One pill on mint green background.

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

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, 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.

Below are the citations for papers identified from the month of December. The selections feature topics ranging from a discussion of the challenges in confirming drug effectiveness after early approval, to an analysis of potential savings from a proposed policy requiring manufacturers of drugs receiving accelerated approval to pay higher rebates to Medicaid until efficacy is demonstrated, to an evaluation of the racial and ethnic representation in clinical trials supporting FDA approval of new drugs and biologics. A full posting of abstracts/summaries of these articles may be found on our website.

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Suboxone.

Eliminating Barriers to Opioid Use Disorder Treatment

By Jennifer D. Oliva, Taleed El-Sabawi, and Shelly Weizman

The tragedy of the ever-worsening drug poisoning and overdose crisis in the United States is compounded by a simple fact: We know how to prevent overdose deaths, and yet, the overwhelming majority of individuals with opioid use disorder (OUD) lack access to the lifesaving, standard of care treatment.

Research demonstrates that the opioid agonist medications methadone and buprenorphine are the safest and most effective treatments for OUD. As the National Academy of Sciences explained in a 2019 report, these two medications reduce risk of death by up to 50 percent and are associated with numerous other benefits, including improved quality of life, reduced rates of use of other opioids, and reduced risk of contracting illnesses including HIV and hepatitis C.

However, during the worst drug poisoning crisis in U.S. history, which is now killing more than 100,000 people a year, the country’s outdated and restrictive federal regulatory schemes that pertain to methadone and buprenorphine present a pernicious and persistent barrier to accessing OUD medications.

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Mushrooms containing psilocybin grow in the forest.

Washington Psilocybin Bill Would Legalize Supported Adult Use

By Mason Marks

On Tuesday, Washington State legislators filed SB 5660, a bill that would legalize the supported adult use of psilocybin by people 21 years of age and older.

Sponsored by Senators Jesse Salomon and Liz Lovelett, the bill, known as the Washington Psilocybin Wellness and Opportunity Act, includes many innovative features including a Social Opportunity Program to help address harms caused by the war on drugs, a provision to support small businesses, and accommodations for people with certain medical conditions to receive the psychedelic substance at home.

I had the privilege of helping to draft the Washington Psilocybin Services Wellness and Opportunity Act with input from the Psychedelic Medicine Alliance of Washington and my colleague John Rapp of the law firm Harris Bricken. We had previously collaborated on the psychedelic decriminalization resolution adopted unanimously by the Seattle City Council.

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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, Beatrice Brown, Aviva Wang, 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.

Below are the citations for papers identified from the month of November. The selections feature topics ranging from an analysis of cost-effectiveness studies of oncology drugs approved between 2015 and 2020, to payer-specific negotiated prices for prescription drugs at top-performing US hospitals, to an assessment of access to COVID-19 vaccines in countries where they were tested.

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Vial and syringe.

Addressing IP Barriers in the Context of a Pandemic Treaty

This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Paul Ogendi

Tackling the question of how to address the needs for sharing scientific research, pooling technology, and know-how in diagnostics, therapeutics, and potential vaccines in future epidemics is fundamental to any pandemic treaty discussion. Moreover, we also need to consider how such a treaty might address potential conflicts with the Trade Related Intellectual Property Rights (TRIPS) agreement.

First of all, market-based solutions do not work in the context of global pandemics as has been demonstrated in the COVID-19 pandemic that is currently ravaging the world. Market-based solutions demand putting too much faith in the private sector, both in terms of capacity (supply chains, etc.) and in terms of equity. By relying on the private sector in the context of COVID-19, many countries are struggling to secure adequate personal protective equipment, testing kits, and more importantly life-saving vaccines.

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Gloved hand grabs beaker with rolled currency.

Leverage COVID-19 Frameworks to Prepare for the Next Pandemic

By Matthew Bauer

How should scientists, policy makers, and governments balance efforts to address the current pandemic with initiatives to prevent the next one?

We have seen this play out before during the 2003 SARS crisis. A burst of research funding and resources were thrown at tackling the health emergency that spread to 29 different countries. Ultimately, enormous efforts across the globe were able to halt the crisis, but as scientific research continued post-outbreak, it became difficult to sustain funding.

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A male pharmacist is examining a drug from a pharmacy inventory.

HHS’ New Prescription Drug and Health Care Spending Rule

By Cathy Zhang

Today, the Department of Health and Human Services — alongside the Department of Labor, the Department of the Treasury, and the Office of Personnel Management — published an interim final rule requiring health insurance plans and issuers on the marketplace to report data on prescription drug and health care spending to the three Departments.

This rule is part of a series of rules issued by the Biden Administration to implement Title I (No Surprises Act) and Title II (Transparency) of the Consolidated Appropriations Act, 2021.

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Colorful magazines.

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

By Ameet SarpatwariBeatrice Brown, Alexander Egilman, 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.

Below are the citations for papers identified from the month of October. The selections feature topics ranging from a discussion of policies for reducing disparities in access to prescription drugs, to an analysis of patient and payer incentives to use brand-name drugs vs. their authorized generics in Medicare Part D, to an evaluation of trends in revenue generated from cancer medicines among major pharmaceutical companies from 2010 to 2019. A full posting of abstracts/summaries of these articles may be found on our website.

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Blister pack of pills, but instead of bills dollar bills are rolled up in the packaging

What Democrats’ Drug Pricing Plan Means for Consumers

By Cathy Zhang

At the start of the month, Democrats announced a new drug pricing plan, detailed in the House’s Build Back Better Act (H.R. 5376). In the immediate short term, the drug pricing plan has enabled the $1.75 trillion bill to go forward through the House. If ultimately enacted, it will generate savings for consumers, some more directly than others, and at a more modest pace and magnitude than many had hoped.

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Concept: An ounce of prevention is worth a pound of cure.

The Paradoxical Legal Treatment of Preventive Medicine

By Doron Dorfman

Preventive medicine is a tool used by individual patients, primary care physicians, and governmental agencies to preempt illnesses rather than to treat them after they have arisen. Despite this salubrious aim, stigma, shame, and fear often are attached to the use of preventative care.

The stigma around preventive medicine can arise from the tendency to view such measures as a proxy for risky or otherwise socially marginalized behavior or lifestyle. Why would someone use a preventative measure if they are not at high risk as a consequence of their own choices?

Consider, for example, what I call “sexually charged” preventative health measures like the human papillomavirus vaccine or Pre-Exposure Prophylaxis (PrEP). PrEP is a highly effective daily drug regimen that prevents HIV infection, which has become specifically popular with gay and bisexual men.

As I discuss in a forthcoming paper, PrEP has been viewed by policymakers and health care professionals as a “license for promiscuity” due to the fear of risk compensation, meaning the adjustment of risky behavior by those who take PrEP to potentially have sex with more partners and with no condoms. Such views are reflected in Kelley v. Becerra, a case pending before the U.S. District Court of the Northern District of Texas, where plaintiffs wish to purchase insurance that excludes coverage for PrEP and contraception, to which they object to on religious and moral grounds.

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