Blood glucose monitor and insulin.

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

By Ameet Sarpatwari, Alexander Egilman, andAaron 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 June. The selections feature topics ranging from a review of modifications to blood glucose monitoring systems and related patent protections, an examination of insulin price changes from 2012-2019, and a discussion of why a proposed federal bill that would ban government health care programs from using the quality-adjusted life-year is misguided. A full posting of abstracts/summaries of these articles may be found on our website.

Read More

EU flags in front of European Commission in Brussels.

European Union Debates Further Patent Protections

By Sarah Gabriele

In line with the European Union’s efforts to strengthen the single market and as part of the Single Market Strategy presented by the European Commission in 2015, the European Commission has presented a proposed regulation regarding the Unitary Supplementary Protection Certificate (“USPC”). The proposed regulation will extend patent protections across the Union, creating a stronger right for brand-name pharmaceutical companies. However, the proposed regulation, in line with the most recent case law of the European Court of Justice, further strengthens the limit for pharmaceutical companies to obtain only one certificate per product per patent holder.

Read More

Pharmacist with a prescription looking at a medicine box on a pharmacy shelf.

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

By Ameet Sarpatwari, Liam Bendicksen, 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 May. The selections feature topics ranging from an investigation of federal support for the development of expensive HIV drugs, to an analysis of COPD exacerbations and hospitalizations among new users of maintenance inhalers, to a comparison of sales for new drugs with and without an initial orphan drug designation. A full posting of abstracts/summaries of these articles may be found on our website.

Read More

white pills spilling out of orange plastic pill bottle onto hundred dollar bills.

Merck Price Negotiation Lawsuit May Face Same Obstacles as 340B Takings Claims

By Laura Dolbow

Merck recently filed a lawsuit that challenges the constitutionality of the Medicare price negotiation program created by the Inflation Reduction Act. Under this program, HHS will select a small number of single source drugs for price negotiation. Merck alleges that the price negotiation program operates as a price control because it effectively requires manufacturers to accept the maximum fair price as a condition of participation in Medicare and Medicaid. Merck argues that this form of price regulation charts a “radical new course” for Medicare that violates the Takings Clause of the Fifth Amendment.

But the price negotiation program is not the first time that Congress has placed a restriction on the prices that Medicare program participants can charge. And Merck’s lawsuit is not the first suit that has alleged that such price regulations are unconstitutional takings. Drug manufacturers recently made similar claims in litigation involving the 340B Drug Pricing Program. Two district courts rejected those claims, highlighting several obstacles that Merck’s takings claim may face as well.

Read More

Silver Spring, MD, USA - June 25, 2022: The U.S. Department of Health and Human Services (HHS), U.S. Public Health Service (USPHS) and FDA logos are seen at the FDA headquarters, the White Oak Campus.

FDA Solicits Feedback on the Use of AI and Machine Learning in Drug Development

By Matthew Chun

The U.S. Food and Drug Administration (FDA), in fulfilling its task of ensuring that drugs are safe and effective, has recently turned its attention to the growing use of artificial intelligence (AI) and machine learning (ML) in drug development. On May 10, FDA published a discussion paper on this topic and requested feedback “to enhance mutual learning and to establish a dialogue with FDA stakeholders” and to “help inform the regulatory landscape in this area.” In this blog post, I will summarize the main themes of the discussion paper, highlighting areas where FDA seems particularly concerned, and detailing how interested parties can engage with the agency on these issues.

Read More

an ambulance parked at the entrance of an emergency department

Psychiatric Care in Crisis

By Zainab Ahmed

Psychiatric care in the Emergency Department is all-or-nothing and never enough. Often, legal holds are the only intervention available, and they rarely are therapeutic. Upon discharge, our patients are, once again, on their own.

The ED acts as a safety-net for a failing health system, one that places little value on mental health services, either preventative or follow-up. The demand for acute psychiatric care is high; however, EDs have little physical capacity for psychiatric patients.

Read More

Magazines on wooden table on bright background.

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

By Ameet Sarpatwari, Aviva Wang, andAaron 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 April. The selections feature topics ranging from an analysis of government and industry investments for recently approved drugs, to a discussion of court decisions on mifepristone, and an examination of the added therapeutic benefit associated with the top-selling brand-name drugs in Medicare.

A full posting of abstracts/summaries of these articles may be found on our website.

Read More