Richard Klein

Background

About Richard Klein

Internationally recognized expert on Pre-approval/Expanded Access to investitgational agents for the purpose of treatment outside of the clinical trial setting. My policy work included treatment access to unapproved medical products - called expanded access or compassionate use. Starting with treatment access to drugs to treat AIDS and associated opportunistic diseases, I participated in the development of expanded access regulations and guidance documents. I also played a leading role in the creating the FDA Expanded Access website, and streamlining the process for treatment access to investigational products, including the Form 3926 application for Individual Patient INDs, and the waiver of full-board IRB review of expanded access protocols for individual patient access. As media spokesperson on expanded access at Food and Drug Administration (FDA), I spoke on television and in print for FDA. As a recognized expert on expanded access I continue to speak at national and international conferences, and consult on the regulatory framework. During a career spanning more than forty years at the FDA, I worked in various capacities related to regulatory policy and patient engagement. While working in the Office of the Commissioner, I established the first patient engagement program with the HIV/AIDS community. This set the stage for much of FDA's patient liaison activities, including the Patient Representative Program, ensuring that patients were represented on FDA advisory committee meetings for more than 100 different diseases. The program included recruitment, training and coordination of patients who serve as members of advisory committees, providing patient perspective and input into important policy and regulatory decision-making. I developed and expanded patient-oriented pages on the FDA web site, and established electronic subscription services to keep patients and other interested parties aware of important FDA activities that affected them.