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

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

A patent ploy

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

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

Ohio’s Drug-Pricing Ballot Question Triggers Voter Confusion

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

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

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

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

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

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

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

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

Allergan ruling casts doubt on tribal patent strategy

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

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

Judge invalidates Allergan patents and criticizes deal with the Mohawks

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

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

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

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

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

Ohio Issue 2 ballot initiative proponents overstate impact on EpiPen prices

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

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

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

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

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

Mobile Health Innovation and Interagency Coordination

Annals of Health Law, Vol. 26, Issue 22
by Rachel E. Sachs (Academic Fellow Alumna)

From the paper: An app that can tell when a phone’s owner is having a seizure.1 A device that transforms a phone into a mobile EKG machine.2 An app that helps patients track their moles over time—and… 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

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

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

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

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

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

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

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

What you missed while following Charlottesville: The opioid emergency

Axios, August 18, 2017
by Erica Pandey, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: The opioid emergency "The opioid crisis is an emergency, and I'm saying officially, right now, it is an emergency ... It's a national emergency. We're going to spend a lot… Read More

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

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

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

Bernie Sanders Tells Big Pharma

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

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

Administering Health Innovation

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

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

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

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

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

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

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

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

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

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

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

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

Book Review: I Contain Multitudes - The Microbes Within us and a Grander View of Life

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

From the review by Rachel E. Sachs: Ed Yong's I Contain Multitudes: The Microbes Within us and a Grander View of Life is a thoughtful, readable, and even humorous look at the rapidly evolving… Read More

Trying to Keep up with the Health Care Debate on the Hill? Follow These Folks on Twitter

STAT News, June 13, 2017
by Megha Satyanarayana, featuring Rachel E. Sachs (Academic Fellow Alumna)

From the article: The GOP effort to repeal and replace Obamacare is picking up steam again as the Senate works on its bill behind closed doors. How to keep track of it all? Here are a few folks to follow on… Read More

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

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

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

Q&A with Faculty Scholar Rachel Sachs

Institute for Public Health at Washington University , May 23, 2017
by Interview featuring Rachel Sachs (Academic Fellow Alumna)

From the interview: Rachel Sachs, associate professor, School of Law, is a scholar of innovation policy whose work explores the interaction of intellectual property law, food and drug regulation,… Read More

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

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

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

Legal Roundtable: Discussing abortion restrictions, health care, Supreme Court developments and more

St. Louis Public Radio, May 30, 2017
by Kelly Moffitt, featuring Rachel Sachs (Academic Fellow Alumna)

From the radio episode: On Tuesday’s St. Louis on the Air, Legal Roundtable panel returned to discuss pressing issues of the law. They discussed a number of topics, starting with national issues… 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

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

FiercePharma, March 21, 2017
by Tracy Staton, citing blog post by Rachel E. Sachs (Academic Fellow Alumna)

From the article: [...]Amgen has caught fire for its aggressive stance on its PCSK9 patents, which also protect its own drug in the class, Repatha. Market watchers note that a similar patent fight—Merck… Read More

Maryland Goes a Step Further to Rein in Drug Price Spikes

Regulatory Affairs Professionals Society (RAPS), February 27, 2017
by Zachary Brennan, citing Rachel E. Sachs (Academic Fellow Alumna)

[...] The bill has drawn criticism from industry groups and others who say such independent audits would be overly burdensome for industry and that the $2500 threshold might include too many drugs… Read More

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

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

This article is behind a paywall. Read More

Express Scripts CEO addresses drug pricing ‘misinformation’

St. Louis Post-Dispatch, February 17, 2017
by Samantha Liss, quoting Rachel E. Sachs (Academic Fellow Alumna)

[...] Typically, after dispensing drugs to patients, a drug manufacturer will write Express Scripts a rebate check. That timing can expose some patients, especially those with high deductibles, to the… Read More

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

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

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

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

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

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

Could Amgen’s Patent Victory Be Bad For Medicine?

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

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

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

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

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

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

Prop 61: Californians appear to say no to lowering drug costs

STAT News, November 9, 2016
by Rebecca Robbins, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Rachel Sachs, a law professor who studies health policy at Washington University in St. Louis, cautioned against interpreting the ballot measure’s failure as a public repudiation… Read More

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

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

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

Drug prices: Where do we go after the Election?

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

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

Drug Pricing: Where Do We Go After the Election?

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

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

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

EpiPen Maker Quietly Steers Effort That Could Protect Its Price

New York Times, September 16, 2016
by Eric Lipton and Rachel Abrams, quoting Rachel E. Sachs (Academic Fellow Alumnus)

[...] The idea being advanced is simple: If the EpiPen makes the federal preventive list, most Americans would have no insurance co-pay when getting the product. That means they could obtain… 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

Behind the EpiPen controversy are questions about patents granted to drugmaker

St. Louis Post-Dispatch, September 4, 2016
by Samantha Liss, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: [...] Usually, insurance carriers decide if the update is meaningful. If the update is minimal and there are other competitors, usually the insurance carrier favors the other product.… 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

Endpoints News Early Edition

Endpoints News, August 31, 2016
by John Carroll, featuring blog post by Rachel E. Sachs (Academic Fellow alumna)

From the email: Don't miss this commentary from Harvard's Rachel Sachs:  I am not shocked by Mylan’s actions here, and it is arguably not even the worst offender in the game of jacking… Read More

Mylan’s Lower-Cost EpiPen May Not Hurt Drugmaker’s Sales Much

Bloomberg, August 29, 2016
by Cynthia Koons and Zachary Tracer, quoting Rachel E. Sachs (Academic Fellow alumna)

[...] Meanwhile, by introducing its generic, Mylan will set the market price for subsequent competitors. “Now that there’s a product on the market for $300, any generic that enters knows… 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

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

Social Media & Health Law

The Week in Health Law Podcast, Episode 58, June 5, 2016
by By Nicolas Terry & Frank Pasquale, featuring Rachel E. Sachs (Academic Fellow), Ed Silverman, Ross Silverman and Nicholas Bagley

Fresh from ASLME's Health Law Professors' Conference in Boston: a special TWIHL! Pharmalot's Ed Silverman joins a cavalcade of past show guests (Rachel Sachs, Ross Silverman,… Read More

Health Insurance as Innovation Incentive

Jotwell, June 9, 2016
by Amy Monahan, reviewing paper by Rachel E. Sachs (Academic Fellow)

Excerpt from the article: In Prizing Insurance: Prescription Drug Insurance as Innovation Incentive, Rachel Sachs brings together the often disparate worlds of intellectual property theory and health insurance… 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

Petrie-Flom, 10 years on:

Harvard Law Today, April 14, 2016

On March 29, current and former affiliates of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics were joined by Harvard Law School's Dean Martha Minow and several prominent… Read More

CRISPR, Are We Ready to Rewrite the Human Genome?

ECUSA Boston, March 24, 2016
by Speaker: Rachel Sachs (Academic Fellow)

Rachel Sachs (Academic Fellow) was a speaker at the ECUSA Boston event "CRISPR, Are We Ready to Rewrite the Human Genome?" on March 24, 2016. The gene editing tool CRISPR has revolutionized… 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

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

Does it break the law to charge a lot for a cure?

The Incidental Economist Blog, January 28, 2016
by Nicolas Bagley, quoting Rachel E. Sachs (Academic Fellow)

From the article: [...] Talk about sending the wrong signals about what sorts of drugs we value most. As Rachel Sachs wrote in an email: In my view, Sovaldi is a drug that shouldn’t exist… Read More

Big Pharma, the game, makes it “easy to be villainous”

STAT, November 11, 2015
by Ike Swetlitz, referencing Rachel Sachs (Academic Fellow)

Excerpt from Article: [...] While Wicksteed made the game for the general public, the scientific and medical community is also starting to take note. The Lancet reviewed Big Pharma in October,… Read More

Translational Microbiome Workshop: Patent Law and Microbiome-Based Technologies

MIT Center for Microbiome Informatics and Therapeutics, November 6, 2015
by Rachel Sachs (Academic Fellow)

 Researchers from OpenBiome, the first and largest public stool bank, and the MIT Center for Microbiome Informatics and Therapeutics organized a workshop with over 60 members of Boston’s clinical… Read More

FDA’s Pathway for Regulation of Fecal Microbiota Transplants

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

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

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

Written Description Blog, July 27, 2015
by Lisa Ouellette

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

PAPER NOW AVAILABLE

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

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

Countdown to Cures

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

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

New Review of Academic Fellow Rachel Sachs on Fecal Transplants

The Incidental Economist, June 1, 2015
by Nicholas Bagley

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

The Future of Personalized Medicine

Hosted by The Future Society at the Harvard Kennedy School, January 28, 2015
by Rachel E. Sachs

On January 28, 2015, Academic Fellow Rachel E. Sachs spoke to the Future Society at the Harvard Kennedy School of Government on "The Future of Personalized Medicine." The talk addressed a range of… Read More

Academic Fellow Rachel Sachs Guest Lecturing in Reading Group at Harvard Law School

Petrie-Flom Center, January 22, 2015

Petrie-Flom Academic Fellow Rachel E. Sachs will be a regular guest lecturer in a reading group at Harvard Law School, co-taught by with Professors Terry Fisher and Mark Wu in Spring 2015,… Read More

The New Model of Interest Group Representation in Patent Law

Yale Journal of Law and Technology, October 1, 2014
by Rachel Sachs (Academic Fellow)

From the article: Traditional public choice theory postulates that interest group representation is primarily responsible for the passage of legislation in a variety of areas. Intellectual property scholars… Read More

Welcome 2014-2016 Academic Fellow Rachel Sachs!

Petrie-Flom Center, April 17, 2014

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