Unbiased Analysis of Today's Healthcare Issues
An interesting paper from Kevin Chiu in the Journal of Health Economics looks at the relationship between certificate of need laws and health outcomes: Certificate of need (CON) regulations requires that health care providers obtain state approval before offering a new service or expanding existing facilities. The purported goal of CON regulations is to reduce…
Recently, the Food and Drug Administration (FDA) approved Prograf (tacrolimus) in combination with other immunosuppressant drugs for the new indication of preventing organ rejection for patients who have received a lung transplant. While the FDA approving a new indication isn’t typically news, this is a noteworthy event because (i) it marks the first approval of…
The answer to this question likely will be shaped in part by a new multilateral working group that will include not only representatives from the U.S. (U.S. Department of Justice Antitrust Division, and Offices of State Attorneys General), but also Canada (Canadian Competition Bureau), Europe (the European Commission Directorate General for Competition) and the United…
Diversity in clinical trials Recently, the FDA’s Center for Drug Evaluation and Research’s (CDER’s) released its 2020 Drug Trials Snapshots Summary Report. Part of the report examines the demographics of participants in clinical trials for the 53 drugs that FDA approved in 2020 either as new molecular entities (NMEs) under new drug applications (NDAs) or…
How do you evaluate treatment efficacy and safety outside of the clinical trial setting? This is not just a question of academic interest. In last week’s JAMA, Rubin 2021 writes about some of the challenges of evaluating COVID-19 vaccines outside of a clinical trial setting. In an interesting, two-day workshop last week, the Duke Margolis…
The FDA approval process is slow. Even for COVID-19 vaccines, the process can be time consuming. However, regulators around the world do have some expedited programs. However, a number of countries have programs that expedite review, particularly for the diseases with unmet need, orphan drugs, or when new treatments represent a significant advance over the…
This is the question that a recent paper by Chorniy et al. (2020) attempt to answer. This issue is clearly very relevant as the UK recently has approved the Pfizer/BioNTech vaccine for COVID-19 before the US. Unlike most studies that attempt to examine the relationship between FDA review time and R&D investment dollars, the authors…
Given the incredible speed in which vaccine development for COVID-19 is occurring, it merits thinking back on the typical development and approval time of previous vaccines. Puthumana et al. (2020) reviews 21 vaccines approvals since 2010. They find that: …most novel vaccines approved by the FDA required about 8 years of clinical development and were…
The 21st Century Cures Act required the Food and Drug Administration (FDA) establish a program for evaluating the use of real-world data (RWD) to support the approval of new indications for drugs. Real-world data is typically data from either health insurance claims, electronic health records (EHRs), patient registries, or mobile devices. But how has FDA…
From Cahan, Kocher, and Bohn in the Health Affairs blog: Since passage of the 2010 “Biosimilars” Act aimed at stimulating non-inferior innovation and competition in therapeutics markets, only 17 agents have been approved, and only seven have made it to market. Why haven’t biosimilars been more attractive? Blackstone et al. (2013) cites 3 key issues:…