Medical Regulation

How FDA Drug Review Contributed to the Opioid Epidemic

Scholars argue that FDA should use larger health data sets in its approval process for high-risk drugs.

Proposed Rule Aims to Make Drug Pricing More Transparent

A proposed requirement to display drug list prices in advertisements draws controversy.

Regulatory Collaboration Is Key to Public Health Success

Federal health agencies should work together to address public health problems.

Invoking a Right to Try in Regenerative Medicine

Scholars caution against using the Right to Try Act to skirt regulation for regenerative therapies.

FDA Reform Needs to Look More Like Tax Reform

U.S. regulators should model the medical device classification process on recent tax reform.

How Regulation Can Improve Surgery

Scholar argues that agencies should collect evidence on surgical procedures to help implement best practices.

Gene Editing of Human Embryos Prompts Calls For Regulation

Despite ethical concerns, scholar argues that gene editing of human embryos should not be banned.

Improving Federal Regulation of Medical Algorithms

Scholar argues that FDA should reform its regulation of algorithm-based medicine.

Addressing the International Legal Challenges of Genetic Engineering

In keynote address, Gary Marchant discusses the transnational implications of genetic engineering.

How Much of an Income Drop Will Take a Life?

Policymakers should consider the impact of their decisions on not just wealth, but also human life.

How FDA Should Use Its Authority to Regulate Human Cells

FDA should encourage states to be the primary regulators of stem cell procedures.

Challenges in Measuring Regulatory Capture

Regulatory capture, neither inevitable nor a death trap for agencies, must be reduced to advance public policy goals.