facing scholars of both intellectual property and health law is the need to incentivize appropriately the development of new pharmaceuticals. Although physicians have… Read More

Book Review: FDA in the Twenty-First Century:The Challenges of Regulating Drugs and New Technologies

Journal of Law and the Biosciences, Vol. 3, Issue 1 (April 1, 2016)
by Ryan Abbot, reviewing book edited by Holly Fernandez Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

From the review:  FDA in the 21st Century is an excellent edited volume based on the Petrie–Flom Center's 2013 Annual Conference. The conference sought to gather thought… Read More

Chinese Market Offers New Life to Many Drugs

Dow Jones Business News, March 29, 2016
by Fanfan Wang, quoting I. Glenn Cohen (Faculty Director)

Excerpt from Article: [...] But the new trend also raises the question of whether China has become a dumping ground for inferior drugs. I. Glenn Cohen, a Harvard Law School professor who studies medical… Read More

Feeling Better: What is the FDA doing, and how is it doing it?

The Weekly Standard, March 21, 2016
by Devorah Goldman, reviewing FDA in the 21st Century by Holly F. Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

Excerpt from the article: [...] In his last State of the Union address, Barack Obama asked, “How do we make technology work for us and not against us?" This was one of Obama's four "big… Read More

FDA - Food

U.S. Food and Drug Administration

Website for the U.S. Food and Drug Administration, one of the agencies responsible for regulating the safety of the U.S. food supply.  Read More

Title 21: Food and Drugs

Code of Federal Regulations

In Chapter I, Subchapter B, Parts 100-190, the regulations applicable to FDA’s oversight of food. Read More

FDA - Guidance and Regulation

U.S. Food and Drug Administration

Section of the FDA website containing FDA guidance and regulatory information applicable to food, including information about food safety programs, manufacturing processes, industry systems, and import/export… Read More

Planned Parenthood And Fetal Tissue Sale: Manufactured Controversy And The Real Ethical Debate

Health Affairs Blog, March 9, 2016
by I. Glenn Cohen (Faculty Director)

From the article: [...] Planned Parenthood received US $528 million of government money in 2014, much of it going to pay for services that include contraception and cancer screenings, which it… Read More

Food Code

U.S. Food and Drug Administration

The FDA’s Food Code is a model that assists food control jurisdictions at all levels of government by providing them with a technical and legal basis for regulating the retail and food service segment… Read More

USDA - Food Safety

U.S. Department of Agriculture, Food Safety and Inspection Service

Website for FSIS, an agency of the USDA responsible for ensuring food safety for meat, poultry, and egg products. Read More

Foodborne Outbreaks

Centers for Disease Control

This site outlines the CDC’s role in investigation, surveillance, and prevention of food safety outbreaks.  Read More

Food Safety

FoodSafety.gov

Describes provisions of the Food Safety Modernization Act of 2011 and their role in strengthening the food safety system.  Read More

Codex Alimentarius

World Health Organization

The Codex, administered by WHO and the U.N. Food and Agriculture Organization, establishes international food safety benchmarks to promote consumer safety.  Read More

Food Labeling Litigation

by Nicole E. Negowetti

Report on food labeling class action lawsuits and FDA regulatory authority.  Read More

Food and Drug Law Institute

Non-profit site providing a space for discussion of food and drug law, including conferences and publications.  Read More

Harvard Food Law and Policy Clinic

The Harvard Law School clinic focused on seeking to increase access to healthy foods, reduce food waste, and utilize law and policy to impact the food system. Read More

Fecal Transplants to Treat C. difficile: FDA Seeks Comment on What IND Requirements to Waive

Regulatory Affairs, February 29, 2016
by Zachary Brennan, citing Rachel E. Sachs (Academic Fellow)

From the article:  [...] The draft guidance comes as over the past few years, FMT, which basically involves the transfer of a healthy donor stool to the bowel of a patient infected with C. difficile,… Read More

Food Safety News

Website providing coverage on food safety issues, including contributions from the FDA. Read More

A Tool to Help Address Key Ethical Issues in Research

Journal of Medical Ethics Blog, February 22, 2016
by Rebecca H. Li & Holly Fernandez Lynch (Executive Director)

From the article:  One of the most important responsibilities of a clinical project lead at a biotech company or an academic research team is to generate clinical trial protocols. The protocol dictates… Read More

The Unpatentable Microbiome

New England Regional Junior Faculty Scholarship Workshop, February 12, 2016
by Rachel E. Sachs (Academic Fellow)

Presentation Abstract:  Scientists have recently begun to appreciate the important role played by the human microbiome, the community of microbes that live within each of our bodies and outnumber… Read More

Academic Fellow Rachel E. Sachs to Join Faculty at Washington University School of Law

Petrie-Flom Center, February 17, 2016

We are pleased to announce that Petrie-Flom Center Academic Fellow Rachel E. Sachs has been appointed an Associate Professor at the Washington University in St. Louis School of Law.  At Washington… Read More

Food and Drug Law

Peter Hutt et al., 2013

Introductory casebook on administrative and other key issues in food and drug law.  Read More

Expert Committee: FDA Should Allow Mitochondrial Replacement Trials Under Certain Conditions

Regulatory Affairs, February 3, 2016
by Zachary Brennan, quoting I. Glenn Cohen (Faculty Director)

From the article: Glenn Cohen, faculty director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School, wrote on the center’s blog Wednesday:… Read More

“FDA in the 21st Century: A Panel Discussion”

MAGI, May 2, 2016, 8:30 - 10:00 AM
by Holly Fernandez Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

On Monday, May 2, 2016, from 8:30 to 10:00am, Petrie-Flom Executive Director Holly Fernandez Lynch and Faculty Director I. Glenn Cohen will participate in a plenary session at the 2016 MAGI Clinical Research… Read More

Why Preventing Cancer Is Not the Priority in Drug Development

The Upshot, New York Times, December 28, 2015
by Austin Frakt, citing Ben Roin (former Academic Fellow and Faculty Co-Director)

From the article:  Most people would agree that it would be better to prevent cancer, if we could, than to treat it once it developed. Yet economic incentives encourage researchers to focus on… Read More

FDA Says Gay Men Can Give Blood — But Only If They Don’t Have Sex for a Year

VICE News, December 22, 2015
by VICE News Staff, quoting I. Glenn Cohen (Faculty Director)

From the article: [...] Harvard Law School bioethics and the law professor I. Glenn Cohen told VICE News last year that while he thought the FDA's policy change is a good first step, it does not… Read More

FDA eases blood donation ban on gay men

CBS News, December 21, 2015
by Interview with I. Glenn Cohen (Faculty Director)

The FDA is easing its restrictions on gay and bisexual men who want to make a blood donation. But there's a catch -- the lifetime ban is being replaced with a new policy that requires gay and bisexual… Read More

FDA’s Pathway for Regulation of Fecal Microbiota Transplants

Journal of Law and the Biosciences, October 26, 2015
by Margaret F. Riley and Bernat Olle, in response to Rachel Sachs (Academic Fellow)

From the article:  [...] A recent article by Rachel Sachs and Carolyn Edelstein inthe Journal of Law and the Biosciences on regulation of fecal microbiota transplants (FMT) brought a welcome… Read More

Blood Illuminated: Panel Discussion of FDA Blood Ban From Gay and Bisexual Men

YouTube Video of Event at Katzen Arts Center, American University, October 6, 2015
by I. Glenn Cohen (Faculty Director)

From a description of the event on Out Magazine: Dating back to a policy enacted during the height of the AIDS crisis, for three decades men who have sex with men (MSM) have been banned from giving blood… Read More

Innovations in Health Law and Policy: Regulatory Challenges and Strategies for Change Conference

UNH School of Law, October 26, 2015
by W. Nicholson Price II (Academic Fellow Alumnus)

Innovations in Health Law and Policy: Regulatory Challenges and Strategies for Change When: Monday, October 26, 2015 Where: UNH School of Law 2 White Street Concord, New Hampshire Presented by the Health… Read More

How Patent Law Can Block Even Lifesaving Drugs

New York Times, September 28, 2015
by Austin Frakt, quoting Benjamin Roin (Former Faculty Co-Director & Academic Fellow; Current Affiliated Faculty)

From the article: To see evidence of this, just look at the behavior of pharmaceutical firms. When Benjamin Roin, assistant professor of technological innovation, entrepreneurship, and strategic management… Read More

How Prescription Drugs Get So Wildly Expensive

WIRED, September 23, 2015
by Nick Stockton, quoting Rachel E. Sachs (Academic Fellow)

From the article: [...] With all that in mind, here’s the important question: Is Shkreli an industry outlier, or was he just unlucky enough to be found out? “There’s one aspect… Read More

FDA in the 21st Century

Columbia University Press, September 2015
by Holly Fernandez Lynch (Executive Director) and I. Glenn Cohen (Faculty Director), eds.

Just out from Columbia University Press, FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies! This volume, co-edited by Petrie-Flom Center Executive… Read More

Review of Innovation Law and Policy: Preserving the Future of Personalized Medicine

Written Description Blog, July 27, 2015
by Lisa Ouellette

From the review: I highly recommend two recently posted articles on declining innovation incentives for diagnostic tests, particularly due to changes in patentable subject matter doctrine. In Innovation… Read More

Research, Regulation, and Ethics: Discussion of Human Subjects Research Regulation Book

Science for the People Podcast, July 2015, No. 327
by Desiree Schell

About the podcast: This week we're learning about the regulatory frameworks that try to balance scientific progress with the safety of research subjects. We'll speak to Holly Fernandez Lynch and… Read More

Review of Human Subjects Research Regulation: Perspectives on the Future

IRB: Ethics & Human Research, July-August 2015, Vol. 37, No. 4
by Christine Grady

Christine Grady, MSN, PhD, the chief of the Department of Bioethics in the Clinical Center of the National Institutes of Health, recently published a review of Faculty Director I. Glenn Cohen &… Read More

Will clinical trial data disclosure reduce incentives to develop new uses of drugs?

Nature Biotechnology, July 2015, Vol. 33, No. 7
by W Nicholson Price II (Academic Fellow alumnus) & Timo Minssen (past Visiting Scholar)

Petrie-Flom Academic Fellow alumnus Nicholson Price, now an Assistant Professor at the University of New Hampshire School of Law, and past Visiting Scholar Timo Minnsen, Associate… Read More

PAPER NOW AVAILABLE

Journal of Law & the Biosciences, July 6, 2015 (Published Online)
by Rachel Sachs (Academic Fellow) and Carolyn Edelstein

Academic Fellow Rachel E. Sachs has a new article on the regulatory challenges of fecal microbiota transplantation in the Journal of Law & the Biosciences:  Abstract:… Read More

Countdown to Cures

The Medicine Maker, June 25th, 2015, Issue #0615
by Stephanie Sutton, quoting Rachel Sachs (Academic Fellow)

From the article:  [...] According to Rachel Sachs, an academic fellow at the Petrie-Flom Center at Harvard Law School who has been following the Act with interest, 21st Century Cures has the potential… Read More

Food Law and Policy Clinical Fellow
Harvard Food Law and Policy Clinic

Deadline: July 16, 2015

The Harvard Food Law and Policy Clinic, a division of the Center for Health Law and Policy Innovation of Harvard Law School, is seeking a Clinical Fellow (35181BR) to start in summer or early fall… Read More

New Review of Academic Fellow Rachel Sachs on Fecal Transplants

The Incidental Economist, June 1, 2015
by Nicholas Bagley

Rachel E. Sachs' new paper "Ensuring the Safe and Effective FDA Regulation of Fecal Microbiota Transplantation," coauthored with Carolyn Edelstein, has been reviewed by Nicholas Bagley on The… Read More

Faculty Director I. Glenn Cohen: New Blood-Donor Policy, Same Gay Stigma

New York Times, May 21, 2015
by I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

Faculty Director I. Glenn Cohen has co-authored an op-ed for the New York Times on the FDA's new blood donor policy. From the piece: LAST week, the Food and Drug Administration released highly… Read More

Innovation Law and Policy

U. C. Davis Law Review, Forthcoming 2016
by Rachel E. Sachs

Academic Fellow Rachel E. Sachs has a new article forthcoming in 2016 on law and the future of personalized medicine. From the article: Personalized medicine is the future of health care, and as such incentives… Read More

“Ending Institutional Corruption” conference, May 1-2

Edmond J. Safra Center for Ethics at Harvard University, April 14, 2015

On Friday, May 1, and Saturday, May 2, several Petrie-Flom Center affiliates will participate in the Edmond J. Safra Center for Ethics at Harvard University conference "Ending Institutional Corruption." Participants… Read More

Are trade secrets delaying biosimilars?

Science, April 10, 2015
by W. Nicholson Price II (Academic Fellow Alumnus) and Arti K. Rai

Petrie-Flom Academic Fellow alumnus Nicholson Price, now an Assistant Professor at the University of New Hampshire School of Law, has recently published an article in Science on the cost and… Read More

Transatlantic Lessons in Regulation of Mitochondrial Replacement Therapy

Science, April 10, 2015
by I. Glenn Cohen (Faculty Director), with Eli Adashi and Julian Savulescu

Cambridge, Mass., April 9, 2015 – A paper forthcoming on Friday in Science discusses the regulation of a new technology that gives hope to women who carry genetic disease. Mutant mitochondrial DNA… Read More

Trio contrast approaches taken by Britain versus the US concerning mitochondrial replacement therapy

MedicalXpress, April 10, 2015
by Bob Yirka, citing I. Glenn Cohen (Faculty Director) et al.

Glenn Cohen, with Harvard University, Julian Savulescu, with the University of Oxford and Eli Adashi with Brown University have together written and published a Perspectives piece in the journal Science,… Read More

Is UK evaluation of reproductive tech a model for US?

MedicalXpress, April 10, 2015
by David Orenstein, citing I. Glenn Cohen (Faculty Director) et al.

When the United Kingdom resoundingly approved mitochondrial replacement therapy in February, it became the first country to give people this new medical option. In parallel it gave the United… Read More

Academic Fellow Rachel Sachs Presents at 2015 Works-in-Progress in Intellectual Property Colloquium

Petrie-Flom Center, February 7, 2015

Petrie-Flom Academic Fellow Rachel Sachs presented her paper, "Innovation Law and Policy: Preserving the Future of Personalized Medicine," at the 2015 Works-in-Progress in Intellectual Property (WIPIP)… Read More

Third Annual Health Law Year in P/Review collaborative blogging with Health Affairs

Petrie-Flom, February 5, 2015

The Third Annual Health Law Year in P/Review was a big success!  Video will be posted on our website shortly, but our presenters will be posting on their respective topics in a collaborative blog… Read More

Research Project Grant Funding Opportunity
National Institutes of Health (NIH)

Deadline: January 19, 2015

Funding Opportunity Title: Empirical Research on Ethical Issues Related to Central IRBs and Consent for Research Using Clinical Records and Data (R01) Activity Code: R01 Research Project Grant Announcement… Read More

First biosimilar drug set to enter US market

Nature, January 13, 2015
by Heidi Ledford, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] The FDA is expected to make a final decision by May. But even as Sandoz prepares to sell its drug in the United States, it is embroiled in a patent fight with Amgen. By US law, Sandoz had to reveal… Read More

FDA plans to end prohibition on blood donation by gay men, with conditions

PBS News Hour, December 23, 2014
by Gwen Ifill, interviewing I. Glenn Cohen (Faculty Director)

"[...] the ban that we had in place was really outdated. It dates back to 1983, the early days of the HIV crisis, and a few things have changed since then. First of all our ability to test and test quickly… Read More

F.D.A. Easing Ban on Gays, to Let Some Give Blood

New York Times, December 23, 2014
by Sabrina Tavernise, quoting I. Glenn Cohen (Faculty Director)

[...] “This is a major victory for gay civil rights,” said I. Glenn Cohen, a law professor at Harvard who specializes in bioethics and health. “We’re leaving behind the old view… Read More

FDA Announces Plans to End Lifetime Ban on Gay Men Donating Blood

Vice News, December 23, 2014
by Colleen Curry, quoting I. Glenn Cohen (Faculty Director)

[...] Harvard Law School bioethics and the law professor I. Glenn Cohen told VICE News that while he thought the FDA's proposed policy change is a good first step, it does not go far enough. According… Read More

US lifts ban on gay men donating blood — as long as they don’t have sex with other men

Vox, December 23, 2014
by Sarah Kliff and Julia Belluz, quoting I. Glenn Cohen (Faculty Director)

[...] Glenn Cohen, a Harvard Law professor who wrote about the blood donor rule in JAMA: the Journal of the American Medical Association, sees a one-year deferral as an interim step, but thinks it's… Read More

Bioethics Funding Opportunity: Making a Difference in Real-World Bioethics Dilemmas
The Greenwall Foundation

Deadline: January 12, 2015

New Bioethics Program, Spring 2015 Making a Difference in Real-World Bioethics Dilemmas The Greenwall Foundation will fund a bioethics grants program, Making a Difference in Real-World Bioethics Dilemmas to… Read More

FDA Advisors Not Sold on Lifting Ban on Gay Men Giving Blood

Philly.com, December 3, 2014
by Dennis Thomson, quoting I. Glenn Cohen (Faculty Director)

[...] The FDA first adopted the policy at the dawn of the AIDS crisis. However, changing times and technological advances have rendered the decades-old ban obsolete, according to Glenn Cohen, who directs… Read More

Decades-old ban on blood donations from gay men to be revisited

MSNBC, December 1, 2014
by Andrea Mitchell interviewing I. Glenn Cohen (Faculty Director)

Petrie-Flom Faculty Director I. Glenn Cohen, who co-wrote the argument against the ban on gay male blood donation in the Journal of the American Medical Association, joins NBC's Andrea Mitchell… Read More

Will FDA Lift Gay Blood Donor Ban?

NewsMax Health, December 1, 2014
by Quoting I. Glenn Cohen (Faculty Director)

[...] "They really are out of step with the rest of the world," Glenn Cohen, a Harvard Law School professor, told the Post. In a recent article in the Journal of the American Medical Association,… Read More

US FDA to Consider Lifting Ban on Gay Men Donating Blood

International Business Times, November 30, 2014
by Hannah Osborne, quoting I. Glenn Cohen (Faculty Director)

[...] Speaking of the forthcoming discussion, Glenn Cohen, a medical ethics professor at Harvard Law School, said: "It's a little crazy that you can shed blood for your country, but you can't… Read More

Government could ease 31-year-old ban on blood donations from gay men

Washington Post, November 29, 2014
by Brady Dennis, quoting I. Glenn Cohen (Faculty Director)

[...] “They really are out of step with the rest of the world,” said Glenn Cohen, a Harvard Law School professor who with two colleagues recently argued in the Journal of the American Medical… Read More

FDA weighs lifting ban on blood donations from gay men

The Hill, November 28, 2014
by Sarah Ferris, quoting I. Glenn Cohen (Faculty Director)

[...] “The public health rationale for this ban has kind of been packed away,” said Glenn Cohen, a medical ethics professor at Harvard Law School who criticized the ban in an article recently… Read More

The Changing Regulation of Laboratory-Developed Tests

Genomic Medicine Case Conference (GMCC) at Massachusetts General Hospital, November 14, 2014
by Rachel Sachs (Academic Fellow)

On November 14, 2014, Academic Fellow Rachel Sachs delivered a talk on the topic of the FDA’s intent to regulate LDTs following the draft guidelines that will be published in the coming… Read More

​Nudging the FDA

The American Interest, October 17, 2014
by W. Nicholson Price II (Academic Fellow alumnus) and I. Glenn Cohen (Faculty Director)

From the article: [...] The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients and the… Read More

Newsmax Panel: Experimental Ebola Drugs Have Run Out

Newsmax TV, October 6, 2014
by America's Forum, interviewing I. Glenn Cohen (Faculty Director)

From the article: [...] The Liberian man diagnosed with Ebola in Dallas is not receiving an experimental drug because there is a dearth of supply, according to Harvard law professor and medical ethicist… Read More

FDA Proposal for Regulating Laboratory Diagnostics Could Improve Patient Care

Hastings Center Bioethics Forum, September 4, 2014
by Rachel Sachs (Academic Fellow)

From the article: [...] [T]he FDA's proposal [to regulate laboratory-developed tests] ... could improve patient care by collecting, for the first time, clinical validity data on tens of thousands of… Read More

Teen suicide victim’s eyes were rejected by FDA as donor organs because he was gay

Mail Online, August 15, 2014
by Mail Online Reporter, quoting I. Glenn Cohen (Faculty Director)

From the article: The FDA has blocked the donation of a teen suicide victim's eyes because he was gay, it has emerged. Alexander 'A.J.', Betts Jr., 16, of Pleasant Hills, Iowa, committed… Read More

After suicide, gay teen’s eye donation rejected

Washington Post, August 14, 2014
by Ryan Weber, quoting I. Glenn Cohen (Faculty Director)

From the article: In the Journal of the American Medical Association, Glenn Cohen, a bioethics law professor at the Harvard Law School, wrote that the United States should repeal the rules about blood.… Read More

Ethical issues over experimental Ebola drug

CCTV America, August 13, 2014
by Asieh Namdar, interviewing I. Glenn Cohen (Faculty Director)

Faculty Director I. Glenn Cohen appeared on CCTV America to discuss ethical questions about who is receiving an experimental drug to treat Ebola. From the interview: [...] Usually when… Read More

Experts urge lifting ban on blood donations by gay men

CBS News, July 25, 2014
by Dennis Thompson , quoting I. Glenn Cohen (Faculty Director)

The United States should repeal a 30-year policy that bans blood donations from gay and bisexual men, according to a team of medical and legal experts writing this week in the Journal of the American Medical… Read More

FDA Regulation of Mobile Health Technologies

NEJM, July 24, 2014
by Nathan G. Cortez, J.D., I. Glenn Cohen, J.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H.

Petrie-Flom Faculty Director I. Glenn Cohen has published a new co-authored article in the New England Journal of Medicine on FDA regulation of new mobile health technologies. From the article: Medicine… Read More

Reconsideration of the Lifetime Ban on Blood Donation by Men Who Have Sex With Men

JAMA, July 23, 2014
by I. Glenn Cohen, JD (Faculty Director); Jeremy Feigenbaum, JD; Eli Y. Adashi, MD, MS

Faculty Director I. Glenn Cohen has co-authored a new Viewpoint piece in the July 23/30, 2014 issue of JAMA, arguing for the end of the FDA's lifetime ban on blood donation by men who have sex with… Read More

Call for Submissions: Journal of Law and the Biosciences

Deadline: August 29, 2014

Journal of Law and the Biosciences (JLB) is actively soliciting original manuscripts, responses, essays, and book reviews devoted to the examination of issues related to the intersection of law and… Read More

Call for Abstracts: Emerging Issues and New Frontiers for FDA Regulation
Washington, DC

Deadline: June 03, 2014

      The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative… Read More

Welcome 2014-2016 Academic Fellow Rachel Sachs!

Petrie-Flom Center, April 17, 2014

The Petrie-Flom Center is pleased to announce the new 2014-2016 Academic Fellow, Rachel Sachs. Rachel earned her J.D. in 2013 magna cum laude from Harvard Law School, where she was… Read More

FDA Advises Against Morcellator Use in Hysterectomies

Wall Street Journal, April 17, 2014
by Jon Kamp and Jennifer Levitz, quoting I. Glenn Cohen (Faculty Director)

[...] "The fact that the FDA released this warning makes it more likely that a doctor who went against it will be held to have practiced in a way below the standard of care," said I. Glenn Cohen,… Read More