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Pediatric Drug and Other Shortages in the Age of Supply Chain Disruption image

Pediatric Drug and Other Shortages in the Age of Supply Chain Disruption

Carmel Shachar, Philip A. Gruppuso, and Eli Y. Adashi
JAMA

The last year witnessed several significant shortages of key medicines and other products for children, including children’s formulations of acetaminophen and ibuprofen as well as frontline antibiotics prescribed…

Patient-Assistance Programs, Kickbacks, and the Courts image

Patient-Assistance Programs, Kickbacks, and the Courts

Jacob T. Elberg, Eli Y. Adashi, and Glenn Cohen
New England Journal of Medicine

Pharmaceutical companies have sought to reduce cost sharing by means of patient-assistance programs. Some such programs have been under scrutiny because of questions about whether they violate federal law.

 The Antibody Patent Paradox image

The Antibody Patent Paradox

Cited in Amgen v. Sanofi (2023), by Mark A. Lemley and Jacob S. Sherkow
Yale Law Journal

The immune system produces antibodies as a defense to foreign agents called antigens. When a particular anti- gen—a virus, for example—enters the body, the immune system…

Supreme Court Sides with Sanofi, Regeneron in Patent Fight with Amgen image

Supreme Court Sides with Sanofi, Regeneron in Patent Fight with Amgen

Christopher Newman, featuring Jacob Sherkow
Biopharma Dive

Gorsuch acknowledged a patent does not need to disclose each single possible embodiment of the invention. But he added that examples of the claimed class need to have some common…

CBO projects Senate drug pricing bill would cut the development of 10 drugs over 30 years image

CBO projects Senate drug pricing bill would cut the development of 10 drugs over 30 years

Zachary Brennan, featuring Rachel Sachs (Former Postdoctoral Fellow)
Endpoints News

“The reason the number is smaller is that the package has changed over time,” Rachel Sachs, a law professor at Washington University in St. Louis told Endpoints News.…

Here’s what Democrats changed in their latest drug pricing bill

Rachel Cohrs, featuring Rachel Sachs (Former Postdoctoral Fellow)
STAT+

The text released Wednesday is similar to a sweeping package that passed the House last year — it would allow Medicare to negotiate prices with drugmakers, it would protect seniors…

Demand Rising for ‘Bootlegged’ Weight-Loss Drug image

Demand Rising for ‘Bootlegged’ Weight-Loss Drug

Sophie Putka, featuring Jacob Sherkow (Former Fellow-in-Residence)
MedPage Today

Pharma Patents Threatened by Federal Circuit, Petitions Say image

Pharma Patents Threatened by Federal Circuit, Petitions Say

Samantha Handler, quoting Jacob Sherkow (Former Fellow-in-Residence)
Bloomberg Law

If the Juno and Amgen decisions are left in place by the Supreme Court, no attempt to define an antibody will be enough to satisfy the Federal Circuit, said …

Generating Evidence from Expanded Access Use of Rare Disease Medicines: Challenges and Recommendations image

Generating Evidence from Expanded Access Use of Rare Disease Medicines: Challenges and Recommendations

Tobias B. Polak, David G. J. Cucchi, Joost van Rosmalen, Carin A. Uyl-de Groot, and Jonathan J. Darrow (Former Student Fellow)
Frontiers in Pharmacology

Patients with rare diseases often have limited or no options for approved treatments or participation in clinical trials. In such cases, expanded access (or “compassionate use”) provides a…

FDA’s breakthrough device program, meant to benefit patients, is delivering the biggest gains for companies image

FDA’s breakthrough device program, meant to benefit patients, is delivering the biggest gains for companies

Katie Palmer and Mario Aguilar, featuring Jonathan J. Darrow (Former Student Fellow)
STAT+

Five years ago, the Food and Drug Administration launched a new program with the best of intentions: to speed the development and review of cutting-edge and potentially lifesaving medical devices,…

Incremental benefits of novel pharmaceuticals in the UK: a cross-sectional analysis of NICE technology appraisals from 2010 to 2020 image

Incremental benefits of novel pharmaceuticals in the UK: a cross-sectional analysis of NICE technology appraisals from 2010 to 2020

Tobias B. Polak, David G.J. Cucchi, Jonathan J. Darrow (Former Student Fellow), and Matthijs M. Versteegh
BMJ Open

Objectives: To evaluate the incremental value of new drugs across disease areas receiving favourable coverage decisions by the UK's National Institute for Health and Care Excellence (NICE) over…

Controversial Alzheimer’s drug approval ignites FDA reform debate image

Controversial Alzheimer’s drug approval ignites FDA reform debate

Cailtin Owens, featuring Rachel Sachs (Former Academic Fellow)
Axios

The FDA's conditional approval of a controversial Alzheimer's drug last year has sparked heightened scrutiny and an attempted overhaul of a popular regulatory pathway used to fast-track…

Strategies to Manage Drugs and Devices Approved Based on Limited Evidence image

Strategies to Manage Drugs and Devices Approved Based on Limited Evidence: Results of a Modified Delphi Panel

Sanket S. Dhruva, Jonathan J. Darrow (Former Student Fellow), Aaron S. Kesselheim, and Rita F. Redberg
Clinical Pharmacology and Therapeutics

Prescription drugs and medical devices are increasingly coming to market through expedited US Food and Drug Administration (FDA) pathways that require only limited evidence of safety and efficacy, such as…

Institutional Review Board Use of Outside Experts: What Do We Know? image

Institutional Review Board Use of Outside Experts: What Do We Know?

Kimberley Serpico, Vasiliki Rahimzadeh, Emily E. Anderson, Luke Gelinas, and Holly Fernandez Lynch (Former Executive Director)
Ethics and Human Research

Institutional review boards (IRBs) are permitted by regulation to seek assistance from outside experts when reviewing research applications that are beyond the scope of expertise represented in their membership. There…

As states push their own privacy laws, health tech companies fear compliance nightmare image

As states push their own privacy laws, health tech companies fear compliance nightmare

Mohana Ravindranath, featuring Carmel Shachar (Executive Director)
STAT+

Health tech companies worried that an emerging patchwork of state privacy laws will drive up regulatory costs are joining privacy hardliners in the call for one nationwide standard to govern…

Opinion: A placebo-controlled trial requirement from CMS will spell the end of Biogen’s controversial Alzheimer’s drug image

Opinion: A placebo-controlled trial requirement from CMS will spell the end of Biogen’s controversial Alzheimer’s drug

Zachary Brennan, featuring Rachel Sachs (Former Academic Fellow)
Endpoints News

“Biogen’s FDA approval was always contingent on the completion of a confirmatory clinical trial,” Washington University in St. Louis law professor Rachel Sachs told Endpoints. &ldquo…

The USC-Brookings Schaeffer Initiative for Health Policy Welcomes Three New Non-Resident Fellows image

The USC-Brookings Schaeffer Initiative for Health Policy Welcomes Three New Non-Resident Fellows

Brieanna Nicker, featuring Rachel Sachs (Former Academic Fellow)
Brookings

Rachel Sachs is the Treiman Professor of Law at Washington University in St. Louis School of Law. She is a scholar of innovation policy, exploring health law, food and drug…

Finally, Medicare Takes A Step Towards Cost-Control - And Alzheimer’s Advocates Push Back image

Finally, Medicare Takes A Step Towards Cost-Control - And Alzheimer’s Advocates Push Back

Elizabeth Bauer, featuring Rachel Sachs (Former Academic Fellow)
Forbes

Back last June, the FDA made the controversial decision to approve a medication intended to treat Alzheimer’s disease, despite the lack of solid evidence of that drug&rsquo…

Understanding Medicare’s Aduhelm Coverage Decision image

Understanding Medicare’s Aduhelm Coverage Decision

Rachel Sachs (Former Academic Fellow)
HealthAffairs

Yesterday, the Centers for Medicare and Medicaid Services (CMS) issued a draft National Coverage Determination (NCD) proposing that monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s…

Medicare’s Unprecedented Alzheimer’s Drug Decision image

Medicare’s Unprecedented Alzheimer’s Drug Decision

Featuring Rachel Sachs (Former Academic Fellow)
Tradeoffs

Last week, Medicare took an unprecedented step to restrict patients’ access to the first new treatment for Alzheimer’s disease in nearly 20 years. We talk with a doctor,…

Pharmacies shouldn’t be the only place to get Paxlovid, the new Covid pill image

Pharmacies shouldn’t be the only place to get Paxlovid, the new Covid pill

Holly Fernandez Lynch (Former Executive Director) and Keith Hamilton
STAT News

It’s easy to feel like we’re in a pandemic “Groundhog Day” loop as the U.S. faces yet another Covid-19 surge with overwhelmed hospitals,…

Patent thickets are thwarting U.S. availability of lower-cost biosimilar medicines, study finds image

Patent thickets are thwarting U.S. availability of lower-cost biosimilar medicines, study finds

Ed Silverman, featuring Jacob S. Sherkow (Former Edmond J. Safra/Petrie-Flom Centers Joint Fellow-in-Residence)
STAT Plus

Amid debate over competition in the pharmaceutical industry, a new analysis found just 6% of patents covered key ingredients — or innovative new molecules — in pricey biologic medicines, underscoring concerns…

Could Alzheimer’s Drugs Avoid Medicare Coverage Restrictions If They Are Covered By Part D? image

Could Alzheimer’s Drugs Avoid Medicare Coverage Restrictions If They Are Covered By Part D?

Cathy Kelly, featuring Rachel Sachs (Former Academic Fellow)
Pink Sheet

Biogen exec suggests subcutaneous injectable forms of Alzheimer’s treatments subject to Medicare’s draft national coverage determination might find better patient access if they are covered by…

Medicare proposes limiting coverage of controversial Alzheimer’s drug image

Medicare proposes limiting coverage of controversial Alzheimer’s drug

Lily Jamali, featuring Rachel Sachs (Former Academic Fellow)
Marketplace

Shares of drugmaker Biogen tumbled almost 7% yesterday after Medicare placed limits on its coverage of the company’s new Alzheimer’s drug. Biogen had already slashed the price…

Alzheimer’s groups vow to fight proposed Medicare restrictions on controversial drug image

Alzheimer’s groups vow to fight proposed Medicare restrictions on controversial drug

Laurie McGinley, featuring Rachel Sachs (Former Academic Fellow)
The Washington Post

Alzheimer’s advocacy groups on Wednesday vowed to fight a preliminary Medicare decision to restrict coverage of a controversial new drug to patients in clinical trials, a move that…

The controversial Alzheimer’s drug isn’t getting much love from Medicare image

The controversial Alzheimer’s drug isn’t getting much love from Medicare

Rachel Roubein and Alexandra Ellerbeck, featuring Rachel Sachs (Former Academic Fellow)
The Washington Post

Access restricted: Medicare is proposing to only cover the new, pricey Alzheimer’s drug for patients enrolled in certain clinical trials, a condition that would severely limit its use. …

A new Alzheimer’s drug shows why the FDA’s speedy approval process is broken image

A new Alzheimer’s drug shows why the FDA’s speedy approval process is broken

Holly Fernandez Lynch (Former Executive Director) and Christopher T. Robertson (Former Academic Fellow)
The Washington Post

Whether it’s covid or cancer, when you’re a patient facing a life-threatening disease without good treatment options, your risk tolerance is bound to be pretty high.…

Medicare must soon say whether it will cover the pricey new Alzheimer’s drug image

Medicare must soon say whether it will cover the pricey new Alzheimer’s drug

Rachel Roubein and Alexandra Ellerbeck, featuring Rachel Sachs (Former Academic Fellow)
The Washington Post

It’s a massive week for the pricey, new Alzheimer’s drug. Medicare officials are bumping up against a critical Wednesday deadline to issue a proposal on whether …

Podcast: Prescription Drug Policy, Drug Pricing & Aduhelm With Rachel Sachs image

Podcast: Prescription Drug Policy, Drug Pricing & Aduhelm With Rachel Sachs

Rachel Sachs (Former Academic Fellow) and Chris Fleming
HealthAffairs

While COVID-19 shallowed many headlines in the health care space, a lot of movement was made in various health policy areas, including prescription drug pricing. On today's episode of…

Prescription Drug Policy, 2021 And 2022: The Year In Review, And The Year Ahead image

Prescription Drug Policy, 2021 And 2022: The Year In Review, And The Year Ahead

Rachel Sachs (Former Academic Fellow)
HealthAffairs

This past year was filled with news in the prescription drug policy area, from the Food and Drug Administration’s (FDA) most controversial drug approval in many years to…

Two views of cancer medicines: Imagery versus evidence image

Two views of cancer medicines: Imagery versus evidence

Jonathan J. Darrow (Former Student Fellow)
Health Marketing Quarterly

Despite advertising imagery portraying cancer medicines as offering substantial improvement or cure, most patients can expect modest or no incremental benefit from most new treatments, according to pre-specified criteria. When…

CMS officially tosses ‘Most-Favored Nation’ drug pay model image

CMS officially tosses ‘Most-Favored Nation’ drug pay model

Maya Goldman, featuring Rachel Sachs (Former Academic Fellow)
Modern Healthcare

Who Invented Covid-19 Vaccines? Drugmakers Battle Over Patents image

Who Invented Covid-19 Vaccines? Drugmakers Battle Over Patents

Peter Loftus, featuring Jacob S. Sherkow (Former Edmond J. Safra/Petrie-Flom Centers Joint Fellow-in-Residence)
Wall Street Journal

A high-stakes legal battle is taking shape over lucrative patent rights for Covid-19 vaccines, with drug companies pitted against each other and government and academic scientists over who invented what. …

Call for Papers: 2022 Jaharis Health Law Symposium, DePaul College of Law

Deadline: January 15, 2022
Alice Setrini

The DePaul Journal of Health Care Law, Mary and Michael Jaharis Health Law Institute, and Center for Intellectual Property Law & Information Technology (CIPLIT®) are excited to…

PORTAL Fellowship, Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital Department of Medicine and Harvard Medical School

Deadline: January 28, 2022
Ameet Sarpatwari, Ph.D., J.D.

The Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital Department of Medicine and Harvard Medical School invites its 2022 round of applications for postdoctoral fellows in pharmaceutical…

Alzheimer’s experts call on FDA to pull Biogen’s Aduhelm image

Alzheimer’s experts call on FDA to pull Biogen’s Aduhelm

Zachary Brennan, featuring Rachel Sachs (Former Academic Fellow)
Endpoints News

Alzheimer’s disease researchers along with medical professors from Harvard and Johns Hopkins issued a formal statement Monday asking the FDA to quickly pull Biogen’s Aduhelm from…

Biogen Quickly Cuts Alzheimer’s Drug Cost After Payer Pushback image

Biogen Quickly Cuts Alzheimer’s Drug Cost After Payer Pushback

Angelica Peebles and John Tozzi, featuring Rachel Sachs (Former Academic Fellow)
Bloomberg

Biogen Inc. said it would cut the list price of its Alzheimer’s disease drug Aduhelm in half in the U.S., a move that comes after the treatment…

Every drug should be labelled to tell you how well it works image

Every drug should be labelled to tell you how well it works

Jonathan J. Darrow (Former Student Fellow)
Mail+

When buying over- the-counter drugs or being prescribed medication by your GP, what’s the one thing you want to know? The answer is obvious, of course: how well…

Changes in the Use of Hydroxyprogesterone Caproate Injection After Confirmatory Trial Failure image

Changes in the Use of Hydroxyprogesterone Caproate Injection After Confirmatory Trial Failure

Rachel E. Sachs (Former Academic Fellow), Kyle A. Gavulic, Julie M. Donohue
JAMA Internal Medicine

The US Food and Drug Administration (FDA) accelerated approval pathway allows new drugs with uncertain clinical benefits to be approved on the basis of clinical trials involving surrogate end points.…

Challenges in confirming drug effectiveness after early approval image

Challenges in confirming drug effectiveness after early approval

Holly Fernandez Lynch (Former Executive Director) and Christopher T. Robertson (Former Academic Fellow)
Science

It’s easy to understand the urge to make potentially beneficial drugs quickly available to patients in need. It’s also easy to go too far. Through its 2021…

Vaccines, Regulation, and Patents: A Conversation with Harvard Medical School Professor Dr. Jonathan J. Darrow image

Vaccines, Regulation, and Patents: A Conversation with Harvard Medical School Professor Dr. Jonathan J. Darrow

James R. Jolin, featuring Jonathan J. Darrow (Former Student Fellow)
Harvard Health Policy Review

HHPR Senior Editor James Jolin interviewed Jonathan Darrow, S.J.D., LL.M., J.D., M.B.A, an Assistant Professor of Medicine at Harvard Medical School and a Faculty…

Medicare Coverage of Aducanumab — Implications for State Budgets image

Medicare Coverage of Aducanumab — Implications for State Budgets

Rachel E. Sachs (Former Academic Fellow) and Nicholas Bagley
The New England Journal of Medicine

CMS is considering whether and under what circumstances Medicare will pay for aducanumab for Alzheimer’s disease. A restrictive coverage determination could save the federal government money, but it…

Let’s Make a Deal…on Drug Prices image

Let’s Make a Deal…on Drug Prices

Featuring Rachel E. Sachs (Former Academic Fellow)
Tradeoffs

Democrats are on the brink of passing a historic set of drug price reforms. How will they impact patients, insurers and the drug industry?

Regeneron, Janssen Drugs Fit Profile Targeted in Spending Bill image

Regeneron, Janssen Drugs Fit Profile Targeted in Spending Bill

Alex Ruoff, Jasmine Ye Han, and Valerie Bauman, featuring Rachel E. Sachs (Former Academic Fellow)
Bloomberg Law

The idea that drugmakers get a government-backed monopoly for a period of time to recoup their investment in new drugs and then must face competition has long been the &ldquo…

Opinion: The drug pricing deal isn’t really a victory for Dems, or a loss for PhRMA. But it could be a harbinger of change image

Opinion: The drug pricing deal isn’t really a victory for Dems, or a loss for PhRMA. But it could be a harbinger of change

Zachary Brennan, featuring Rachel E. Sachs (Former Academic Fellow)
Endpoints News

Rachel Sachs, a law professor at Washington University in St. Louis who studies drug pricing and innovation, said she didn’t think companies potentially bringing in more competition prior…

Simplify drug labelling to show benefits clearly image

Simplify drug labelling to show benefits clearly

Jonathan J. Darrow (Former Student Fellow)
Nature

Aducanumab, an Alzheimer’s disease treatment, was approved by the US Food and Drug Administration (FDA) in June this year despite a lack of robust evidence that it actually…

Moderna and U.S. at Odds Over Vaccine Patent Rights image

Moderna and U.S. at Odds Over Vaccine Patent Rights

Sheryl Gay Stolberg and Rebecca Robbins, featuring Jacob S. Sherkow (Edmond J. Safra/Petrie-Flom Centers Joint Fellow-in-Residence Alumnus)
The New York Times

Moderna’s patent application names several employees as the sole inventors of a crucial component of its coronavirus vaccine, excluding three government scientists.

Democrats are trying to cut drug costs for employers, too image

Democrats are trying to cut drug costs for employers, too

Caitlin Owens, featuring Rachel E. Sachs (Former Academic Fellow)
Axios

By the numbers: Applying inflation caps to the commercial market would generate more than $150 billion in revenue for the federal government by 2030, according to an estimate by West Health. The…

Understanding The New Drug Price Reform Deal image

Understanding The New Drug Price Reform Deal

Rachel E. Sachs (Former Academic Fellow)
HealthAffairs

Yesterday, the text of the Democratic deal on prescription drug pricing reform was released. These drug pricing reforms are intended to move forward as part of a broader reconciliation package…

Advocates express tempered optimism for Dems’ drug pricing deal image

Advocates express tempered optimism for Dems’ drug pricing deal

Peter Sullivan, featuring Rachel E. Sachs (Former Academic Fellow)
The Hill

But Rachel Sachs, a health policy expert at Washington University in St. Louis, argued that the industry would have a negative reaction regardless of the scale of the drug pricing…

Dems resurrect a scaled back plan for Medicare drug price negotiations image

Dems resurrect a scaled back plan for Medicare drug price negotiations

Zachary Brennan, featuring Jonathan Darrow (Former Student Fellow)
Endpoints News

Only a few days after President Joe Biden seemed to signal that drug pricing reforms were left for dead, Democrats are already circulating plans for a scaled-back version of what…

Problematic Interactions Between AI and Health Privacy

Nicholson Price (Former Academic Fellow)
Utah Law Review

The interaction of artificial intelligence (AI) and health privacy is a two-way street. Both directions are problematic. This Essay makes two main points. First, the advent of artificial intelligence weakens…

German Pharmaceutical Pricing: Lessons for the United States image

German Pharmaceutical Pricing: Lessons for the United States

Marc A. Rodwin and Sara Gerke (Former Research Fellow in Medicine, Artificial Intelligence, and Law)
International Journal of Health Services

To control pharmaceutical spending and improve access, the United States could adopt strategies similar to those introduced in Germany by the 2011 German Pharmaceutical Market Reorganization Act. In Germany, manufacturers sell…

PhRMA Ad Misleads on Medicare Drug Negotiation Legislation image

PhRMA Ad Misleads on Medicare Drug Negotiation Legislation

Lori Robertson, featuring Rachel Sachs (Former Academic Fellow)
FactCheck.org

Rachel Sachs, a professor at the Washington University in St. Louis’ School of Law whose expertise includes food and drug regulation, and health law, told us that CBO predicts…

Pharmaceutical Companies, Human Rights, and the Alien Tort Statute image

Pharmaceutical Companies, Human Rights, and the Alien Tort Statute

I. Glenn Cohen (Faculty Director), Tyler Giannini, and Eli Y. Adashi
Journal of Law, Medicine & Ethics

On January 3, 2019, U.S. District Judge Theodore D. Chuang of the U.S. District Court of the District of Maryland took a crucial first step in redressing one of the…

The Role of State Attorneys General in Improving Prescription Drug Affordability image

The Role of State Attorneys General in Improving Prescription Drug Affordability

Michelle M. Mello, Trish Riley, and Rachel Sachs (Former Academic Fellow)
Southern California Law Review (forthcoming)

Impact litigation initiated by state attorneys general has played an important role in advancing public health goals in contexts as diverse as tobacco control, opioids, and healthcare antitrust. State attorneys…

Health experts discuss high drug prices and potential for reform at virtual Penn event image

Health experts discuss high drug prices and potential for reform at virtual Penn event

Anushka Dasgupta, featuring Rachel Sachs (Former Academic Fellow)
The Daily Pennsylvanian

Penn’s Leonard Davis Institute of Health Economics hosted a virtual seminar in which panelists discussed high drug prices and possibilities for reform in the present political climate. The…

Pressure Mounts On USPTO To Join Drug Pricing Fight image

Pressure Mounts On USPTO To Join Drug Pricing Fight

Dani Kass, featuring Nicholson Price (Former Academic Fellow) and Rachel Sachs (Former Academic Fellow)
Law360

Law360 (September 20, 2021, 6:01 PM EDT) -- Congress, the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services have called on patent officials in the…

Picking Embryos With Best Health Odds Sparks New DNA Debate image

Picking Embryos With Best Health Odds Sparks New DNA Debate

Carey Goldberg, featuring Michelle N. Meyer
Bloomberg

Rafal Smigrodzki won’t make a big deal of it, but someday, when his toddler daughter Aurea is old enough to understand, he plans to explain that she likely…

San Diego biotech allies warn drug pricing bill stifles cures. Critics don’t buy it. image

San Diego biotech allies warn drug pricing bill stifles cures. Critics don’t buy it.

Jonathan Wosen, featuring Rachel Sachs (Former Academic Fellow)
The San Diego Union-Tribune

San Diego’s biotech industry and allies are balking at a bill that would allow Medicare to negotiate drug prices, insisting the proposal would stifle innovation even as proponents…

FDA Wants To Team Up With USPTO Over Drug Pricing image

FDA Wants To Team Up With USPTO Over Drug Pricing

Adam Lidgett, featuring Rachel Sachs (Former Academic Fellow)
Law360

Biden Drug Pricing Plan Seeks To Balance Access And Innovation image

Biden Drug Pricing Plan Seeks To Balance Access And Innovation

Rachel Sachs (Former Academic Fellow)
Health Affairs

On Thursday, Health and Human Services (HHS) Secretary Xavier Becerra publicly released the Biden Administration’s Comprehensive Plan for Addressing High Drug Prices, as directed by President Biden&rsquo…

In new remarks, Cassava Sciences’ CEO shifts defense of embattled treatment for Alzheimer’s image

In new remarks, Cassava Sciences’ CEO shifts defense of embattled treatment for Alzheimer’s

Adam Feuerstein, featuring Jacob S. Sherkow
STAT News

Cassava Sciences CEO Remi Barbier on Monday shifted his defense of the company’s embattled treatment for Alzheimer’s disease: The drug is safe, he said, therefore the…

A Snapshot of U.S. IRB Review of COVID-19 Research in the Early Pandemic image

A Snapshot of U.S. IRB Review of COVID-19 Research in the Early Pandemic

Holly A. Taylor, Kimberley Serpico Holly Fernandez Lynch (Former Executive Director), John Baumann and Emily E. Anderson
Journal of Clinical and Translational Science

Background/Objective: Along with the greater research enterprise, Institutional Review Boards (IRBs) had to quickly adapt to the COVID-19 pandemic. IRBs had to review and oversee COVID-related research, while navigating…

HHS extends Aduhelm investigation into the accelerated approval pathway, wading into a brewing controversy image

HHS extends Aduhelm investigation into the accelerated approval pathway, wading into a brewing controversy

Jason Mast, featuring Rachel Sachs (Academic Fellow Alumnus)
Endpoints News

The government investigation into how the FDA approved Aduhelm appears to point well beyond the agency’s ties with Biogen in the leadup to its approval of their controversial…

Patients Want Biogen’s Alzheimer’s Drug and Someone Has to Pay image

Patients Want Biogen’s Alzheimer’s Drug and Someone Has to Pay

John Tozzi, quoting Rachel Sachs (Academic Fellow Alumnus)
Bloomberg

Biogen has said as many as 2 million Americans might qualify for Aduhelm, though it expects fewer to actually get it. Still, if just half that many patients get it, the $57…

Patient Assistance Programs for Prescription Drugs: Charities or Kickbacks? image

Patient Assistance Programs for Prescription Drugs: Charities or Kickbacks?

Sheng Liu, Jonathan Darrow (Former Student Fellow), and Aaron Kesselheim
Journal of Health and Life Sciences Law

FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway image

FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway

Elisabeth Mahase, featuring Rachel Sachs (Academic Fellow Alumnus)
The BMJ

Criticisms of the US Food and Drug Administration’s accelerated approval process have resurfaced after the recent approval of aducanumab (Aduhelm) for dementia. Elisabeth Mahase finds that the process…

Inside Biogen’s scramble to sell Aduhelm image

Inside Biogen’s scramble to sell Aduhelm: Project 'Javelin' and pressure to ID as many patients as possible

Zachary Brennan, quoting Rachel Sachs (Academic Fellow Alumnus)
Endpoints News

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program…

Biden’s executive order includes push for drug importation, but experts question feasibility image

Biden’s executive order includes push for drug importation, but experts question feasibility

Victoria Knight, quoting Rachel Sachs (Academic Fellow Alumnus)
PolitiFact

In a May court filing, the Biden administration argued the case was pointless because it's unclear whether any drug importation plans from states were going to be approved anytime…

New Alzheimer’s drug clouds outlook for Medicare premiums next year image

New Alzheimer’s drug clouds outlook for Medicare premiums next year

Mark Miller, featuring Rachel Sachs (Former Academic Fellow)
Reuters

The decision by U.S. drug regulators last month to approve a controversial treatment for Alzheimer’s disease could fuel an unusually large increase in Medicare premiums next year,…

How everyone on Medicare could end up paying for the pricey new Alzheimer’s drug image

How everyone on Medicare could end up paying for the pricey new Alzheimer’s drug

Tami Luhby, featuring Rachel Sachs (Former Academic Fellow)
CNN Politics

The controversial new drug for Alzheimer's disease, Aduhelm, is priced at $56,000 a year for treatment -- but Alzheimer's patients won't be the only ones shouldering the cost. …

In Reversal, F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug

Rebecca Robbins and Pam Belluck
The New York Times

The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. Now it recommends that the drug be given only to those with mild symptoms.

Integrating New Effectiveness Data Into US Food and Drug Administration-Approved Drug Labeling image

Integrating New Effectiveness Data Into US Food and Drug Administration-Approved Drug Labeling

Bishal Gyawali, Jonathan J. Darrow (Former Student Fellow), and Aaron S. Kesselheim
JAMA Internal Medicine

A prescription drug’s package insert (or labeling) is a document written by the manufacturer and first approved by the US Food and Drug Administration (FDA) as part of…

New Drug Could Cost the Government as Much as It Spends on NASA image

New Drug Could Cost the Government as Much as It Spends on NASA

Josh Katz, Sarah Kliff, and Margot Sanger-Katz, featuring Rachel Sachs (Former Academic Fellow)
The New York Times

A newly approved drug to treat Alzheimer’s disease is expected to become a multibillion-dollar expense for Medicare. By one projection, spending on the drug for Medicare’s…

The Drug That Could Break American Health Care image

The Drug That Could Break American Health Care

Nicholas Bagley and Rachel Sachs (Former Academic Fellow)
The Atlantic

Earlier this week, the Food and Drug Administration overruled—to much criticism—its own scientific advisory committee and approved the Alzheimer’s treatment Aduhelm. The agency made this decision despite…

Off-Label Innovation image

Off-Label Innovation

David A. Simon (Research Fellow, Digital Home Health)
Georgia Law Review

Modern medicine faces many significant challenges. This Article is about two of them. The first is that approved drugs have many potential therapeutic uses that are never identified, investigated, or…

Retirees stuck in the middle of debate over drug-price reform image

Retirees stuck in the middle of debate over drug-price reform

Eleanor Laise, featuring Rachel Sachs (Former Academic Fellow)
MarketWatch

Dr. Jeffrey Pevnick was on the brink of retirement last year when he was diagnosed with a potentially fatal heart condition and thrown a financial curveball: The St. Louis psychiatrist…

Biogen’s Costly, Unproven Drug Feared as Health Budget Buster image

Biogen’s Costly, Unproven Drug Feared as Health Budget Buster

John Tozzi, featuring Rachel Sachs (Former Academic Fellow)
Bloomberg

The approval of Biogen Inc.’s $56,000-a-year Alzheimer’s therapy creates an unprecedented challenge for the U.S. health system: a drug that many patients may get at…

Opinion: How the FDA bent its rules for Biogen’s Alzheimer’s drug and why that’s bad for the entire biopharma industry image

Opinion: How the FDA bent its rules for Biogen’s Alzheimer’s drug and why that’s bad for the entire biopharma industry

Zachary Brennan, featuring Rachel Sachs (Former Academic Fellow)
EndPoints News

The FDA’s stunning accelerated approval for Biogen’s Alzheimer’s drug Aduhelm, with limited clinical evidence supporting the decision, will have repercussions across the entire biopharma…

By approving Biogen’s Alzheimer’s drug, the FDA is shifting its rules. That is a giant risk image

By approving Biogen’s Alzheimer’s drug, the FDA is shifting its rules. That is a giant risk

Matthew Herper, featuring Rachel Sachs (Former Academic Fellow)
Stat Plus

In order to approve a new Alzheimer’s treatment, the Food and Drug Administration is rewriting its rulebook, an enormously risky move that could accelerate the public’s…

Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial image

Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial

Sue Sutter, featuring Rachel Sachs (Former Academic Fellow)
Pink Sheet

Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA…

Drug Importation image

Drug Importation: Biden Response To PhRMA Suit Highlights Infeasibility Of Trump-Era Rule

Sarah Karlin-Smith, featuring Rachel Sachs (Former Academic Fellow)
Pink Sheet

Biden administration asks court to dismiss PhRMA’s lawsuit against Trump-era pathway for drug importation from Canada because FDA has not yet cleared any Section 804 Importation Programs (SIPs). The…

Biden Administration Signals It’s in No Rush to Allow Canadian Drug Imports image

Biden Administration Signals It’s in No Rush to Allow Canadian Drug Imports

Phil Galewitz, featuring Rachel Sachs (Former Academic Fellow)
Kaiser Health News

The Biden administration said Friday it has no timeline on whether it will allow states to import drugs from Canada, an effort that was approved under President Donald Trump as…

Few new drugs deserve expedited regulatory treatment image

Few new drugs deserve expedited regulatory treatment

Jonathan J Darrow (Affiliated Faculty)
Journal of Managed Care and Specialty Pharmacy

Safety testing of new drugs has been required since the 1938 Federal Food, Drug, and Cosmetic Act, but applications were automatically approved under that law unless the US Food and Drug…

The Rhetorical Transformations and Policy Failures of Prescription Drug Pricing Reform under the Trump Administration image

The Rhetorical Transformations and Policy Failures of Prescription Drug Pricing Reform under the Trump Administration

Rachel Sachs (Former Academic Fellow)
Journal of Health Policitcs, Policy, and Law

Throughout his four years in office, President Trump made prescription drug pricing a focus of his policy agenda. President Trump not only used strong language to criticize the pharmaceutical industry…

Reining in drug patents isn’t a silver bullet against high drug prices image

Reining in drug patents isn’t a silver bullet against high drug prices

Jacob S. Sherkow (Former Edmond J. Safra Center and Petrie-Flom Center Fellow)
STAT News

One of the top orders of business for the Biden administration is curbing drug prices. It’s a laudable goal. High drug prices are a major public health concern;…

EpiPen, Patents, and Life and Death image

EpiPen, Patents, and Life and Death

Jacob S. Sherkow (Former Edmond J. Safra Center and Petrie-Flom Center Fellow) and Patricia J. Zettler
New York University Law Review

Drug pricing disputes, while significant public health concerns, are not typically immediate life or death matters. But they may be for certain emergency medicines, medicines used for potentially lethal and…

States still can’t import drugs from Canada. Now, many are seeking to import Canadian prices. image

States still can’t import drugs from Canada. Now, many are seeking to import Canadian prices.

Lev Facher, featuring Rachel Sachs (Former Academic Fellow)
STAT News

For years, former President Trump threatened to use foreign prices as a cap for what Americans should pay for drugs. Now that he’s left office without implementing the…

Reference Pricing Clauses In US COVID-19 Contracts Leave Drug Industry Vulnerable image

Reference Pricing Clauses In US COVID-19 Contracts Leave Drug Industry Vulnerable

Sarah Karlin-Smith, featuring Rachel Sachs (Former Academic Fellow)
Pink Sheet

Innovation and price controls can coexist in the United States, COVID-19 contracts show. But drug pricing experts also acknowledge the unique circumstances of COVID-19 could make such contracts hard to…

Trump’s insulin order frozen, not scrapped, by Biden image

Trump’s insulin order frozen, not scrapped, by Biden

Marisha Goldhamer, featuring Rachel Sachs (Former Academic Fellow)
AFP Fact Check

Social media posts claim President Joe Biden overturned an executive order signed by his predecessor Donald Trump that aimed to lower insulin costs for US diabetics. This is false; Biden…

Beyond The High Prices Of Prescription Drugs: A Framework To Assess Costs, Resource Allocation, And Public Funding image

Beyond The High Prices Of Prescription Drugs: A Framework To Assess Costs, Resource Allocation, And Public Funding

Jonathan J. Darrow and Donald W. Light
Health Affairs

During the past century, an accumulation of laws, organizations, and policy mechanisms has led to increasing transfers of public funds to private drug manufacturers, straining budgets and enabling industry revenues…

F.D.A. Approves Monthly Shots to Treat H.I.V.

Apoorva Mandavilli
The New York Times

It’s what many people with H.I.V. have long awaited: monthly injections to keep the virus in check, instead of the three drugs daily they now must…

While pandemic takes top priority for Biden, experts see favorable landscape for drug pricing action in Washington image

While pandemic takes top priority for Biden, experts see favorable landscape for drug pricing action in Washington

Eric Sagonowsky, featuring Rachel Sachs (Former Academic Fellow)
Fierce Pharma

Politicians of all stripes have run on promises to lower drug prices over the years, and outgoing President Donald Trump was no different. Fast-forward four years—past several attempts…

Column: Trump utterly failed to cut drug prices. Here’s how Biden could do better. image

Column: Trump utterly failed to cut drug prices. Here’s how Biden could do better.

Michael Hiltzik, featuring Rachel Sachs (Former Academic Fellow)
Los Angeles Times

As a sort of sour welcome for the Biden administration and a final slap in the face for Donald Trump, America’s drug companies jacked up prices on hundreds…

Trump leaves behind largely unworkable drug-pricing policies image

Trump leaves behind largely unworkable drug-pricing policies

Erin Durkin, featuring Rachel Sachs (Former Academic Fellow)
National Journal

Between legal challenges and practical implementation problems, President Trump isn’t leaving much policy for the Biden team to work with. But he did shift the drug-policy conversation.