If there was one theme that was pervasive throughout the discussions and presentations at the recent AAM Access 2024 meeting in Tampa, Florida, it was related to drug shortages. The issue was touched upon by representatives from AAM, officials from the FDA, CEOs, Doug Long of IQVIA, and others as well. With different individuals providing their perspectives and presenting information on the subject, there was some divergence in the data that was presented and some eye-opening observations including:

• Of current drug shortages in the FDA’s database, approximately 25% were first placed on the list prior to 2020; and
• The oldest unresolved shortage was first reported in 2012 (yes, a dozen years ago).

At this point in the year, FDA staff is feverishly compiling the information for the FDA’s annual report to Congress on drug shortages, which should be published within the next few months; the 2022 report was posted on the Drug Shortages webpage on June 7, 2023.  While these reports are required of the FDA and are necessary for establishing a record of these issues over time, it does beg the following questions: How many annual reports to Congress does the FDA need to issue?  How bad does the problem need to become for Congress to take action? The FDA is clearly limited in what it can do to assist in eradicating drug shortages, but the issue keeps falling to the FDA and industry to solve.

All stakeholders seem to acknowledge that the primary issues here are economic in nature, and there were two particularly salient points raised during the discussions at the AAM meeting that drove that point home. One CEO stated that approximately half of his company’s drug portfolio doesn’t make a profit but the company still supplies these drugs out of a sense of altruism and concern for public health, while another pointed out that a full 56% of the drugs that are in shortage cost less than $1 per unit. 

On Wednesday, February 7, during the AAM Chair’s address, Keren Haruvi, President, Sandoz North America, introduced an individual in attendance, Laura Bray, who founded Angels for Change in 2019 after her daughter experienced difficulties in obtaining medications to treat her leukemia. This reminded me of a similar situation that transpired seven or eight years earlier when the women’s basketball coach for the University of Maryland, Brenda Frese, also encountered problems procuring medications for treatment of one of her children, who was also in need of a chemotherapeutic agent. My final question is: How many more patients and parents need to experience this situation? Maybe next year’s Access meeting should take place on Capitol Hill!

---

Martin H. Shimer, II, RPH, is an Executive Director at Lachman Consultants with over 20 years of experience at the U.S. FDA. While Deputy Director of the Division of Legal and Regulatory Support at the FDA, Mr. Shimer was responsible for implementation of new statutory requirements and resolving complex issues (legal, scientific and/or regulatory) impacting ANDAs. He has extensive experience in ANDA review for regulatory and legal compliance. Mr. Shimer was a negotiator for the GDUFA II program and has conducted presentations on various aspects of the generic program for other governmental agencies, DIA, AAM, Congressional staff and many divisions with FDA. He has also received multiple commendations for his work with the FDA, including the Commissioner’s Special Citation, numerous other FDA Recognition Awards and the FDLI Distinguished Service and Leadership Award.