Trump official on defensive as critics scoff at drug plan

The Hill , May 19, 2018
by Peter Sullivan, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: President Trump's health chief is struggling to show that the administration is serious about taking on drug companies after its proposals for lowering prices last week left big companies… Read More

Growing resistance to antifungal drugs ‘a global issue’

BBC News, May 18, 2018

Scientists are warning that levels of resistance to treatments for fungal infections are growing, which could lead to more outbreaks of disease. Intensive-care and transplant patients and those with cancer… Read More

Vermont Legislators Pass A Drug Importation Law. So What?

Kaiser Health News , May 18, 2018
by Shefali Luthra, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: This week, Vermont passed a first-in-the-nation law that would facilitate the state’s importation of prescription drugs wholesale from Canada. It represents the state’s… Read More

Trump spoke on lowering drug prices. The tweets rolled in

Stat, May 11, 2018
by Andrew Joseph, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Given that President Trump is famous for his Earth-shaking tweets, it seems appropriate to comb through Twitter reactions to his administration’s new drug pricing plan, which… Read More

ICER Weekly View 05-18-18

Institute For Clinical and Economic Review, May 18, 2018
by Mitchell Stein, citing Rachel Sachs (Academic Fellow Alumna)

From the article: Weekly View favorite (and Midwest CEPAC member) Rachel Sachs reviews the specific proposals in the speech in this Health Affairs blog. Trump’s Drug Pricing Speech Breaks Little… Read More

FDA website to post names of drug makers blocking development of cheaper generics

Marketplace, May 17, 2018
by Dan Gorenstein, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: The FDA plans to unveil a website today naming pharmaceutical companies that have blocked the development of generic drugs by failing to provide samples to competitors. This public posting… Read More

HHS Secretary Clarifies Trump Administration’s Plan To Reduce Prescription Drug Prices

NPR, May 17, 2018
by Alison Kodjak

[...] KELLY: First start just by reminding us what this proposal is. The president came out and made an announcement about drug prices last Friday in the Rose Garden. What exactly did he say? KODJAK:… Read More

F.D.A. Names and Shames Drug Makers to Encourage Generic Competition

New York Times, May 17, 2018
by Sheila Kaplan

Pharmaceutical companies that spend billions of dollars to develop new drugs do not want competitors to profit from inexpensive generic copies of blockbuster medicines. To avoid rivals, they fight for… Read More

Trump’s Drug Pricing Speech Breaks Little New Ground, Largely Spares Industry

Health Affairs Blog, May 14, 2018
by Rachel Sachs (Academic Fellow Alumna)

From the article: On Friday, President Donald Trump delivered a highly anticipated speech about drug pricing. The speech, coupled with the release of a “blueprint” providing more detail on… Read More

Trump promises to ‘derail the gravy train’ and lower drug prices in ‘American Patients First’ plan

The Washington Post , May 11, 2018
by Carolyn Y. Johnson, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  President Trump promised to “derail the gravy train” in the health-care system Friday afternoon, in a Rose Garden speech in which he unveiled his much-anticipated strategy… Read More

The 6 most interesting parts of Trump’s mostly disappointing drug price plan

Vox, May 11, 2018
by Dylan Scott, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  “We’re gonna see those prices go down. It’ll be a beautiful thing to watch,” President Donald Trump said in the Rose Garden on Friday. It’s a big promise.… Read More

How to Make a Dent in Crazy-High Drug Prices

Bloomberg, May 11, 2018
by By Austin Frakt, citing Rachel Sachs (Academic Fellow Alumna)

From the article: There’s no good reason to pay a lot for prescription drugs that don’t work well. But that’s what lots of Americans are doing. Some drug prices far outweigh any reasonable… Read More

Postdoctoral position in Biomedical Innovation Law with a focus on Biologics
Collaborative Research Program in Biomedical Innovation Law (CeBIL)

Deadline: May 22, 2018 11:59 GMT

The Faculty of Law (Faculty), University of Copenhagen, is seeking applications for position as postdoc. The position is part of the research project CeBIL and is for a duration of 3 (three) years. Start… Read More

Drug made famous by Shkreli’s 5,000% price hike is still $750 a pill

Ars Technica, May 4, 2018
by Beth Mole, quoting W. Nicholson Price II (Academic Fellow Alumnus)

From the article: Disgraced ex-pharmaceutical executive and hedge fund manager Martin Shkreli is now behind bars, facing a seven-year prison sentence for securities fraud. Yet the drug-price hike… Read More

For Shame: ‘Pharma Bro’ Shkreli Is In Prison, But Daraprim’s Price Is Still High

Washington Post, May 4, 2018
by Shefali Luthra, quoting W. Nicholson Price II (Academic Fellow Alumnus)

From the article: The continued high price of the drug is a cautionary tale to those who hope that public shaming of a few “bad actors” can curb escalating drug prices, because the problem… Read More

Trump is set to unveil his plan to lower drug prices. Here are four things to watch for.

The Washington Post, May 10, 2018
by Carolyn Y. Johnson, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: President Trump will deliver Friday afternoon a twice-delayed, much-anticipated speech about his plan to lower drug prices — after a year when harsh rhetoric against drugmakers was… Read More

As Opioid Liability Rises, Accreditor Seeks Credential For Pharma’s Educators

Forbes, May 9, 2018
by Bruce Japsen

As the U.S. grapples with the deadly opioid epidemic and public outrage over drug costs, an accreditor of medical affairs professionals and pharmaceutical sales representatives is grabbing the attention… Read More

Walmart Will Implement New Opioid Prescription Limits By End Of Summer

NPR, May 8, 2018
by Vanessa Romo

Walmart announced Monday it is introducing new restrictions on how it will fill opioid medication prescriptions in all of its in-store and Sam's Club pharmacies. It is the company's latest… Read More

What your government can’t tell you about drug prices

CBC News, May 3, 2018
by Kelly Crowe, Suit brought by Jean-Christophe Belisle Pipon (Visiting Researcher)

From the article: It took three years of fighting for access to confidential drug information, but a Quebec bioethicist has punched a tiny hole in the iron wall of secrecy surrounding patented drug prices.… Read More

How A Drug Company Under Pressure For High Prices Ratchets Up Political Activity

Kaiser Health News, April 30, 2018
by Jay Hancock and Elizabeth Lucas

Business looked challenging for Novo Nordisk at the end of 2016. As pressure mounted over the pharma giant’s soaring insulin prices, investors drove its stock down by a third on fears that policymakers… Read More

Vaccine against Meningitis

La Presse, April 25, 2018
by Marie-Claude Malboeuf, Suit brought by Jean-Christophe Belisle Pipon (Visiting Researcher)

From the article: Quebec has agreed to pay twice as much as the United Kingdom for a new vaccine against meningitis, the effectiveness of which seemed uncertain. The disclosure of the price paid by Quebec… Read More

Supreme Court rules that patent reviews detested by pharma are constitutional

STAT, April 24, 2018
by Ed Silverman, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: In a blow to the pharmaceutical industry, the U.S. Supreme Court ruled that a controversial procedure for reviewing patent disputes does not violate the constitutional rights of patent… Read More

Federal Appeals Court Finds State’s Drug Price-Gouging Law Unconstitutional

Shots: Health News From NPR, April 17, 2018
by Shefali Luthra, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: States are continuing to do battle with budget-busting prices of prescription drugs. But a recent federal court decision could limit the tools available to them — underscoring the… Read More

The breakthrough therapy designation for promising cancer drugs is good for patients

STAT, April 27, 2018
by Jeff Allen, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: One exciting component of the Food and Drug Administration Safety and Innovation Act was the creation of the breakthrough therapy designation. It allows an all-hands-on-deck… Read More

The $3 Million Research Breakdown

ProPublica, April 26, 2018
by Jodi S. Cohen

This story was co-published with The Chronicle of Higher Education. For nearly two decades, the University of Illinois at Chicago has touted child psychiatrist Mani Pavuluri as one of its stars: She founded… Read More

Giving Antibiotics To Healthy Kids In Poor Countries

NPR, April 25, 2018
by Susan Brink

Every day, 15,000 children five years old or younger die of preventable conditions diarrhea and pneumonia. In 2016, that number added up to 5.6 million children, most of them in the developing world, according… Read More

Assessing the FDA’s Breakthrough Drug Program After Six Years

ASH Clinical News, April 25, 2018
by ASH Clinical News, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: In the first four years of the U.S. Food and Drug Administration’s (FDA) breakthrough-therapy designation program, the agency approved 31 “breakthrough” drugs, but many… Read More

Efficacy, Safety, and Regulatory Approval of Food and Drug Administration–Designated Breakthrough an

Journal of Clinical Oncology , April 24, 2018
by Thomas J. Hwang, Jessica M. Franklin, Julie C. Lauffenburger, Bishal Gyawali, Aaron S. Kesselheim, and Jonathan J. Darrow (Student Fellow Alumnus)

From the article: The breakthrough therapy program was established in 2012 to expedite the development and review of new medicines. We evaluated the times to approval, efficacy, and safety of breakthrough-designated… Read More

The FDA Breakthrough-Drug Designation — Four Years of Experience

The New England Journal of Medicine, April 12, 2018
by Jonathan J. Darrow (Student Fellow Alumnus), Jerry Avorn, and Aaron S. Kesselheim,

This article is behind a paywall. Harvard affiliates can access the full text via Hollis +. From the article: In 2012, Congress created the “breakthrough therapy” designation to expedite Food… Read More

As Opioid Prescriptions Fall, Prescriptions for Drugs to Treat Addiction Rise

New York Times, April 19, 2018
by Abby Goodnough

WASHINGTON — The number of new monthly prescriptions for medications that treat opioid addiction nearly doubled over the past two years, according to new data, while prescriptions for opioid… Read More

Move over right-to-try: FDA looks at improving clinical trial enrollment

Politico, April 16, 2018
by Sarah Karlin-Smith, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: The FDA’s bar for “breakthrough” designation may be too low, Harvard Medical School policy researchers argue in the New England Journal of Medicine. The designation… Read More

Anguished Families Shoulder The Biggest Burdens Of Opioid Addiction

NPR, April 18, 2018
by Yuki Noguchi

[...] Johnson, 27, lay in a coma, silent except for the beeping of machines. She looked small and pale, buried in a tangle of hospital bedsheets and tubes, after suffering a dozen or so strokes as a result… Read More

Federal Appeals Court Puts Chill On Maryland Law To Fight Drug Price-Gouging

Kaiser Health News, April 17, 2018
by Shefali Luthra

States continue to battle budget-busting prices of prescription drugs. But a federal court decision could limit the weapons available to them — underscoring the challenge states face as they, in… Read More

News That Amazon Is Shelving Plans To Sell Drugs To Hospitals Sends Distributors’ Stock Soaring

Kaiser Health News, April 17, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations “This is not necessarily an all-clear event for the supply chain,” said Eric Coldwell, an analyst… Read More

Is the ‘Breakthrough Therapy’ Process Putting Dangerous Drugs on Store Shelves?

Healthline, April 17, 2018
by Shawn Radcliffe, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: A CNN report last week detailed the deaths of more than 700 patients prescribed an antipsychotic therapy drug for Parkinson’s disease. The Food and Drug Administration… Read More

Drug Test Spurs Frank Talk Between Hypertension Patients And Doctors

NPR, April 16, 2018
by Blake Farmer

[...] Research shows roughly half of patients don't take their high blood pressure medicine as they should, even though heart disease is the leading cause of death in America. For… Read More

Is FDA breakthrough therapy really valuable?

Genet, April 13, 2018
by Liu Xuan Tong, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: In the recent New England Journal of Medicine, articles published by Harvard University's Jonathan Darrow, Jerry Avorn, and Aaron Kesselheim point out many of the issues arising from… Read More

Objective Intent: SSRN Reading List February and March

Objective Intent, April 13, 2018
by Erika Lietzan, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: In this careful and thorough article forthcoming in the Minnesota Law Review, Professor Sachs argues that drug pricing concerns could be addressed in part if insurers were not required… Read More

The Clinical Trial Is Open. The Elderly Need Not Apply.

New York Times, April 13, 2018
by Paula Span

[...] Geriatricians have complained for years that figuring out treatments for their patients becomes dramatically more difficult when older people are excluded from clinical trials and other… Read More

When ‘Breakthrough’ Drugs Aren’t Actually Breakthroughs: FDA’s Approval Pathway Can Be Misleading

Kaiser Health News, April 12, 2018
by KHN Morning Briefing, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: In a review of three years of drugs approved by the Food and Drug Administration under a “breakthrough therapy” pathway, researchers argue that some of the compounds are not… Read More

Does the FDA’s ‘breakthrough’ drug program need to be reformed? Harvard skeptics say yes

Endpoint News, April 12, 2018
by John Carroll, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: Of all the expedited review programs that the FDA has set up, none are as popular as the “breakthrough” therapy designation. And a group of high-profile skeptics says that… Read More

Why Scott Gottlieb is the one Trump official everybody seems to like

Vox, April 11, 2018
by Julia Belluz, German Lopez, and Dylan Scott , quoting Rachel Sachs (Academic Fellow Alumna)

From the article: When Scott Gottlieb was appointed commissioner of the Food and Drug Administration last May, some were concerned he’d be a shill for the pharmaceutical industry.… Read More

House Democrat wants to know why a pharma insider is overseeing Trump’s drug pricing reform

Vox, April 9, 2018
by Dylan Scott, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: House Democrats want to know why the Trump administration is letting a former pharmaceutical industry insider oversee its plans to fulfill President Donald Trump’s promises to bring… Read More

Politico Pulse April 6, 2018

Politico, April 6, 2018
by Dan Diamond, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: In Health Affairs, Nick Bagley and Rachel Sachs ask why Massachusetts' proposal to ostensibly lower drug prices is getting a cold shoulder from the Trump administration. Read the… Read More

ICER Weekly View April 6, 2018

Institute For Clinical And Economic Review, April 6, 2018
by Mitchell Stein, quoting Rachel Sachs(Academic Fellow Alumna)

From the article: To the shock of patient advocates, MA wanted to institute a drug formulary for Medicaid. Reports this week indicate that CMS is poised to deny the waiver request. Law Professors Nicholas… Read More

Massachusetts Wants To Drive Down Medicaid Drug Costs: Why Is The Administration So Nervous?

Health Affairs, April 5, 2018
by Nicholas Bagley, and Rachel Sachs (Academic Fellow Alumna)

From the article: Although drug formularies are ubiquitous in Medicare and the private insurance market, they’re absent in Medicaid. By law, state Medicaid programs that offer prescription drug… Read More

FDA-designated ‘breakthrough’ therapies may not actually be scientific breakthroughs

Stat, April 11, 2018
by Ike Swetlitz, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: WASHINGTON — In a review of three years of drugs approved by the Food and Drug Administration under a “breakthrough therapy” pathway, researchers argue that some of… Read More

Utah’s quixotic Medicaid expansion plan, explained

Vox, April 2, 2018
by Dylan Scott, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Utah wants to expand Medicaid under the Affordable Care Act. Kind of. The state legislature has passed and Gov. Gary Herbert has signed a bill that would partially expand… Read More

Why Did Novartis Spend $9 Billion On Gene Therapy?

Forbes, April 9, 2018
by Matthew Herper

[...] “We're in a journey to focus Novartis as a medicines company powered by data and digital,” chief executive Vas Narasimhan said on a conference call explaining the deal to analysts.… Read More

Medical Marijuana’s ‘Catch-22’

NPR, April 7, 2018
by Marisa Taylor and Melissa Bailey

[...] Although 29 states have legalized marijuana to treat pain and other ailments, the growing number of Americans like Owen who use marijuana and the doctors who treat them are caught in the middle of… Read More

Patient Advocacy Groups Take In Millions From Drugmakers. Is There A Payback?

Kaiser Health News, April 6, 2018
by Emily Kopp, Sydney Lupkin, and Elizabeth Lucas

​Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to… Read More

FDA Commissioner Says Enforcement Power Could Be Used In Right-To-Try, E-Cigarettes

Forbes, March 28, 2018
by Matthew Herper and Ellie Kincaid

The commissioner of the Food and Drug Administration has a single answer to many of the challenges the FDA is likely to face: enforcement. Speaking at the CNBC Healthy Returns conference, FDA commissioner… Read More

Prevalence of Publicly Available Expanded Access Policies

Clinical Pharmacology & Therapeutics, March 23, 2018
by Emily Jung (Petrie-Flom Student Intern), Patricia J. Zettler, Aaron S. Kesselheim

From the Article: The Food and Drug Administration's expanded access program allows patients with serious or immediately life‐threatening conditions to seek access to experimental drugs and treatments… Read More

Between the lines on insurers and drug rebates

Axios Vitals, March 28, 2018
by Sam Baker, citing Rachel E. Sachs (Academic Fellow Alumna)

From the article: UnitedHealthcare and Aetna have committed to lowering some consumers' out-of-pocket drug costs by sharing the rebates that pharmacy benefit managers (PBMs) negotiate with… Read More

Price Insensitivity. Guest, Rachel Sachs

The Week in Health Law, Episode 132, March 22, 2018
by Nicolas Terry and Frank Pasquale, interviewing Rachel Sachs (Academic Fellow Alumna)

From the podcast: This week’s episode features a welcome return from Rachel Sachs, Associate Professor of Law at the Washington University in St. Louis School of Law. Rachel’s primary… Read More

Medicare Is Cracking Down on Opioids. Doctors Fear Pain Patients Will Suffer.

New York Times, March 27, 2018
by Jan Hoffman

Medicare officials thought they had finally figured out how to do their part to fix the troubling problem of opioids being overprescribed to the old and disabled: In 2016, a staggering one in three… Read More

How ‘Bad Medicine’ Dismisses And Misdiagnoses Women’s Symptoms

NPR, March 27, 2018
by Terry Gross, interviewing Maya Dusenbery

[...] Dusenbery says these experiences fit into a larger pattern of gender bias in medicine. Her new book, Doing Harm, makes the case that women's symptoms are often dismissed and misdiagnosed… Read More

Promoting Competition To Address Pharmaceutical Prices

Health Affairs, March 15, 2018
by Jonathan Darrow (Student Fellow Alumnus), Aaron S. Kesselheim

From the article Under ideal market conditions, competition among producers of a commercial good can drive down prices. The market for pharmaceuticals, however, is inefficient in many ways, leading to… Read More

SEC greenlights shareholder proposals for several big drug makers over pricing

STAT, March 26, 2018
by Ed Silverman

The Securities and Exchange Commission agreed to allow shareholders in five large drug makers to vote on a proposal demanding the companies compile reports about the risks created by high prices and also… Read More

Big Pharma, Big Data

New York Times, March 1, 2018
by Reuters

LONDON — Drugmakers are racing to scoop up patient health records and strike deals with technology companies as big data analytics start to unlock a trove of information about how medicines perform… Read More

Trump fires first salvo on drug prices

The Hill, February 12, 2018
by Peter Sullivan, referencing Rachel Sachs (Academic Fellow Alumna)

From the article: President Trump is beginning to move on high drug prices, unveiling a series of modest proposals in his budget request released Monday. It’s the first time Trump has issued major… Read More

Trump teams rolls out new drug pricing ideas

Politico, February 12, 2018
by Sarah Karlin-Smith, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: TRUMP TEAM TAKES ANOTHER STAB AT DRUG PRICES: ARE THEY SERIOUS THIS TIME? — Late last week came two new signs the White House may finally be ready to move beyond rhetoric on… Read More

Budget, White Paper Provide Insight Into Trump Administration’s Strategy On Drug Pricing

Health Affairs, February 12, 2018
by Rachel Sachs (Academic Fellow Alumna)

From the article: During his first year in office, President Donald Trump spoke often about the problem of high drug prices but took no action on the subject. President Trump’s new budget proposal and… Read More

Physicians, ethicists urge Congress not to pass ‘right-to-try’ legislation

Stat, February 1, 2018
by Ike Swetlitz, reporting on Holly Fernandez Lynch (Former Executive Director and Academic Fellow Alumna)

From the article: Dozens of doctors, medical ethicists, and lawyers are warning Congress that legislation to allow Americans with life-threatening conditions access to unapproved, experimental drugs risks… Read More

Analyst in Health Policy
Congressional Research Service (CRS), Domestic Social Policy Division

Deadline: March 02, 2018

SummaryThe Congressional Research Service (CRS), Domestic Social Policy Division is seeking an Analyst in Health Policy to work on issues related to biomedical and health services policy. A general understanding… Read More

White House Calls to Expedite Review of 2nd or 3rd Classes of New Molecular Entities

Regulatory Focus, February 09, 2018
by Zachary Brennan, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: The White House's Council of Economic Advisers on Friday released a report on drug pricing, suggesting changes to the Medicare and Medicaid programs and reforming the US Food and… Read More

Trump’s abandoned promise to bring down drug prices, explained

Vox, February 2, 2018
by Dylan Scott, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: One year into Donald Trump’s presidency, as he delivered his first State of the Union address, he has more or less abandoned his outspoken pledges to bring down the cost of America’s… Read More

The Regulatory Accountability Act of 2017 — Implications for FDA Regulation and Public Health

NEJM, February 1, 2018
by Jonathan J. Darrow (Student Fellow Alumnus), Erin C. Fuse Brown, and Aaron S. Kesselheim

From the article: In the past year, federal health policy has been characterized by pervasive uncertainty, but a consistent theme from the Trump administration and some prominent legislators has been opposition… Read More

Physicians, ethicists urge Congress not to pass ‘right to try’ legislation

STAT News, February 1, 2018
by Ike Swetlitz reporting on Holly Fernandez Lynch (Former Executive Director and Academic Fellow Alumna)

From the article: Dozens of doctors, medical ethicists, and lawyers are warning Congress that legislation to allow Americans with life-threatening conditions access to unapproved, experimental drugs risks… Read More

Pharmaceutical Advertising in Medical Journals

CHEST, Volume 153, Issue 1
by Michael S. Sinha, Aaron S. Kesselheim, and Jonathan J. Darrow (Student Fellow Alumnus)

From the article: Marketing efforts across many industries, including the health-care industry, have shifted toward digital advertising through web-based, social media, and mobile application platforms.… Read More

Trump Pledges To Lower Drug Costs — Can We Do It?

NPR, January 31, 2018
by Anthony Brooks, interviewing Rachel Sachs (Academic Fellow Alumna)

From the podcast: President Trump says in his State of the Union that going after the high cost of prescription drugs is a top priority. Politicians have promised for years to bring them down. We’ll… Read More

The Federal Right to Try Act of 2017

JAMA Internal Medicine, January 22, 2018
by Alison Bateman-House and Christopher T. Robertson (Academic Fellow Alumnus)

From the article: In 2017, President Trump said that “one thing that’s always disturbed”1 him is that the US Food and Drug Administration (FDA) denies access to experimental drugs… Read More

It’s time to levy penalties for failing to report clinical trial results

STAT, January 17, 2018
by Holly Fernandez Lynch (Academic Fellow Alumna and former Executive Director)

From the article: I started my first job as an attorney in the fall of 2007, days after President George W. Bush signed the Food and Drug Administration Amendments Act (FDAAA) into law. As part… Read More

Tip of the Iceberg II

11 NYU Journal of Law & Liberty 770, January 12, 2018
by Christopher T. Robertson (Academic Fellow Alumnus) and Victor Laurien

Abstract In recent years, the Food and Drug Administration’s pre-market approval process has come under increasing scrutiny as an infringement on liberty and a regulation of speech. In the first… Read More

A New Approach to Treat Childhood Leukemia: Novartis’ CAR-T Therapy

The Journal of Law, Medicine & Ethics, January 10, 2018
by Frazer A. Tessema and Jonathan J. Darrow (Student Fellow Alumnus)

From the article: On August 30, 2017, the US Food and Drug Administration (FDA) announced the approval of tisagenlecleucel (Kymriah; CTL019), Novartis' new treatment for B-cell acute lymphoblastic… Read More

Federal Right-to-Try Legislation — Threatening the FDA’s Public Health Mission

NEJM, January 10, 2018
by Steven Joffe and Holly Fernandez Lynch (Academic Fellow Alumna and former Executive Director)

From the article: The Food and Drug Administration (FDA) is the gatekeeper of the country’s drugs and medical devices. Originally created to prevent the misleading of patients, it was later tasked… Read More

A Big Pharma-funded charity that helps patients pay for drugs just sued the government

Washington Post, January 8, 2018
by Carolyn Y. Johnson, quoting Christopher T. Robertson (Academic Fellow Alumnus)

From the article: These charities help patients out, but they also provide a lucrative philanthropic option for donors. Drug companies get reimbursed by government health programs or private… Read More

Drug Policy: The Year In Review, And The Year Ahead

Health Affairs Blog, January 4, 2018
by Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Last year was an unquestionably busy time for health care news of all kinds. Media and policy coverage rightly focused on the many attempts to repeal the Affordable Care Act, but… Read More

This old drug was free. Now it’s $109,500 a year.

The Washington Post, December 18, 2017
by Carolyn Y. Johnson, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: But the price has been on a roller coaster in recent years — zooming from a list price of $50 for a bottle of 100 pills in the early 2000s up to $13,650 in 2015, then plummeting… Read More

Speed, Safety, and Industry Funding — From PDUFA I to PDUFA VI

The New England Journal of Medicine, December 7, 2017
by Jonathan J. Darrow (Student Fellow Alumnus), Jerry Avorn, and Aaron S. Kesselheim

From the paper: In August, President Donald Trump signed into law the sixth version of key legislation for the Food and Drug Administration (FDA), known as the Prescription Drug User Fee Act (PDUFA VI).… Read More

The FDA’s Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016

JAMA, Issue 318, no. 21
by Thomas J. Hwang, Jonathan J. Darrow (Student Fellow Alumnus), Aaron S. Kesselheim

From the paper: The US Food and Drug Administration (FDA) has 4 expedited programs to speed the development and review of drugs treating serious diseases: (1) priority review leads to FDA review in 6 months… Read More

Will inter partes review speed US generic drug entry?

Nature Biotechnology, Issue 35
by Jonathan J Darrow (Student Fellow Alumnus), Reed F Beall & Aaron S Kesselheim

From the paper: Patents are ubiquitous in the pharmaceutical industry and are used by brand-name drug manufacturers to prevent low-cost generic competition and maintain high drug prices. Patents are granted… Read More

Encouraging New Uses for Old Drugs

JAMA, December 4, 2017
by Rachel E. Sachs (Academic Fellow Alumna), Paul B. Ginsburg, and Dana P. Goldman

From the paper: US Food and Drug Administration (FDA) approval of a new drug typically coincides with a period of patent protection, during which the manufacturer will often apply for additional indications… Read More

Sanofi scandal in the Philippines could spread dangerous mistrust of vaccines

STAT, December 11, 2017
by Ed Silverman, quoting I. Glenn Cohen (Faculty Director)

From the article: Unfortunately, there are indications that the company, which could use a blockbuster product, should have taken its corporate foot off the gas pedal.  And to restore confidence in… Read More

Regulating Black-Box Medicine

Michigan Law Review, Vol. 116, Issue 3
by W. Nicholson Price II (Academic Fellow Alumnus)

From the paper: 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 based… Read More

Call for Postdoctoral Fellowship Applications
Harvard Medical School/Brigham and Women’s Hospital Program On Regulation, Therapeutics, And Law (PORTAL)

Deadline: February 16, 2018

The Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital Department of Medicine and Harvard Medical School invites its 2018 round of applications for postdoctoral… Read More

The Health 202

The Washington Post, November 30, 2017
by Paige Winfield Cunninghamm, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: If the opioid epidemic was simply a problem of supply – people being able to access drugs too easily – than a targeted new effort in Appalachia announced… Read More

FDA-Approved Digital Pill Causes Concerns

KJZZ Radio, November 28, 2017
by Steve Goldstein, interviewing I. Glenn Cohen (Faculty Director)

The first so-called digital pill has been approved by the Food and Drug Administration. It’s a version of the antipsychotic drug Abilify and contains a tiny sensor that will send a signal to a patch… Read More

Digital pill offers chance of new life to old drugs

Financial Times, November 22, 2017
by FT Staff, quoting I. Glenn Cohen (Faculty Director)

From the article: Amid broader concerns about how medical information may be used, Proteus says that its product complies with “all applicable laws and standards” on data protection. Patients… Read More

A patent ploy

The Economist, November 16, 2017
by Economist Staff, citing Rachel E. Sachs (Academic Fellow Alumna)

From the article: [...] The Mohawk tribe argues that it should be treated the same as a state institution. State universities have used sovereign immunity to dismiss challenges brought to the Patent… Read More

First Digital Pill Approved to Worries About Biomedical ‘Big Brother’

New York Times, November 13, 2017
by Pam Belluck, featuring I. Glenn Cohen (Faculty Director)

For the first time, the Food and Drug Administration has approved a digital pill — a medication embedded with a sensor that can tell doctors whether, and when, patients take their medicine. The approval,… Read More

Ohio’s Drug-Pricing Ballot Question Triggers Voter Confusion

Kaiser Health News, November 7, 2017
by By Shefali Luthra, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Drug pricing is complex and already has caused head-scratching among policymakers and academics, noted Rachel Sachs, an associate professor of law at Washington University in St. Louis,… Read More

7 ways biopharma would win — and lose — under the new tax bill

STAT News, November 2, 2017
by Rebecca Robbins, citing Rachel E. Sachs (Academic Fellow Alumna)

From the article: [...] The drug industry has fiercely defended this tax credit in the past, calling it essential to encourage investment in disease areas where patients have few options — even as… Read More

Desperate Quest For Herpes Cure Launched ‘Rogue’ Trial

Kaiser Health News, October 19, 2017
by Marisa Taylor, quoting Holly Fernandez Lynch (Former Executive Director, Academic Fellow Alumna)

From the article: As 20 Americans and Brits flew to a Caribbean island for a controversial herpes vaccine trial, many of them knew there were risks. The lead U.S. researcher, William Halford, openly acknowledged… Read More

Medicaid’s Best-Price Rule May Not Be Such a Big Problem

Physician's Weekly, October 23, 2017
by Physician's Weekly, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Rachel Sachs, J.D., M.P.H., from Washington University in St. Louis, and colleagues discussed Medicaid’s “best-price rule” and the extent to which it might frustrate… Read More

Allergan ruling casts doubt on tribal patent strategy

Reuters, October 17, 2017
by Jan Wolfe, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: The company said the PTAB proceeding should be terminated because the tribunal did not have jurisdiction over the tribe. Allergan said it wanted to avoid defending the patent in both… Read More

Judge invalidates Allergan patents and criticizes deal with the Mohawks

STAT, October 16, 2017
by Ed Silverman, quoting Rachel E. Sachs

From the article: In a blow to Allergan (AGN), a federal judge invalidated the patents on its Restasis eye treatment, the latest twist in a captivating controversy over the fate of the best-selling medicine.… Read More

Court Finds Restasis Patents Invalid, Raises Concerns About Allergan, Mohawk Tribe Agreement

RAPS, October 16, 2017
by Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: In an 11-page order separate from the one invalidating the Restasis patents for obviousness, US Circuit Judge William Bryson wrote that the court "has serious concerns about the legitimacy… Read More

Ohio Issue 2 ballot initiative proponents overstate impact on EpiPen prices

Politifact, October 13, 2017
by Manuela Tobias, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: In addition to the Medicaid program, the state purchases drugs for state employees, prisons, and other state-run programs, but the campaign was unable to pin down the effect of the initiative… 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

Call for Papers: Second Annual Regional Health Law Works-in-Progress Retreat
Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy

Deadline: November 17, 2017

Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy is pleased to announce the Second Annual Regional Health Law Works-in-Progress Retreat, which will be… 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

Why a Drug Company Is Selling Patents to a Native American Tribe

Gizmodo, September 12, 2017
by By Ryan F. Mandelbaum, quoting Rachel E. Sachs (Academic Fellow Alumna)

[...] There is concern that this act may be precedent setting, and other companies may also try and transfer patents to Native American tribes to get around these patent lawsuits. Rachel Sachs,… Read More

Allergan’s deal with the Mohawks raises troubling questions about the future of generics

STAT , September 11, 2017
by By Ed Silverman, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: [...] Legal experts, however, say that tribal sovereignty may also thwart generic drug makers from filing a conventional lawsuit. If so, the ramifications may be far-reaching and ominous… 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

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

Bernie Sanders Tells Big Pharma

International Business Times, August 7, 2017
by Josh Keefe, quoting Rachel E. Sachs (Academic Fellow Alumna)

[...] Other experts told IBT federal support of drug development goes well beyond just funding research. “It’s not so much the money we are actually spending through NIH. We are providing huge… 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

The FDA May Move to Shorten That Grim List of Side Effects in Every Drug Ad

STAT News, June 28, 2017
by Megan Thielking, quoting Holly Fernandez Lynch (Executive Director)

From the article: Warning: Watching TV drug ads may put you to sleep. That’s no surprise to many of us who’ve heard about the countless ways prescription drugs can harm us. But now, the Food… Read More

Meet The People Doing Poop Transplants The Government Doesn’t Want Them To

Buzzfeed, June 28, 2017
by Nidhi Subbaraman, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Some scientists and legal experts have suggested that poop be regulated like a tissue — something that was derived from the body, and therefore subject to less stringent… Read More

Panel: Weighing the Risks of Randomized Controlled Trials and Alternatives

The New York Academy of Sciences, June 21, 2017
by Panel featuring Holly Fernandez Lynch (Executive Director), Amrit Ray, Matthew Rotelli, Steve Usdin, and Robert Walker

On June 21, 2017, Executive Director Holly Fernandez Lynch participated in a panel discussion on "Weighing the Risks of Randomized Controlled Trials and Alternatives," which was part of the conference… Read More

Turning to the States to Solve the National Problem of Drug Pricing

STAT News, June 20, 2017
by Meghana Keshavan, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Drug pricing is a national problem. So a nonprofit wants to help hand off some of that burden to the states. The National Academy for State Health Policy just launched a new center, called… Read More

At Drug Hearing, Senators Discuss Meanings of Price and Value - and Debate Health Reform

Health Affairs Blog, June 20, 2017
by Rachel E. Sachs (Academic Fellow Alumna)

From the article by Rachel E. Sachs, (Academic Fellow Alumna): On Tuesday, June 13, the Senate Health, Education, Labor, & Pensions (HELP) Committee held the first of three planned hearings… Read More

This Pharma Company Won’t Commit to Fairly Pricing a Zika Vaccine You Helped Pay For

The Huffington Post, June 9, 2017
by Alexander C. Kaufman, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: “The incentives for any one company to raise its prices or engage in questionable conduct are quite high, while the incentives for the industry as a whole to corral and police its… Read More

How a Supreme Court ruling on printer cartridges could have a big impact on drug prices

STAT News, May 30, 2017
by Meghana Keshavan, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: A Supreme Court ruling on international printer cartridge sales could have major implications for, of all things, drug pricing and global health. The case in question involves patents,… Read More

New Issue of the Journal of Law and the Biosciences

Journal of Law and the Biosciences (JLB), Vol. 4, No. 1, April 2017

The Journal of Law and the Biosciences, the open-access journal launched in 2014 by the Petrie-Flom Center and Harvard Law School in partnership with Duke University and Stanford University, has… 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 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

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

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

FiercePharma, March 21, 2017
by 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… Read More

Maryland Goes a Step Further to Rein in Drug Price Spikes

Regulatory Affairs Professionals Society (RAPS), February 27, 2017
by 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… Read More

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

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

This article is behind a paywall. Read More

Express Scripts CEO addresses drug pricing ‘misinformation’

St. Louis Post-Dispatch, February 17, 2017
by 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… Read More

Call for Papers
European Pharmaceutical Law Review (EPLR)

Deadline: Various

Calll for PapersThe European Pharmaceutical Law Review (EPLR) provides a forum to discuss, comment and review all issues raised by the development and implementation of the law and policy governing the… 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

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

When clinical trials compete: prioritising study recruitment

Journal of Medical Ethics, January 20, 2017 (online)
by Luke Gelinas (Clinical Research Ethics Fellow), Holly Fernandez Lynch (Executive Director), Barbara E. Bierer, and I. Glenn Cohen (Faculty Director)

Abstract It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is,… Read More

Mid-Atlantic Health Law Works-in-Progress Retreat
Seton Hall Law School

Deadline: February 03, 2017

Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy is pleased to announce the inaugural Mid-Atlantic Health Law Works-in-Progress Retreat, which will be held on February… 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

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

Regeneron CEO: Amgen’s disruptive Praluent-blocking patent move hurts patients

FiercePharma, January 10, 2017
by Carly Helfand, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Now, Regeneron and Sanofi will ask the Federal Circuit “to quickly review if we can have a stay, and frankly, the merits of the entire case as quickly as possible,”… Read More

Could Amgen’s Patent Victory Be Bad For Medicine?

Forbes, January 6, 2017
by Matthew Herper, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Last night, in a nearly unprecedented move, a federal judge ordered a cholesterol medicine that is on the market and used by patients to be withdrawn because it infringes on the patents… Read More

If Taxpayers Invent A Drug, Should The Government Just Give It Away?

BuzzFeed News , December 31, 2016
by Dan Vergano, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: The dispute “is not the first time someone has raised questions over NIH’s method of giving exclusive rights to promising drugs,” Washington University law professor… Read More

Harnessing the U.S. Taxpayer to Fight Cancer and Make Profits

New York Times, December 19, 2016
by Matt Richtel and Andrew Pollack, quoting Rachel E. Sachs (Academic Fellow alumna)

From the article: Rachel Sachs, an associate law professor at Washington University in St. Louis and expert in innovation policy, said the government had every right to seek price concessions. She noted… 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

Post-doctoral Fellowship on Research Ethics and Expanded Access to Unapproved Drugs
NYU School of Medicine, Division of Medical Ethics

Deadline: Open until filled.

Training Opportunities: Post-doctoral Fellowship on Research Ethics and Expanded Access to Unapproved Drugs NYU School of Medicine, Department of Population Health, Division of Medical Ethics seeks to… 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

Online J-Term Health Law Courses
875 Summit Ave. | St. Paul, MN 55105

Deadline: January 02, 2017

The Mitchell Hamline School of Law Health Law Institute is pleased to offer two online health law courses in January 2017!                        … 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

ORDER NOW & RECEIVE 30% OFF: Nudging Health

Johns Hopkins University Press, October 2016
by I. Glenn Cohen (Faculty Director), Holly Fernandez Lynch (Executive Director), and Christopher T. Robertson (Academic Fellow alumnus), eds.

Abstract of the Introduction:  This introductory chapter to the edited volume Nudging Health: Health Law and Behavioral Economics (I. Glenn Cohen, Holly Fernandez Lynch, Christopher T. Robertson,… Read More

Proposition 61 Gives California Mandate To Lower Drug Prices, Not Tools

KPBS Midday Edition, October 31, 2016
by Ben Bradford, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Proposition 61 would require Medi-Cal to get VA prices for about 3 million of its patients (it excludes other Medi-Cal patients, who are on managed care plans). Rachel Sachs, a law professor… 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