From the New England Journal of Medicine. By Michael Fralick, MD; Jerry Avorn, MD; Aaron S. Kesselheim, MD, JD, MPH. SUMMARY: This NEJM Perspective examines drug importation from Canada as a potential mechanism for increasing competition and reducing the cost of essential medications in the United States. Fralick, Avorn, and Kesselheim review the state of drug importation policy, including a recently proposed bill addressing the safety of Canadian drugs, and assess both the p

From the New England Journal of Medicine. By Chana A. Sacks, MD; Jerry Avorn, MD; Aaron S. Kesselheim, MD, JD, MPH. SUMMARY: This NEJM Perspective by Sacks, Avorn, and Kesselheim examines the case of solanezumab, a monoclonal antibody developed for Alzheimer's disease that failed to demonstrate meaningful clinical benefit in trials. The authors argue that the FDA's rejection of the drug — despite significant industry and patient-advocate pressure to approve it — served the pu

From JAMA. By Aaron S. Kesselheim; Jerry Avorn, MD; Ameet Sarpatwari, JD, PhD. Importance: The increasing cost of prescription drugs in the United States has become a source of concern for patients, prescribers, payers, and policy makers. Objectives: To review the origins and effects of high drug prices in the US market and to consider policy options that could contain the cost of prescription drugs. Evidence: We reviewed the peer-reviewed medical and health policy literatur

From the New England Journal of Medicine. By Jerry Avorn, MD. SUMMARY: In this NEJM Perspective, Dr. Avorn critically examines a widely cited claim by an industry-supported research center that it costs pharmaceutical companies $2.6 billion to develop a new drug. Avorn identifies significant methodological concerns with this estimate, including its reliance on industry-provided data, its inclusion of the opportunity cost of capital as an actual cost, and its failure to accoun

From the New England Journal of Medicine. By Ameet Sarpatwari, JD, PhD; Jerry Avorn, MD; Aaron S. Kesselheim, MD, JD, MPH. SUMMARY: This NEJM Perspective evaluates the early progress of the biosimilar approval pathway created by the 2010 Biologics Price Competition and Innovation Act (BPCIA). Sarpatwari, Avorn, and Kesselheim mark the FDA's first biosimilar approval — filgrastim-sndz — as a milestone, while identifying the significant legal, regulatory, and market obstacles t

From HealthAffairs. By Aaron S. Kesselheim, Yongtian Tina Tan, and Jerry Avorn. Abstract Transformative drugs, defined as pharmaceuticals that are both innovative and have groundbreaking effects on patient care, are the “holy grail” of drug research and development. The sources of drug innovation are often debated, with pharmaceutical manufacturers arguing that high drug prices support innovative output from their sector. We studied the developmental histories of twenty-six d

From the New England Journal of Medicine. By Aaron S. Kesselheim, MD, JD, MPH; Jerry Avorn, MD; Jeremy A. Greene, MD, PhD. SUMMARY: This NEJM Perspective by Kesselheim, Avorn, and Greene examines the legal and regulatory framework governing generic drug safety, with particular focus on the question of who bears responsibility when a generic drug causes harm. The piece engages the then-contested legal question of whether generic manufacturers could be held liable for inadequat

From the New England Journal of Medicine. By Alfred B. Engelberg, JD; Aaron S. Kesselheim, MD, JD, MPH; Jerry Avorn, MD. SUMMARY: This NEJM Perspective by Engelberg, Kesselheim, and Avorn examines the debate over how long biologic drugs should enjoy market exclusivity before biosimilar competition is permitted — a policy decision then being shaped by the 2009-2010 health care reform process. The authors use the Hatch-Waxman Act's track record for small-molecule generic drugs

From the New England Journal of Medicine. By Jerry Avorn, MD. SUMMARY: In this NEJM Perspective written shortly after the January 2006 launch of Medicare Part D, Dr. Avorn characterizes the new benefit's implementation as chaotic and harmful to vulnerable patients. Drawing on Kaiser Family Foundation survey data, he documents widespread problems with the benefit's rollout, including pharmacy errors, coverage gaps, formulary confusion, and particular hardship for elderly patie