Pile of colorful pills in blister packs

The Age of Orphans

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By Sarah Rickwood

The 2020s are the age of orphan medicines.

Orphan medicines are available for a larger number of diseases and patients than ever before, a testament to the success of legislation established decades ago encouraging the development of these medicines in both the U.S. and European Union.

Orphan medicines were the majority of European Medicines Agency (EMA) approvals for the first time ever in 2016 (59%) and the majority of U.S. Food and Drug Administration (FDA) approvals for the first time ever in 2018 (58%).

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person cuts salami sausage on a wooden cutting board.

Tackling Salami Slicing and Indication Stacking in Orphan Drug Innovation Incentives

Join the author on Friday, September 17, 2021 for the 2021 CeBIL Symposium. Register here!

By Sven Bostyn

The development of orphan drugs, so named for the rare diseases they treat, has been incentivized through regulation in the European Union. The primary reward is 10 years’ market protection (or exclusivity).

But are these incentive mechanisms working as they should? To date, only 131 orphan drugs have been brought to market. Findings from the European Commission’s long-awaited evaluation of the orphan drug system in Europe, 20 years after its inception, suggest there may be cause for concern.

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

Mortal Sins of Orphan Drug Development: How to Save the Lost Souls

Join the authors on Friday, September 17, 2021 for the 2021 CeBIL Symposium. Register here!

By Jakob Wested and John Liddicoat

In a working paper from November 2020, the EU Commission finds a significant inefficiency in the EU orphan drug regulation (a pan-EU piece of legislation): that it does not contain a provision to safeguard the affordability and accessibility of orphan medicines.

The working paper then entertains the idea of inserting such a provision into the regulation. But, is the orphan drug regulation the right place for this type of law?

Diagnosing the problem behind orphan drug pricing is the key issue to address before jumping to consider ways to address excessive pricing.

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A range of contraceptive methods: DMPA, vaginal ring, IUD, emergency contraceptive, contraceptive pills.

Connecting the Dots: Reproductive Justice + Research Justice = Health Justice

By Monica R. McLemore

I believe that together, reproductive justice and research justice should result in health justice.

I am choosing to focus on research because it is the evidence base that is foundational to clinical care provision and because teaching is generated by research.

Thus, research serves as one root cause of harm associated with clinical care and teaching, and a potential barrier to realizing health justice, which has been outlined as a comprehensive approach to resolve the social determinants of health and develop jurisprudence toward health equity. Research justice is critical to the conceptualization, development and implementation of these measures.

However, the law cannot establish health justice without reproductive justice, at least not for pregnant-capable people. Reproductive health, rights, and justice have been the proverbial canaries in the coal mine when considering the loss of bodily autonomy and human rights.

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Beverly Hills, CA: April 7, 2021: Anti-mask protesters holding signs related to COVID-19. Beverly Hills and the state of California have a mask mandate requirement.

What Makes Social Movements ‘Healthy’?

By Wendy E. Parmet

Social movements can play an important role in promoting population health and reducing health disparities. Yet, their impact need not be salutatory, as is evident by the worrying success that the anti-vaccination movement has had in stoking fears about COVID-19 vaccines.

So, what makes a health-related social movement “healthy?” We need far more research about the complex dynamics and interactions between social movements and health, but the experience of a few health-related social movements offers some clues.

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mask

COVID-19 is Still a Crisis for All

By Chloe Reichel

Recently, a narrative that COVID-19 is now a “pandemic of the unvaccinated” has emerged.

Setting aside the callousness of the claim, the biggest problem with this narrative is that it’s wrong. COVID-19 continues to threaten the health and well-being of all, regardless of vaccination status.

As we now know, vaccinated individuals can be infected with and transmit the delta variant. “Breakthrough” infections are not rare — countries with better data collection efforts than the U.S., including Israel and the United Kingdom, estimate vaccine efficacy against infection by the delta variant at around 40-50%.

This isn’t to say that the vaccines are worthless. We should continue to work to promote vaccine uptake, as the vaccines do provide a level of protection against the most severe outcomes.

But we need to understand: We can’t end this pandemic with vaccines alone.

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Home innovation technology concept illustration.

Call for Abstracts — 2022 Petrie-Flom Center Annual Conference: Diagnosing in the Home

Contribute to the 2022 Petrie-Flom Center Annual Conference and subsequent book project!

Through October 14, 2021, the Petrie-Flom Center is accepting abstracts for its annual conference. The 2022 annual conference will focus on ethical, legal, and regulatory challenges and opportunities around at home digital health technology.

This conference will engage with the vision for a 21st century health care system that embraces the potential of at home digital products to support diagnoses, improve care, encourage caregivers, maximize pandemic resilience, and allow individuals to stay within the home when preferable. The goals of this conference and subsequent book project are to consider the ethical, sociological, regulatory, and legal challenges and opportunities presented by the implementation of digital products that support clinical diagnosis and/or treatment in patients’ homes over the next decade.

Interested in submitting an abstract, but want to know more about what we’re looking for? Read through the following frequently asked questions.

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a pill in place of a model globe

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) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on pharmaceutical policy.

Below are the citations for papers identified from the month of March. The selections feature topics ranging from a commentary on the evidence base for the Alzheimer’s drug aducanumab (which is currently under FDA review), to a comparative study of drug pricing in the U.S. and France, to a study of the demographic characteristics of participants in vaccine trials leading to FDA approval. A full posting of abstracts/summaries of these articles may be found on our website.

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