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

By Ameet SarpatwariCharlie LeeFrazer 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 pharmaceutical law and policy.

Below are the abstracts/summaries for papers identified from the month of April. The selections feature topics ranging from increases in Internet searches for hydroxychloroquine following promotional remarks by the President, to an evaluation of health gains from orphan drugs, to an assessment of clinical trials supporting new FDA drug approvals. A full posting of abstracts/summaries of these articles can be found on our website.

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Stacks of books against a burgundy wall

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.

Below are the abstracts/summaries for papers identified from the month of March. The selections feature topics ranging from the utilization and cost of naloxone for patients at high risk of opioid overdose, to off-label and compassionate drug use in the COVID-19 pandemic, to public-sector financial support and sponsorship for gene therapy trials in the U.S. A full posting of abstracts/summaries of these articles may be found on our website.

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Photograph of a stack of magazines on a chair

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

By Ameet Sarpatwari, 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 June. The selections feature topics ranging from premarket development times for biologics versus small-molecule drugs, to the characteristics of trials and regulatory pathways leading to U.S. approval of innovative vs. non-innovative drugs, to generic and brand-name thyroid hormone drug use among commercially insured and Medicaid beneficiaries. A full posting of abstracts/summaries of these articles may be found on our website.

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Abstract representation of DNA double helix

Gene Editing and Intellectual Property: A Useful Mix?

The Health Policy and Bioethics Consortia is a monthly series that convenes two international experts from different fields or vantage points to discuss how biomedical innovation and health care delivery are affected by various ethical norms, laws, and regulations.

They are organized by the Harvard Medical School Center for Bioethics and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital, in collaboration with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Support provided by the Oswald DeN. Cammann Fund at Harvard University.

A light lunch will be provided. This event is free and open to the public, but space is limited and registration is required. Please note that attendees will need to show ID in order to enter the venue. Register now!

 

One way of thinking about genome editing is through the lens of the legal and ethical obligations of ensuring the technology is deployed safely and accurately, for the betterment of human society.

Or, if that’s a mouthful for you, genome editing’s rights—and wrongs. Which brings me to a talk I’ll* be giving at Harvard Medical School on March 8: “Genome Editing: Rights and Wrongs” I feel obligated, however, to asterisk the personal pronoun (“I”) because, in truth, what I’ll be doing is sharing the stage with one the world’s most celebrated scientists, George Church, world-renowned bioethicist, Jeantine Lunshof, and moderated by health policy guru, Aaron Kesselheim. Read More

close up of human eye

The Luxturna Debate: Why Ethics Needs a Seat at the Drug Pricing Table

By Clio Sophia Koller

Jack Hogan can now ride his bike home at dusk after an afternoon of playing with his friends. Is that childhood rite-of-passage worth $850,000?

Recently, the Health Policy and Bioethics Consortium convened by Harvard Medical School’s Center for Bioethics and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital met to discuss the implications of Spark Therapeutics’ new gene therapy treatment—along with its staggering price tag.

Luxturna, a novel therapy approved by the FDA last year, treats a rare form of inherited blindness known as retinitis pigmentosa. The therapeutic agent targets the RPE65 gene, associated with the disorder, and is shown to improve vision in a population with progressive vision-loss and an inability to see in dim light. Read More