public static function News, Resources, and Events Tagged "Pharmaceuticals" | Petrie-Flom Center

A groundbreaking antitrust lawsuit is ensnaring the generic drug industry

Vox, December 10, 2018
by By Dylan Scott, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: "The exact damages are difficult to know but likely total in the billions of dollars if the allegations are true. These artificially high prices led to health plans and government programs… Read More

Investigation of generic ‘cartel’ expands to 300 drugs

Washington Post, December 9, 2018
by Christopher Rowland

Executives at more than a dozen generic-drug companies had a form of shorthand to describe how they conducted business, insider lingo worked out over steak dinners, cocktail receptions and rounds of golf.… Read More

Democrats are suddenly eyeing a valuable pharma asset: its patents

Stat, December 7, 2018
by by Lev Facher, quoting Rachel Sachs (Academic Fellow Alumna)

From this article: "Democrats, newly empowered in D.C. and on the hunt for bigger and bolder ways to lower drug prices, are suddenly taking aim at a far more central part of pharma’s monopoly power:… Read More

Democrats are suddenly eyeing a valuable pharma asset: its patents

Stat, December 7, 2018
by by Lev Facher, quoting Rachel Sachs (Academic Fellow Alumna)

From this article: "Democrats, newly empowered in D.C. and on the hunt for bigger and bolder ways to lower drug prices, are suddenly taking aim at a far more central part of pharma’s monopoly power:… Read More

AVAILABLE FOR PRE-ORDER! Transparency in Health and Health Care in the United States

Cambridge University Press, Forthcoming June 2019
by Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar, and Barbara J. Evans (eds.)

This edited volume stems from the Petrie-Flom Center’s 2017 annual conference, which brought together leading experts to reach better understandings of this health policy buzzword, recognizing… Read More

Drug Maker Pays $360 Million to Settle Investigation Into Charity Kickbacks

New York Times, December 6, 2018
by Katie Thomas

The drug maker Actelion Pharmaceuticals has agreed to a $360 million settlement stemming from an investigation into whether the company illegally funneled kickbacks through a patient-assistance charity, federal… Read More

Something Happened to U.S. Drug Costs in the 1990s

New York Times, November 12, 2018
by Austin Frakt quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: “Other countries decline to pay for a drug when the price is too high,” said Rachel Sachs, who studies drug pricing and regulation as an associate professor of law at Washington… Read More

Administration Proposes Strategies To Lower Pharmaceutical Prices In Medicare Part D

Health Affairs, November 28, 2018
by by Rachel Sachs (Academic Fellow Alumna)

From the article: "On Monday, the Trump administration proposed a set of changes that have the potential to lower the prices of some pharmaceuticals paid for through Medicare Part D.… Read More

3 More States OK Easing Their Marijuana Laws

NPR, November 7, 2018
by Bill Chappell

Voters in Michigan approved a ballot measure to legalize recreational use of marijuana on Tuesday, and two other states — Missouri and Utah — endorsed medical marijuana laws. Voters in North… Read More

Trump prescription medication plan drawing skepticism

Boston Herald, November 3, 2018
by Alexi Cohan, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Part of the proposal includes adopting an international pricing index for reimbursement that is based off the cost of certain drugs in other countries. This would lower the cost here… Read More

The Health 202: There will be a big fight over Trump’s new proposal to lower drug prices

Washington Post, October 26, 2018
by Paige Winfield Cunningham, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: But the plan does signify the administration is serious about taking action on drug prices. The Obama administration made a similar effort, which it ultimately abandoned under… Read More

Administration Outlines Plan To Lower Pharmaceutical Prices In Medicare Part B

Health Affairs, October 26, 2018
by Rachel Sachs (Academic Fellow Alumna)

From the article: Yesterday, the Trump Administration outlined a plan that, if implemented, could significantly lower the prices of pharmaceuticals through Medicare Part B. The plan… Read More

Trump leans into midterms with a pitch to un-rig Medicare drug prices

CNN Politics, October 25, 2018
by Tami Luhby and Lauren Fox, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  While Trump officials could use an Obamacare-created innovation center to pilot new payment proposals, it would have to take a hard stance on prices. "We don't negotiate because… Read More

Coming today: Trump’s most aggressive drug pricing move yet

Politico, October 25, 2018
by Dan Diamond, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Some policy experts cheered Trump's ideas, although they had questions about how the plan would work — "If companies won't sell to Medicare at the benchmark price,… Read More

Advance notice of mysterious rule puts drug-pricing people on edge

Politico Prescription Pulse, October 22, 2018
by Sarah Karlin-Smith, featuring Holly Fernandez Lynch (Former Executive Director)

From the article:  Holly Fernandez Lynch, a medical ethicist at the University of Pennsylvania, wonders whether FDA will audit third-party invoices to make sure manufacturers aren’t profiting… Read More

A Billionaire Pledges to Fight High Drug Prices, and the Industry Is Rattled

Wall Street Journal, October 21, 2018
by Peter Loftus

HOUSTON—Billionaire John D. Arnold is spending a chunk of his fortune to campaign against America’s high drug prices. The drug industry is spending a chunk of its fortune to counter him. [...] Read More

Trump Administration Wants TV Drug Ads To Include A Price

WFPL, October 20, 2018
by Lisa Gillespie, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Rachel Sachs, an associate professor of law and a drug regulation expert at Washington University, said that the proposal is very narrow and doesn’t do anything for transparency… Read More

Rachel Sachs of Washington University on the USMCA

SiriusXM Radio, October 18, 2018
by Joe Madison the Black Eagle, interviewing Rachel Sachs

From the article: NAFTA (the North American Free Trade Agreement) has become the USCMA (U.S., Mexico, and Canada Agreement). What does that mean for you? Professor Rachel Sachs of Washington University… Read More

Requiring Price Info in Drug Ads May Strain Agency Authority

Bloomberg Law, October 17, 2018
by Dana A. Elfin, quoting Rachel Sachs

From the article: “I’m skeptical of HHS’ arguments that [the Center for Medicare and Medicaid Services] has the authority to issue this reg,” Rachel Sachs, associate professor of… Read More

5 questions on the Trump admin’s bid to mandate prices in drug ads

Biopharma Dive, October 16, 2018
by Ned Pagliarulo and Andrew Dunn, quoting Rachel Sachs

From the article: HHS argues that it has the authority to require price disclosures in ads through the Social Security Act, which tasks it with the "efficient" administration of the Medicare and Medicaid… Read More

Trump issues rule to require drug prices in TV ads, rejecting industry plan

Politico, October 15, 2018
by Sarah Karlin-Smith

The Trump administration on Monday moved to require drugmakers to disclose prices in consumer ads, just hours after branding a pharmaceutical industry transparency plan as inadequate. HHS said its proposed… Read More

Trump issues rule to require drug prices in TV ads, rejecting industry plan

Politico, October 15, 2018
by Sarah Karlin Smith, quoting Rachel Sachs

From the article: A majority of voters tends to support the transparency move but remains skeptical of whether it will lead to lower drug costs. A July POLITICO/Harvard poll found 63 percent of Americans… Read More

Should TV Drug Ads Be Forced To Include A Price? Trump’s Team Says Yes

NPR's Morning Addition, October 15, 2018
by Shefali Luthra and Sarah Lane Tribble, quoting Rachel Sachs

From the article: "It is noteworthy that the government is unwilling to take enforcement action," said Rachel Sachs, an associate professor of law at Washington University in St. Louis and an expert… Read More

Pharma’s new plan to put more info — but not drug list prices — in TV ads

Vox, October 15, 2018
by Dylan Scott, quoting Rachel Sachs

From the article: Policy experts were already unimpressed with the Trump administration’s idea of requiring list prices to be included in ads, mostly because there is no real mechanism to lower prices… Read More

Drugmakers may have to disclose prices of medicine in television ads

Washington Post, October 15, 2018
by Amy Goldstein and Carolyn Y Johnson, quoting Rachel Sachs

From the article: Rachel Sachs, an associate professor of law at Washington University in St. Louis School of Law, said that it is unclear how or why disclosures would reduce drug prices. “The administration… Read More

Drugmakers may have to disclose prices of medicine in television ads

Washington Post, October 15, 2018
by Amy Goldstein and Carolyn Y Johnson, quoting Rachel Sachs

From the article: Rachel Sachs, an associate professor of law at Washington University in St. Louis School of Law, said that it is unclear how or why disclosures would reduce drug prices. “The administration… Read More

A growing number of states consider legislation to treat pharma as a utility

STAT, October 10, 2018
by Ed Silverman

As prescription drug costs continue to frazzle Americans, lawmakers in several states are pushing to create commissions that would set prices that health plans, pharmacies, and state programs would pay… Read More

No More Secrets

Kaiser Health News, October 10, 2018
by Susan Jaffe

For years, most pharmacists couldn’t give customers even a clue about an easy way to save money on prescription drugs. But the restraints are coming off. When the cash price for a prescription is… Read More

DOJ Clears CVS-Aetna Deal Once Medicare Drug Plans Are Unloaded

Forbes, October 10, 2018
by Bruce Japsen

The U.S. Justice Department Wednesday agreed to allow CVS Health's acquisition of health insurance giant Aetna once Aetna's Medicare Part D prescription drug plan business for individuals… Read More

The exciting new idea hospitals have to bring down drug prices

Vox, October 8, 2018
by Dylan Scott, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  To fully appreciate the scope of the generic drug pricing problem, remember that the Justice Department and 45 states are currently in court accusing generic drug makers of… Read More

Addiction Treatment Gap Is Driving A Black Market For Suboxone

NPR, October 5, 2018
by Jake Harper

[...] Buprenorphine is one of just three federally approved medications to treat opioid addiction. It's an opioid itself, so some people misuse it — they snort or inject the medication to… Read More

Yes, PTAB proceedings against Orange Book patents are on the up. No, they’re not wiping them out

IAM Media, October 1, 2018
by Adam Houldsworth, featuring work by Jonathan Darrow

From the article: Further data has emerged showing that the Patent Trial and Appeal Board (PTAB) is far from the “death squad” that many in the US life sciences industries fear that it may… Read More

When Markets Fail: Patents and Infectious Disease Products

Food and Drug Law Journal, September 2018, Volume 73, Number 3
by Jonathan J. Darrow, Michael S. Sinha, and Aaron S. Kesselheim

From the abstract:  New antibiotics and vaccines aimed at treating or preventing infectious diseases can be highly valuable public health innovations, particularly when these products address… Read More

Gilead to launch authorized generics of two HCV drugs

Chemical and Engineering News, September 26, 2018
by Lisa M. Jarvis, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: The effect on costs for patients and overall spending remains to be seen. “It’s unlikely this will result in lower government spending because this is what governments were… Read More

Pharma Dealt A Disappointment Over ‘Doughnut Hole’ Change As Lawmakers Reach Agreement On Opioid Pac

Kaiser Health News, September 26, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Negotiators for the House and Senate smoothed out the differences between their two versions on the massive… Read More

Researchers Point to R&D Treaty to Spur New Infectious Disease Treatments

RAPS Regulatory Focus , September 24, 2018
by Zachary Brennan, quoting Jonathon Darrow (Student Fellow Alumnus)

From the article:  As current incentives to promote the development of new infectious disease treatments have yet to reach their potential, researchers in a new Food and Drug Law Journal paper… Read More

GOP lawmakers seeking to use opioids bill to deliver drug industry major victory

STAT + , September 20, 2018
by Lev Facher and Nicholas Forko

This article is behind a paywall. WASHINGTON — Republicans on Capitol Hill are attempting to use a bill to address the opioid crisis to deliver a major victory for the pharmaceutical industry,… Read More

The Ethics of Smart Pills and Self-Acting Devices

American Journal of Bioethics, September 20, 2018
by Craig M. Klugman, Laura B. Dunn, Jack Schwartz, and I. Glenn Cohen (Faculty Director)

From the abstract:  Digital medicine is a medical treatment that combines technology with drug delivery. The promises of this combination are continuous and remote monitoring, better disease management,… Read More

Smart pills can transmit data to your doctors, but what about privacy?

New Scientist, September 19, 2018
by I. Glenn Cohen (Faculty Director) and Alex Pearlman (Communications Manager)

From the article:  Abilify MyCite, a pill-app combination that can be used to track the ingestion of drugs for bipolar disorder and schizophrenia, was the first such product approved by the US Food… Read More

Watchdog slams safeguards for foster kids on psych drugs

AP News, September 17, 2018
by Ricardo Alonso-Zaldivar

WASHINGTON (AP) — Thousands of foster children may be getting powerful psychiatric drugs prescribed to them without basic safeguards, says a federal watchdog agency that found a failure to care for… Read More

Feds approve Cigna-Express Scripts mega-merger

Politico, September 17, 2018
by Paul Demko

Federal regulators have approved health insurer Cigna’s $52 billion acquisition of drug benefits manager Express Scripts, a mega deal that's the latest evidence of health care giants bulking… Read More

Gottlieb pitches ‘subscriptions’ to incentivize pharma to make new antibiotics

STAT, September 14, 2018
by Ike Swetlitz

ASHINGTON — The Food and Drug Administration is talking with other federal agencies and even the private Bill and Melinda Gates Foundation about new ways to encourage drug makers to develop more antibiotics,… Read More

How the Centers for Disease Control and Prevention responds to a hurricane like Florence

LA Times, September 14, 2018
by Melissa Healy

For all the political chatter about the human toll of hurricanes, one lesson of past monster storms is clear and increasingly urgent: Hurricanes claim lives and erode health before, during and after the… Read More

A pharma exec raised the price of antibiotic by 400 percent — and the government can’t do much about

Stat Plus, September 11, 2018
by Ike Swetlitz and Nicholas Florko, quoting Rachel Sachs (Academic Fellow Alumnus)

From the article:  Three years after Martin Shkreli became the poster boy of pharmaceutical company greed, another drug company executive is setting himself up for a similar infamy. And… Read More

A Setback For Massachusetts In States’ Drive To Contain Medicaid Drug Spending

NPR Shots/WBUR, September 12, 2018
by Martha Bebinger, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  States serve as "laboratories of democracy," as U.S. Supreme Court Justice Louis Brandeis famously said. And states are also labs for health policy, launching all kinds of experiments… Read More

Study: Generic Drug Industry Embraces Faster, Cheaper Pathway For Challenging Patents

Intellectual Property Watch, September 6, 2018
by William New, quoting Jonathan Darrow (Student Fellow Alumnus)

From the article:  A newly released study shows that generic drug companies win nearly half the time when challenging patents on United States government-approved pharmaceutical products through the… Read More

Generic Drugmakers Embrace Inter Partes Review Process

RAPS Regulatory Focus , September 4, 2018
by Zachary Brennan. quoting Jonathan Darrow (Student Fellow Alumnus)

From the article:  [Generic Drugmakers Embrace Inter Partes Review Process]Thanks to Congress’ administrative alternative to court litigation of patents, generic drug manufacturers have embraced… Read More

New Medicare Advantage Tool To Control Drug Prices Could Narrow Choices

NPR, September 13, 2018
by Susan Jaffe

Starting next year, Medicare Advantage plans will be able to add restrictions on expensive, injectable drugs administered by doctors to treat cancer, rheumatoid arthritis, macular degeneration and other… Read More

Limiting State Flexibility in Drug Pricing

NEJM, September 13, 2018
by Nicholas Bagley and Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked… Read More

Are Fraud and Abuse Laws Stifling Value-Based Care?

NEJM Catalyst , September 12, 2018
by Carmel Shachar (Executive Director)

From the article:  While health care delivery and financing should not be a free-for-all, designing the exemptions to explicitly conform to specific regulatory programs does not best serve the system.… Read More

The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents

Applied Health Economics and Health Policy, August 2018, Vol. 14, Issue 73
by Jonathan J. Darrow (Student Fellow Alumnus), Reed F. Beall, Aaron S. Kesselheim

From the abstract:  Background Most new brand-name drugs are protected by patents from generic competition, but these patents are occasionally granted in error. Invalidating such patents has traditionally… Read More

FDA confronts its limits in push on drug pricing

Biopharmadive, August 27, 2018
by Ned Pagliarulo, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  Drugmakers like AbbVie, which makes the best-selling biologic Humira (adalimumab), have reached settlement deals with makers of approved biosimilars to push off market… Read More

Drug Prices in Ads: Senate Passes Amendment

RAPS Regulatory Focus, August 24, 2018
by Zachary Brennan, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  Earlier this month, CMS also announced plans to begin using what’s called step therapy to try to lower the spend on Part B drugs by about 20% in Medicare Advantage… Read More

HHS offers scant evidence Trump’s drug blueprint putting brakes on price hikes

S&P Global Market Intelligence, August 22, 2018
by Donna Young, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  Health and Human Services provided scant evidence, filled with caveats, to back up its chief's claim that drugmakers were responding to the Trump administration's plan… Read More

Drug Pricing Policy

Health Affairs Blog, August 14, 2018
by Rachel E. Sachs (Academic Fellow Alumna)

From the post:  Last Tuesday, the Centers for Medicare and Medicaid Services (CMS) took its latest action in the area of drug pricing. CMS gave Medicare Advantage (MA) plans the ability… Read More

Viewpoint: Promoting Patient Interests in Implementing the Federal Right to Try Act

JAMA, August 13, 2018
by Holly Fernandez Lynch (former Executive Director and Academic Fellow Alumna), Patricia J. Zettler, Ameet Sarpatwari

Former Executive Director and Academic Fellow Alumna Holly Fernandez Lynch has co-authored an opinion piece on the federal Right to Try Act of 2017. From the article: On May 30, 2018, President Trump signed… Read More

The Trump admin has another pretty good, pretty modest plan to lower drug costs

Vox, August 13, 2018
by Dylan Scott, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: “My concern is that once again, the administration’s rhetoric is out of step with its actual policy moves,” Sachs said. “The administration is promoting this move… Read More

Perspective: Will Courts Allow States to Regulate Drug Prices?

NEJM, August 8, 2018
by Christopher Robertson (Academic Fellow Alumnus)

From the article: Pharmaceuticals are consuming increasingly large portions of U.S. state budgets, and high prices are preventing patients from getting, and adhering to, essential medicines. In mid-May… Read More

Report blames gaming of patent system for high drug prices

Med City News, August 9, 2018
by Alaric Dearment, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] The report, “Overpatented, Overpriced: How Excessive Pharmaceutical Patenting is Extending Monopolies and Driving up Drug Prices,” was released last week by the nonprofit Initiative… Read More

CMS’ plan to lower drug spending in Medicare Advantage

Politico Pulse, August 8, 2018
by Brianna Ehley, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Some viewed the step as a bit of a letdown, since HHS Secretary Alex Azar has been touting more sweeping changes to drug prices in Medicare Part B, like letting the private sector insurance… Read More

Here’s what’s behind the ads accusing Bob Hugin of ‘killing off cancer patients’

northjersey.com, August 7, 2018
by Herb Jackson, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: "They're resorting to tactics the FDA criticized. Under the guise of patient safety, this is really about preserving a monopoly position," said law professor Rachel Sachs, who teaches at… Read More

To Tame Prescription Prices, HHS Dips A Toe Into Drug Importation Stream

Kaiser Health News, August 1, 2018
by Rachel Bluth, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: This isn’t the first time officials have suggested importing drugs from other countries to find better prices. Bills have been offered in Congress to allow it, and George… Read More

Drug Approval in a Learning Health System

Minnesota Law Review, 2018
by W. Nicholson Price

From the abstract: The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA — and the health system generally… Read More

Patent term restoration for top-selling drugs in the USA

Drug Discovery Today, July 25, 2018
by Reed F. Beall, Jonathan Darrow (Former Student Fellow), and Aaron S. Kesselheim

From the article:  Patents temporarily protect brand-name drugs from generic competition, but some of the 20-year patent term is used up before marketing approval. To compensate for patent life lost… Read More

The Health 202: This mother’s tweet about drug prices went viral. Trump’s plans are unlikely to help

Washington Post, July 24, 2018
by by Colby Itkowitz, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: “It’s going to take a lot of time and there's a lot of hurdles in the way, but that’s not what you want to explain when you want to show how you’re lowering… Read More

Unpacking the bold — and the bluster — in Trump’s plan to bring down drug prices

STAT, July 23, 2018
by by Erin Mershon, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: The administration says the proposal will save Medicare money, which could translate into lower premiums. It will also mean lower co-pays for any beneficiary who might need a new drug… Read More

The Trump administration finally has one good idea to lower drug prices

Vox, July 20, 2018
by by Dylan Scott, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Right now, in the above circumstances and when there isn’t an actual drug shortage, “we don’t have a good policy solution,” Scott Gottlieb, the FDA commissioner,… Read More

Update: UK Ministers Quit Over Brexit

BBC, July 9, 2018
by Interview featuring Rachel Sachs (Academic Fellow Alumna)

From the interview: We consider the implications for Brexit as two senior UK ministers resign. David Henig is UK director of the European Centre For International Political Economy. He explains why this… Read More

HHS forced to choose migrants over medicines

Politico, July 18, 2018
by By Dan Diamond, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Echoing the pharma industry, Verma stressed that the state's request violated current law — the first time she's publicly cited a legal defense. “f you want to go… Read More

What Pfizer, Trump, and consumers got out of a surprising deal — and what they didn’t

STAT, July 11, 2018
by By Erin Mershon and Ike Swetlitz, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: After months of pledging he would get pharmaceutical companies to lower their prices, President Trump can now say that he pressed the CEO of a major drug maker, Pfizer, to back… Read More

The News on Drug Prices? Nothing Good

The New York Times, July 17, 2018
by By The Editorial Board, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: “It takes away a substantial tool that a lot of states were hoping to use,” says Rachel Sachs, a law professor and drug policy expert at Washington University in St. Louis.… Read More

Donald Trump’s phony war on high prescription drug prices, explained

Vox, July 13, 2018
by By Dylan Scott, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Pfizer ended up agreeing to postpone its price hikes for now. The president was happy to take credit for that news, even if all he had really won was a temporary delay. Certainly not… Read More

As Arkansas ushers in new Trump-era Medicaid rules, thousands fear losing benefits

Reuters, July 10, 2018
by By Yasmeen Abutaleb, quoting Allison K. Hoffman (Academic Fellow Alumna)

From the article: Days after the ruling, Kentucky Governor Matt Bevin cut dental and vision benefits for some 460,000 state Medicaid recipients, saying the benefits were dependent on implementation of… Read More

Understanding the Development Challenges Associated with Emerging Non-Traditional Antibiotics

Duke-Margolis Center for Heath Policy, June 14, 2018
by Webcast featuring Jonathan J. Darrow (Student Fellow Alumnus)

From the webcast: Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this public event will focus on the range of… Read More

CMS quit test of pricey cancer treatment amid concerns over industry role

Politico, July 9, 2018
by By Sarah Karlin-Smith and David Pittman, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: “Coming from an administration which has a stated goal of trying to reduce drug pricing, trying to reduce overall drug spending and health care spending … at every turn this… Read More

Viagra goes up AGAIN

Daily Mail, July 2, 2018
by By Mia De Graaf, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Economists are now calling on the Department of Health and Human Services to clarify what kind of measures they were planning on levying against companies that did not stick to the plan. … Read More

Tempering Expectations of Breakthrough Therapy Designated Drugs

Journal of Clinical Pathways, June 10, 2018
by Interviewing Jonathan J. Darrow (Student Fellow Alumnus)

From the interview: A recent study published in the Journal of Clinical Oncology (online June 20, 2018; doi:10.1200/JCO/2017.77.1592) sought to evaluate the United States Food and Drug Administration… Read More

Call for Proposals Enforcement, Litigation, and Compliance Conference
Food and Drug Law Institute

Deadline: August 09, 2018

The annual Enforcement, Litigation, and Compliance Conference brings together industry, regulators, attorneys, litigators, academics, and consultants to discuss trends and issues in enforcement and compliance,… Read More

Call for Submissions, Glenn Sonnedecker Prize
American Institute of the History of Pharmacy

Deadline: August 15, 2018

General Description The American Institute of the History of Pharmacy is pleased to announce a call for submissions for the 2018 Glenn Sonnedecker Prize. This prize honors the contributions of Glenn Sonnedecker… Read More

A Method for Approximating Future Entry of Generic Drugs

Value in Health Journal, June 11, 2018
by Jonathan J. Darrow, SJD, JD, MBA, (Student fellow alumnus) Aaron S. Kesselheim, MD, JD, MPH, Reed F. Beall, PhD

From the abstract:  Objectives To develop and test a method for approximating generic entry of top-selling drugs. Methods The procedure involved 1) identifying products’ key patents as those… Read More

Precision Medicines Approved More Quickly, With Less Data

MedPage Today, May 25, 2018
by Shannon Firth, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: Pivotal trials for precision medicines were scarcer, less likely to be controlled or blinded, and had fewer participants than those for other agents, the study found.  The less rigorous… Read More

JAMA Forum: The Risks and Benefits of Expedited Drug Reviews

JAMA Forum, May 23, 2018
by Austin Frakt, citing paper co-authored by Jonathan J. Darrow (Student Fellow Alumnus)

From the article: The US Food and Drug Administration (FDA) oversees several programs that expedite approval of certain drugs that treat serious conditions and address unmet medical needs. On average,… Read More

Trump unveils plan to cut drug prices

The Lancet, June 2, 2018, vol. 391, no. 10136
by Susan Jaffe, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: A trade association that represents PBMs disagrees. Eliminating rebates would leave patients and insurers “at the mercy of drug manufacturer pricing strategies”, according… Read More

Is Trump giving the EU higher drug prices too?

DW, June 1, 2018
by Lindsey Rae Gjording, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Through single-payer health care systems the EU is able to regulate consumer costs at reasonable levels. It also makes decisions about what new drugs are worth spending taxpayer money… Read More

Trump Wants Medicaid to Push for Lower Drug Prices – But Will Patients Be Hurt?

PEW, May 30, 2018
by Michael Ollove, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: While 74 percent of closed formularies result in lower prices, 21 percent result in price increases, a 2016 report in the American Journal of Managed Care found. And 29… Read More

Vermont legislators pass a drug importation law. So what?

Salon, May 27, 2018
by Shefali Luthra, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Importation backers — including the National Academy for State Health Policy (NASHP), which helped craft Vermont’s bill and has worked with state lawmakers — hope he’ll… Read More

Criticism of ‘right to try’ law for experimental drugs after it passes in US

Chemistry World, June 5, 2018
by Anthony King, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article:  The US government has controversially announced that it will allow unapproved, experimental drugs to be given to terminally ill patients. The ‘right to try’ law passed… Read More

ALS patients losing time and hope as they wait for insurers to cover a pricey new drug

STAT, May 21, 2018
by Ed Silverman, quoting I. Glenn Cohen (Faculty Director)

From the article: For the past two years, Sarah Benoit has been getting around with the help of a walker, waiting for a medicine that’s out of reach. Benoit, a former congressional aide, has ALS,… Read More

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

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

Little Benefit to Breakthrough Cancer Drugs

Cancer Discovery, May 16, 2018
by Catherine Caruso, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: In 2012, the FDA created the breakthrough therapy designation to speed up the development and review of drugs intended to treat serious or life-threatening diseases when preliminary clinical… 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

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

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

From the article: It was 2015 when Martin Shkreli, then CEO of Turing Pharmaceuticals and the notorious “pharma bro,” jacked up the cost of the lifesaving drug Daraprim by 5,000 percent. Overnight,… 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

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

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

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

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

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

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

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

House passes right-to-try on second try

Politico, March 21, 2018
by Sarah Karlin-Smith, quoting Christopher T. Robertson (Academic Fellow alumnus)

From the Article: The House of Representatives passed on party lines Wednesday evening a bill designed to let very sick patients request access to experimental medicines without government oversight. The… 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

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

Summary The 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