Aaron Kesselheim is an assistant professor of medicine at Harvard Medical School in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital. He is a health policy researcher and lawyer, and his work is funded by the Greenwall Faculty Scholars Program in Bioethics and the Harvard Program in Therapeutic Science. He runs the Program On Regulation, Therapeutics, And Law (PORTAL), an interdisciplinary center that engages in research and training on how laws and regulations influence the development, use, and affordability of prescription drugs and medical devices, as well as ethical questions these issues raise for patients, physicians, policymakers, and payors. The goal of PORTAL is to evaluate what policies and practices best promote effective, safe, and equitable health care delivery. He is also a primary care internist.


Recent Posts by Aaron Kesselheim

The Future Of Precision Medicine: Great Promise, Significant Challenges

Central to the PMI is the All of Us Research Program, which aims to enroll 1 million or more volunteers throughout the United States. If successful, it would be one of the largest longitudinal cohorts ever developed in this country.

Why ‘Government Patent Use’ To Lower Drug Costs Won’t Stifle Innovation

Recent commentaries express concern about the impact of our proposal that the federal government consider using an existing law to negotiate or compel lower drug prices. We believe that the impact on innovation in fact would be minimal, and the results for society highly positive.

Four Ways To Address The Ethical Tensions Around Expedited Approval Of New Prescription Drugs

The FDA and Congress have established several programs that allow new drug approval based on less evidence, so that patients and their physicians have faster access. However, expedited development and regulatory approval pathways for prescription drugs at FDA present ethical and policy dilemmas.

Addressing Generic Drug Unaffordability And Shortages By Globalizing The Market For Old Drugs

Meaningful intellectual property ownership for older medications expired decades ago, and they are now subject to massive price increases or severe shortages. This need not be the case, and there are remedies to address these problems.

The Daraprim Price Hike And A Role For Antitrust

The unfairness of a 5,000 percent price increase for the drug Daraprim has received attention. We believe the U.S. Department of Justice, Federal Trade Commission, state attorneys general, and private parties should review Turing’s behavior and consider bringing an antitrust case to challenge...

To Spur Medical Innovation, Make Corporate Cheaters Pay

The past decade has seen a relatively constant rate of newly approved drugs every year. The number has even jumped in the past few years. Yet, despite such encouraging trends, we are actually facing a crisis in drug innovation today.

Ensuring Timely Approval Of Generic Drugs

Having saved US consumers over $1.5 trillion in the past decade, generic drugs are one of the most cost-effective interventions in our entire health care system. Using generic drugs instead of brand-name drugs, when a generic is available, has been shown to increase medication adherence and...

The Short-Term And Long-Term Outlook Of Drug Coupons

In the October 2014 Health Affairs article, “Specialty Drug Coupons Lower Out-Of-Pocket Costs And May Improve Adherence At The Risk Of Increasing Premiums,” Catherine Starner and coauthors explore the relationship between drug coupons and specialty drugs. Specialty drugs, primarily injectables...

The Role Of Black Box Warnings In Safe Prescribing Practices

In the Health Affairs article, “Era of Faster Drug Approval Has Also Seen Increased Black-Box Warnings and Market Withdrawals,” published in the August issue, Cassie Frank and coauthors compare the number of approved prescription drugs that received black-box warnings or were withdrawn from the...

New Drug And Device Approval: What Is Sufficient Evidence?

Editor's note: In addition to Jonathan Darrow, this post is also coauthored by Aaron Kesselheim.  The federal Food, Drug, and Cosmetic Act gives the Food and Drug Administration (FDA) the authority to evaluate all prescription drugs and high-risk medical devices before they can be marketed...