Carey Business School Professor on Expanded Access to Drugs

Michael Presley graduated with honors from Shepard Broad College of Law at Nova Southeastern University in 1980 and has maintained active membership with the Florida State Bar ever since. He serves as a partner and an attorney with his two sons at the law firm of Presley & Presley, PA, and the CEO and chief risk officer of United MSO of America, LLC. Michael Presley recently enrolled in the MBA program at The Johns Hopkins Carey Business School (JHUCarey) with the aim of better serving his clients in health care administration.
JHUCarey recently reported on a paper published by Assistant Professor Stacey Lee and Alexandra Murata exploring the legal side of expanded access to drugs undergoing clinical trials. As the proverbial last-ditch effort, patients with terminal illnesses may wish to have access to these drugs before they receive FDA approval. In many cases, a patient’s physician will request access to the drug from the company that produces it. While some companies agree, many do not. The companies are not required to permit access or give any reason for their denial.
Some public cases of patients wishing for access to these potentially lifesaving drugs have led to several states implementing a law called Right to Try, which can override FDA regulations, but, unfortunately, not the decisions of the drug companies. Dr. Lee’s paper, published in the Journal of Business Ethics, argues for improved guidelines for making such requests from the drug companies, ensuring that patients understand the potential risks of taking a drug that has not been approved for use. Drug company websites should have easy-to-find information for people wanting to make a request, and if the companies deny a request, they should be required to provide their reasons in writing so the family can at least understand why they are being denied expanded access.
