Close-up Of Doctor's Hand Measuring Blood Pressure Of Male Patient.

Understanding the Role of Race in Health: A New Digital Symposium

By Craig Konnoth

In the 1980s, a vanguard of critical race theorists debated their contemporaries as to whether law could or should play a role in achieving equity — in particular, racial equity. Scholars such as Kimberlé Crenshaw and Patricia Williams argued that while legal discourse historically had been used to oppress Black, Indigenous, and people of color (BIPOC), history had shown that in the law also lay the seeds of empowerment. Conceptualizing BIPOC as persons endowed with legal rights, and as a community subject to heightened legal solicitude because of the historical injustices they have faced, has helped undergird their selfhood, dignity, identity and activism. Law could thus be a discourse of despair — but also one of hope.

Whether or not the years have proved those claims correct as to the law, today, a similar debate unfolds in the context of race, medicine, and health care. Today, medicine and the health care system embody discourses of power that rival the law. Will these discourses inevitably serve to oppress BIPOC — and if not, how can we harness their power to achieve justice? Those are the questions that this symposium seeks to answer.

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Dried psilocybe cubensis psilocybin magic mushrooms inside a plastic prescription medicine bottle isolated on white background.

As Cities Decriminalize Psychedelics, Law Enforcement Should Step Back

By Mason Marks

Amid rising rates of depression, suicide, and substance use disorders, drug makers have scaled back investment in mental health research. Psychedelics may fill the growing need for innovative psychiatric drugs, but federal prohibition prevents people from accessing their benefits. Nevertheless, some cities, dissatisfied with the U.S. war on drugs, are decriminalizing psychedelics.

In 2019, Denver became the first U.S. city to decriminalize mushrooms containing psilocybin, a psychedelic the FDA considers a breakthrough therapy for major depressive disorder (MDD) and treatment-resistant depression.

In a historic vote, Denver residents approved Ordinance 301, which made prosecuting adults who possess psilocybin-containing mushrooms for personal use the city’s “lowest law enforcement priority.” Since then, in Oakland and Santa Cruz, California, voters approved their own decriminalization measures.

As a Schedule I controlled substance, psilocybin remains illegal under federal law, and despite ongoing clinical trials, it is unlikely to become FDA approved for several years. Social distancing requirements due to COVID-19 are disrupting medical research causing further delays. But as the November election approaches, other U.S. cities prepare to vote on psychedelics.

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A stethoscope tied around a pile of cash, with a pill bottle nearby. The pill bottle has cash and pills inside.

What Ever Happened to NIH’s “Fair Pricing” Clause?

By Jorge L. Contreras

In the midst of the COVID-19 pandemic, calls have been made for “fair” and “reasonable” pricing of the vaccines and therapeutics that will eventually be approved to address the virus. A range of proposals in this regard have been made by members of Congress, the Trump Administration, various states, academics and civil society.

Amid this current debate, it is worth remembering the brief period from 1989 to 1995 when the U.S. National Institutes of Health (NIH) did impose reasonable pricing constraints on drugs that were developed as part of cooperative R&D agreements (“CRADAs”) between federal agencies and private industry.

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Washington, DC, USA -- March 4, 2020. Wide angle photo of a throng of protesters at an abortion rights rally in front of the Supreme Court.

June Medical v. Russo Reflects Ongoing Struggle with Black Women’s Constitutional Equality

By Michele Goodwin

The Supreme Court’s June Medical v. Russo case was more than just another cog in the wheel of the intensifying battle against the constitutional right to terminate a pregnancy.

Though, on its face, the case was about access to abortion, just beneath the surface, the law at issue represented a continuation of Louisiana’s historic resistance to sex and race equality. Read More

view of Chicago

What Two Neighborhoods in Chicago Show About Disparities During COVID-19

By Michael Atalla

Minorities, especially African-Americans in metropolitan areas, are being infected with and dying from COVID-19 at higher rates than their white counterparts.

This phenomenon is occurring in many large cities like New York, Detroit, and New Orleans. This piece focuses on Chicago — arguably the most segregated city in all of America. Comparing two zip codes within Chicago city limits with similar population sizes but divergent racial composition, the disparities are striking.

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cruise ship

Old and New Ways of Coping with COVID-19: Ethics Matters (Part I)

By Leslie Francis and Margaret Pabst Battin

This post is part I of a two-part series on pandemic control strategies in response to COVID-19.

Your life and the lives of many others may depend now on isolation, quarantine, cordon sanitaire, shelter in place, or physical distancing.

These terms have entered the public consciousness rapidly. Though general awareness has increased, the important practical and ethical differences between these practices require further explanation.

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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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Ambassador-at-Large Deborah Birx giving a speech from a podium with an American flag and PEPFAR banner in the background

One of the Biggest Public Health Initiatives in History: PEPFAR and HIV

By Daniel Aaron

In October, the Petrie-Flom Center hosted a conference of world-leading experts in HIV/AIDS to discuss one of the biggest public health successes in history: PEPFAR, the President’s Emergency Plan for AIDS Relief. PEPFAR was launched in 2003 in response to a burgeoning global epidemic of HIV. The program offered $2 billion annually, rising to about $7 billion in 2019, to surveil, diagnose, treat, and reduce transmission of HIV around the world.

PEPFAR prevented what could have become an exponentially growing epidemic. It is estimated to have saved more than 17 million lives and avoided millions of new HIV infections. As a result, the speakers at the conference were quick to extol the virtues of the program. Professor Ashish Jha called it an “unmitigated success”; Professor Marc C. Elliott named it a “historic effort”; Dr. Ingrid Katz described PEPFAR as “nothing short of miraculous.”

However, several undercurrents within the conference, as well as more explicit points made by several panelists, suggested the importance of enlarging the discussion beyond PEPFAR itself to include other policies that impact HIV and AIDS, and even other diseases.

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