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

The Promise and Pitfalls of Trump’s “Most Favored Nation” Approach to Drug Pricing

By Vrushab Gowda

On September 13th, President Trump issued an executive order aimed at addressing ballooning pharmaceutical expenditures.

The order seeks to apply a “most favored nation” scheme to prescription drug payments made through Medicare Parts B and D, which are currently on track to exceed $130 billion. Although ambitious in scope, the order’s ultimate impact remains to be seen.

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Suboxone.

Obstacles and Advances to Accessing Medication for Opioid Use Disorder

By Marissa Schwartz

Medication for Opioid Use Disorder (MOUD), sometimes referred to as Medication-Assisted Treatment (MAT), is a life-saving, evidence-based treatment method considered the gold standard for addressing opioid use disorders. Unfortunately, however, there are a number of barriers — both legal and cultural — that prevent some patients from accessing the treatment they need.

MOUD combines the use of prescription medications (like buprenorphine, methadone, and naltrexone) with counseling and behavioral therapies to provide comprehensive treatment in an inpatient or outpatient setting.

Due to stigma toward MOUD from patients and providers, as well as an overall lack of providers certified to dispense MOUD, there are currently more prescribing rules in the U.S. for the drugs used in MOUD, like buprenorphine, than for opioids. Major legal barriers include provider limits on the number of patients to whom they can offer MOUD, restrictions on which facilities can provide in-patient MOUD treatment, and insurance pre-authorization requirements.

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Large pile of amber prescription pill bottles

How Policy Surveillance Might Help to Counter the Opioid Epidemic

By Erin Napoleon

In 2017, more than 47,000 people had died of an opioid overdose, and 2 million people were dependent on opioids. This astonishing number is attributable in part to the lack of federal and state legislation to curb the over-prescription of opioids.

Opioids first entered the US market in the late 1990s. Pharmaceutical companies’ assured physicians that opioids were less addictive than morphine and posed less dangerous side effects, and doctors began prescribing the pills at unprecedented rates.

Understanding how the dearth of federal and state legislation, coupled with prescribing patterns based on race and socioeconomic status, influence the over-prescription of opioids can potentially lead to new and innovative ways of solving the opioid epidemic that continuously threatens the United States.

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Syringe and vials of vaccine.

How Does Moderna’s COVID-19 Vaccine Work, and Who Is Funding Its Development?

Cross-posted from Written Description, where it originally appeared on August 19, 2020. 

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

Moderna, Inc., a Cambridge, MA-based biotech company, is a leading contender in the race to develop a SARS-CoV-2 vaccine. Moderna’s vaccine, however, works using a completely novel mechanism, unlike any other vaccine currently approved anywhere in the world. Despite this, the U.S. government—and two agencies in particular, the NIH and Biomedical Advanced Research and Development Authority (BARDA)—has invested, heavily, in the vaccine’s development. This week, we explore how these investments interact through different forms of research partnerships, and what this says about IP, novel technologies, and innovation policy.

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Large pile of amber prescription pill bottles

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

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) go through recent, 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 July. The selections feature topics ranging from an assessment of excess prescription drug spending associated with delayed generic competition, to an analysis of the differences between the use of advisories by drug regulatory bodies in various countries, to a commentary on the pitfalls of using SSR Health data for estimating net prescription drug spending. A full posting of abstracts/summaries of these articles may be found on our website.

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a pile of vaccine vials and a needle

COVID-19 Vaccine Advance Purchases Explained

Cross-posted from Written Description, where it originally appeared on August 5, 2020. 

By Nicholson PriceRachel SachsJacob S. Sherkow, and Lisa Larrimore Ouellette

No vaccine for the novel coronavirus has been approved anywhere. Nevertheless, governments and international organizations around the world are announcing deals for billions of dollars to procure tens of millions of doses of vaccines from companies that are still running clinical trials, including a $2.1 billion deal with Sanofi and GSK announced by the US on Friday. What’s going on? And what do these deals tell us about innovation policy for COVID-19 vaccines? In this post, we lay out the landscape of COVID-19 vaccine pre-purchases; we then turn to the innovation impact of these commitments, and finish by asking what role patents and compulsory licensing have to play.
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NHS building

First Do No Harm: The Independent Medicines and Medical Devices Safety Review

By John Tingle

A new hard-hitting report on medicines and medical device safety published in the U.K. presents controversial proposals that have the potential to improve National Health Service (NHS) patient safety.

The report, The Independent Medicines and Medical Devices Safety Review, was published on July 8th, 2020 after a two year investigation chaired by Baroness Julia Cumberlege. The review investigated two medications — Primodos and sodium valproate — and one medical device — pelvic mesh.

The reviews remit was to examine how the healthcare system in England responded to reports about harmful side effects from medicines and medical devices and how best to respond in the future.

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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 dollar bill, with a bottle of pills nearby

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

By Ameet Sarpatwari, Charlie Lee, 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 June. The selections feature topics ranging from the cost of delayed generic entry in Medicaid, to challenges with false negative tests for SARS-CoV-2 infection, to difficulties in implementing and enforcing state opioid prescribing laws. A full posting of abstracts/summaries of these articles may be found on our website.

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