Sarina Schrager, MD, MS; George E. MacKinnon III, PhD, MS, RPh
Published online April 2, 2022
The WMJ is introducing a new section to the journal: WMJ Pharmacotherapy Update. The updates will be published quarterly and aim to provide detailed information about current, cutting-edge topics in the pharmacy world. It is challenging to keep informed of new developments in medications and their uses. Whether that be new approvals, new indications for existing medications, controversies surrounding the use of specific treatments, new guidelines and monitoring related to various agents or general issues that affect clinical practice as related to pharmacotherapy. The updates will be evidence-based, and all authors will complete a disclosure of potential conflict of interest to minimize any bias.
In 2021 alone, the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 50 new drugs, either as new molecular entities under New Drug Applications (NDA) or as new therapeutic biologics under Biologics License Applications (BLA). CDER has averaged 43 approvals per year over the past 10 years (410 approvals over the last decade), so attempting to keep updated on new approvals alone is daunting for many practicing clinicians.1 The FDA has been in the news a lot over the last two years, and these updates may help clinicians get some insight into how new drugs are approved.2
The WMJ has a goal of being multidisciplinary, so including pharmacist colleagues to the ranks of authors, peer reviewers, and editors is a logical step.
To launch the inaugural Pharmacotherapy Update, two faculty from the Medical College of Wisconsin School of Pharmacy have led this effort and will continue to serve as authors and reviewers for this section:
- Kristin Busse, PharmD, BCPS, Assistant Professor, Administration and Regulatory Sciences, MCW Research Oversight Program Director
- Abir T. El-Alfy, PhD, Associate Professor, Pharmacology, Assistant Dean of Student Affairs
We look forward to collaborating with faculty from the University of Wisconsin-Madison School of Pharmacy in the future as well.
We hope you enjoy this new series and welcome your feedback. Email wmj@med.wisc.edu.
References
- Pal S. Recent trends in approval of novel drugs. US Pharm. 2021;46(10):14.
- National Institutes of Health. How are drugs approved for use in the United States? Accessed February 8, 2022. https://www.nichd.nih.gov/health/topics/pharma/conditioninfo/approval