From the New England Journal of Medicine. By Alfred B. Engelberg, JD; Jerry Avorn, MD; Aaron S. Kesselheim, MD, JD, MPH. SUMMARY: This NEJM Perspective identifies two underused federal legal tools that could significantly reduce drug costs without new legislation. The first is the government's statutory right to a royalty-free license to use any patented invention that was discovered using federal funding — a provision already embedded in existing law but rarely invoked. The

From the New England Journal of Medicine. By William B. Feldman, MD, DPhil, MPH; Benjamin N. Rome, MD; Jerry Avorn, MD; Aaron S. Kesselheim, MD, JD, MPH. SUMMARY: This NEJM Perspective reviews a federal "Transparency in Coverage" rule requiring health insurers to disclose both list prices and historical net prices for medications and to provide patients with personalized cost-sharing estimates before they fill prescriptions. Feldman, Rome, Avorn, and Kesselheim examine the ru

From the New England Journal of Medicine. By Jerry Avorn, MD; Aaron S. Kesselheim, MD, JD, MPH; Ameet Sarpatwari, JD, PhD. SUMMARY: This NEJM Perspective by Avorn, Kesselheim, and Sarpatwari evaluates the FDA Amendments Act of 2007 (FDAAA) a decade after its enactment. The authors open by situating the FDAAA within the long history of US drug regulation, which has been shaped by crises: Progressive-era concerns about patent medicines led to the 1906 Pure Food and Drug Act; th

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 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 and Aaron S. Kesselheim, MD, JD, MPH. SUMMARY: This NEJM Perspective by Avorn and Kesselheim offers a critical analysis of the 21st Century Cures Act, then under active congressional debate. The authors argue that the legislation, despite its forward-looking name, would effectively lower FDA approval standards by authorizing the agency to rely on observational data and other forms of real-world evidence in place of

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

From Health Affairs. By Jerry Avorn, MD. SUMMARY: This Health Affairs editorial introduction by Dr. Avorn opens a thematic issue devoted to the relationship between prescription drugs and the elderly population. Avorn, identified as one of very few academically affiliated physicians specializing in this area, provides an overview of the issue's scope, which spans geriatric drug development, elderly participation in clinical trials, pharmaceutical pricing, drug utilization pat