pills

What Does It Mean That Oracle is Partnering with the Trump Administration to Study Unproven COVID-19 Drugs?

Cross-posted from Written Description, where it originally appeared on March 30, 2020. 

By Lisa Larrimore OuelletteNicholson PriceRachel Sachs, and Jacob Sherkow

One of the dizzying stream of innovation and health law stories to emerge last week is Oracle’s partnership with the White House to study unproven pharmaceuticals for treating COVID-19. We decided to unpack this story for ourselves and then to collectively share our thoughts in a short explainer.

Click here to read the full post at Written Description.

graphic of pen pointing at data chart

Seife v. HHS: A Decade of Missing Trial Data

By Phebe Hong

Data is knowledge, and knowledge is power. Thanks to a recent court ruling, more medical data may soon be available to the public. A Southern District New York federal judge ruled this week that the FDA and NIH had been misinterpreting a law requiring clinical trial sponsors to release data. The ruling clarifies that reporting requirements – previously applied only to trials completed after 2017 – actually applies to trials completed since 2007. As a result, many pharmaceutical companies, biotechs, universities, and other institutions will have to provide previously unpublished data (or risk non-compliance).

The ruling of Seife v. HHS has been broadly summarized by STAT, Endpoint News, and Science Magazine. Here, we take a closer detailed look at the court’s legal opinion and reasoning:

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gavel on top of a pile of bills and pills

A Local City Takes on Pharma

By Phebe Hong

A city northwest of Atlanta is taking on Big Pharma. On February 6th, the city of Marietta filed a lawsuit in federal court in Atlanta against Mallinckrodt, a global specialty pharmaceutical company. The class action complaint alleges that Mallinckrodt is “unjustly enriched” by its “exorbitant and unconscionable prices” for Acthar, a therapeutic adrenocorticotropic hormone (ACTH) approved in 1952 and indicated for various disease conditions, most notably infantile spasms and multiple sclerosis relapse. Marietta brings the class action suit on behalf of itself and “[a]ll third-party payors and their beneficiaries and people without insurance” that have paid for Acthar in the past four years.

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A calculator, a stethoscope, and a stack of money rest on a table.

Why Our Health Care Is Incomplete: Review of “Exposed” (Part II)

By: Daniel Aaron

Just last month, Professor Christopher T. Robertson, at the University of Arizona College of Law, released his new book about health care, entitled Exposed: Why Our Health Insurance Is Incomplete and What Can Be Done About It. Part II of this book review offers an analytical discussion of “cost exposure,” the main subject of his book with a focus on solutions. Read Part I here.

Baby solutions

Prof. Robertson writes two chapters on solutions. In the first, titled “Fixes We Could Try,” he offers reforms, from mild to moderate, that would make cost exposure less harmful. The chapter largely retains the analytical nature of the prior chapters, but it comes across like a chapter he might have rather not written. This is evident in the following chapter’s title, “What We Must Do.” It’s also evident because some of the proposals do not seem fully considered, and in some ways appear more controversial than the more comprehensive solution offered later. Read More

A calculator, a stethoscope, and a stack of money rest on a table.

Why Our Health Care Is Incomplete: Review of “Exposed” (Part I)

By: Daniel Aaron

Just last month, Professor Christopher T. Robertson, at the University of Arizona College of Law, released his new book about health care, entitled Exposed: Why Our Health Insurance Is Incomplete and What Can Be Done About It. This book review will offer an analytical discussion of “cost exposure,” the main subject of his book.

What is cost exposure in health care?

Cost exposure is payments people make related to their medical care. There are many ways patients pay – here are a few common ones.

  • Deductible – Patient is responsible for the first, say, $5,000 of their medical care; after this point, the health insurance kicks in. Resets each year.
  • Copay – Patient pays a specific amount, say $25, when having an episode of care.
  • Coinsurance – Patient pays a specified percentage, say 20%, of care.

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Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.

The Rise of Biosimilars: Success of the BPCIA? (Part III)

By Jonathan Darrow

This is Part III in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines.  Part III considers a path forward in the regulation of biologics.  For Part I, click here.  For Part II click here.

A Path Forward

The small number of biosimilar approvals compared to generic drug approvals cannot establish the failure of the BPCIA due to differences in industry familiarity with each follow-on pathway, the number of reference products available for copying, patient population sizes, patent barriers, and drug costs. The later arrival of US laws and guidance documents—not inadequate legal design—is the most straightforward explanation of why the first US biosimilar approvals were delayed compared to those in Europe.

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Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.

The Rise of Biosimilars: Success of the BPCIA? (Part II)

By Jonathan Darrow

This is Part II in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines.  Part II covers some key considerations and factors that impact the biologics market and regulation.  For Part I, click here.

Reference Products Available for Copying in 1984

Because most post-1962 drugs enjoyed a 17-year patent term (changed to 20 years in 1995), there was little need for an abbreviated pathway in the years immediately following the Kefauver-Harris Amendments. But as patents expired, increasing numbers of post-1962 drugs became available for copying yet were ineligible as reference products under the 1970 ANDA regulations. On the eve of the Hatch-Waxman Act, Congress estimated that approximately 150 post-1962 drugs were off-patent but had no generic equivalent. This backlog of available reference products produced a surge in ANDA approvals following enactment of the new law (Exhibit 1).

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Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.

The Rise of Biosimilars: Success of the BPCIA? (Part I)

By Jonathan Darrow

This is Part I in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already-approved biological medicines.  This Part briefly covers the history of American regulation of biologics and touches briefly on the European experience.

The Biologics Price Competition and Innovation Act (BPCIA), part of the 2010 Affordable Care Act, sought to drive down prices for biologics, much as the 1984 Hatch-Waxman Act did for small-molecule drugs. By allowing manufacturers of follow-on products to rely in part on the clinical data of the brand-name reference product, both laws were designed to lower development costs and attract competitors.

Since the BPCIA’s enactment, however, scholars have compared it unfavorably to the Hatch-Waxman Act, criticized its pathway as “obstructed” and lacking in sufficient incentives, lamented the scarce approvals it has produced, and recommended that it be “abandoned.” Although criticisms of the law are not without basis, their collective implication—that the BPCIA is irredeemably defective and will never yield robust competition—may be wrong.

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close up of an open book

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of December. The selections feature topics ranging from potential Medicare savings on inhaler prescriptions through use of negotiated prices and a defined formulary, to evaluation of the REMS for extended-release/long-acting opioids, to the costs of medication non-adherence in adults with atherosclerotic cardiovascular disease in the US. A full posting of abstracts/summaries of these articles may be found on our website. Read More

Illustration of four people helping each other climb progressively taller stacks of books

What’s Missing From Biotech Graduate Education? With Free Course, RA Capital Attempts to Fill the Gaps

By Jessica Sagers

As a PhD student in the life sciences at Harvard, I attended almost every career seminar that came through my inbox. I had no idea what I wanted to do after finishing my research doctorate, but I was certain that it wasn’t more cell culture.

The walls of my academic bubble were so thick that even as a budding cell biologist, I’d managed to hear almost nothing about Boston’s booming biotech industry. “Going into industry” was regarded as an “alternative career,” to the point where it sounded like taking a job outside of academia was tantamount to abandoning science. Besides, all my training had been in basic science. The coursework I’d excelled in, from neurobiology to biophysics, did not equip me to translate what I’d learned to the business world.

During my final PhD year, curiosity about the biotech sector drove me to accept an internship at RA Capital Management, a life science-focused investment firm in Boston. Dr. Peter Kolchinsky (Harvard Program in Virology, ’01), Founder and Managing Partner of RA Capital, brought me and a group of fellow PhD students on board to help achieve his vision of providing more pragmatic, focused training to scientists and professionals interested in working in biotechnology. Together, we designed a short, advanced course on the business of biotech designed to fit the practical needs of late-stage graduate students and early-career professionals.

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