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

Call for Abstracts: 2019 Petrie-Flom Center Annual Conference: Consuming Genetics
Petrie-Flom Center, Harvard Law School

Deadline: Closed.

The call for abstracts for the 2019 annual conference is now closed. The conference agenda will be posted in late fall 2018 to the conference website. Consuming Genetics: The Ethical and Legal Considerations… 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

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

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, 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

FDA Carts Away Thousands Of Documents After Surprise Inspection Of Juul Headquarters

Kaiser Health News, October 3, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Juul has come under fire recently as more and more young people turn to e-cigarettes as an alternative to traditional… 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

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

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

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

The Apple Watch is inching toward becoming a medical device

ABC News, September 13, 2018
by Michael Liedtke, AP Technology Writer

[...] Apple CEO Tim Cook has long aimed to emphasize the health- and fitness-tracking abilities of the smartwatch. The original version featured a heart-rate sensor that fed data into fitness and workout… Read More

F.D.A. Targets Vaping, Alarmed by Teenage Use

New York Times, September 12, 2018
by Sheila Kaplan and Jan Hoffman

WASHINGTON — The Food and Drug Administration on Wednesday declared that teenage use of electronic cigarettes has reached “an epidemic proportion,” and it put makers of the most popular… 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

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

Administering Health Innovation

Cardozo Law Review, Volume 39, Issue 6 (July 2018)
by Rachel E. Sachs (Academic Fellow Alumna)

From the article: Scholars and policymakers have recently begun to focus on the role federal agencies charged with health-related missions can play in the development of innovative health technologies… 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

Drug Approval in a Learning Health System

Minnesota Law Review, Forthcoming, July 30, 2018
by W. Nicholson Price (Academic Fellow Alumnus)

From the article: 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—should… 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

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

Regulation of Stem Cell Therapy Travel

Current Stem Cell Reports, July 2018
by I. Glenn Cohen and Shelly Simana

From the abstract: Purpose of Review Stem cell therapies (hereinafter: SCT) hold tremendous promise for the treatment of a variety of diseases. Yet, alongside the medical potential, they pose significant… 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

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

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

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

Payments to Study Participants: Experts Discuss Potential Framework

RAPS, February 27, 2018
by Michael Mezher, featuring NEJM article produced as part of the Harvard Catalyst Project

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

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

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

Trump’s zeal for deregulation could gum up the FDA, experts say

STAT, December 20, 2017
by Meghana Keshavan, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: President Trump quite literally cut a stretch of red tape last week to emphasize his slash-and-burn stance on government deregulation. But what would sweeping regulatory change… 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

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

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

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

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

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

Influence, integrity, and the FDA: An ethical framework

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

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

Obamacare survives its latest threat: Bare counties

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

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

Questions About The FDA’s New Framework For Digital Health

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

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

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

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

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

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

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

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

Public Participation in Drafting of the 21st Century Cures Act

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

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

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

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

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

FDA User Fee Reauthorization Clears Hurdle In Senate With Bipartisan Support

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Promoting demand-side innovation: prizes for payers

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

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

Value-Based Pricing For Pharmaceuticals In The Trump Administration

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

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

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

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

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

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

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

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

Congress and FDA nominee heap love on ‘adaptive trials’

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

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

Scott Gottlieb: Conflicts surround Trump’s FDA pick

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

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

ICER Weekly View 03-31-17

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

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

Anthem inches closer to full Obamacare exit

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

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

Senate will vote to overturn Planned Parenthood protections

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

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

Price doesn’t satisfy Congress on appropriations

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

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

Scott Gottlieb’s FDA Commissioner Confirmation Hearing: Remarkably Unremarkable

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

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

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

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

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

(Health) Law and Order

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

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

An FDA Commissioner for the 21st Century

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

President Donald Trump has named Scott Gottlieb as his nominee to be the next commissioner of the Food and Drug Administration (FDA). As compared with some of the other people whose names were floated… Read More

Regulating Black-Box Medicine

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

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

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

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

From the article: Marathon is a member of the Pharmaceutical Research and Manufacturers of America (PhRMA), the drug industry trade group. Drug companies cannot use their usual argument of saying this… Read More

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

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

From the article: As far as what existing regulations if repealed would be considered part of the “two out” part of the EO, OMB notes, “Any existing regulatory action that imposes… Read More

E&C delays vote on drug pricing bill

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

From the article: On cost: studies have found that it usually takes a handful of generic drugscompeting for market share for prices to drop. “You usually need to get to something like three or four… Read More

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

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

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

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

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

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

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

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

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

Trump’s travel ban rattles medical residency programs

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

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

Morning View 01-31-17

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

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

Vitals

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

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

The $4,500 injection to stop heroin overdoses

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

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

Regulating Secrecy

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

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

Promoting healthcare innovation on the demand side

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

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

Federal Circuit Court Appeal Cites Rachel E. Sachs

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

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

FDA Further Explains Delay on LDT Guidance

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

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

PFC Spotlight: Faculty Affiliate Ameet Sarpatwari

The Petrie-Flom Center, January 12, 2017

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

The Oxford Handbook of U.S. Healthcare Law

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

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

The FDA Should Approve Drugs Based on Evidence, Not Emotions

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

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

Funding for Cures Bill Remains Sticking Point for Health Groups

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

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

Morning View 11-28-16: Pharmaceuticals News

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

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

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

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

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

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

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

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

Using Twitter as an Intelligence Tool: 85 Accounts Worth Following

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

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

Regulating Off-Label Promotion — A Critical Test

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

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

Drug prices: Where do we go after the Election?

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

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

Drug Pricing: Where Do We Go After the Election?

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

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

The Readout: Speaking of Drug Prices

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

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

Innovation–Innovation Tradeoffs in Drug Pricing

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

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

Generic EpiPen Will Likely Secure Profits For Mylan

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

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

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

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

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

5 reasons why no one has built a better EpiPen

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

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

Euro Drug Pricing’s Tradeoffs May Limit Appeal In US

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

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

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

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

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

Missouri law professor: Consider price controls after Epipen controversy

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

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

Mylan’s sudden plans for a generic EpiPen

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

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

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

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

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

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

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

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

The FDA is prohibited from going germline

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

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

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

Deadline: Due no later than December 2, 2016

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

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

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

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

A Trojan Horse?

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

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

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

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

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

FDA Regulations Limit Blood Donations From Gay Men

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

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

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

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

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

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

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

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

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

Deadline: May 31, 2016

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

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

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

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

Regulatory Specialist
Partners HealthCare

Deadline: June 05, 2016

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

Pediatrician for Pediatric Research Ethics
Office of Pediatric Therapeutics

Deadline: June 05, 2016

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

What’s next for opioid legislation?

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

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

Prizing Insurance: Prescription Drug Insurance as Innovation Incentive,

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

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

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

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

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

Chinese Market Offers New Life to Many Drugs

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

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

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

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

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

FDA - Food

U.S. Food and Drug Administration

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

Title 21: Food and Drugs

Code of Federal Regulations

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

FDA - Guidance and Regulation

U.S. Food and Drug Administration

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

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

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

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

Food Code

U.S. Food and Drug Administration

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

USDA - Food Safety

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

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

Foodborne Outbreaks

Centers for Disease Control

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

Food Safety

FoodSafety.gov

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

Codex Alimentarius

World Health Organization

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

Food Labeling Litigation

by Nicole E. Negowetti

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

Food and Drug Law Institute

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

Harvard Food Law and Policy Clinic

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

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

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

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

Food Safety News

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

A Tool to Help Address Key Ethical Issues in Research

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

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

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

Petrie-Flom Center, February 17, 2016

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

Food and Drug Law

Peter Hutt et al., 2013

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

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

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

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