The consultancy provides Regulatory & Scientific (R&S) advice to pharmaceutical companies to assist in the development of Over-the-Counter (OTC) and Prescription (Rx) drug products. Occasionally, the consultancy provides expert witness support for worthwhile legal cases of merit.Prior to starting the consulting company, I worked at the FDA for 15 years. The last 8 of those years I was the Director of the Division of Nonprescription Clinical Evaluation. More about the FDA work can be found below. The consultancy assists clients in many ways such as:-Advising on "Rx to OTC switch" & Direct-to-OTC development programs-Analysis of the OTC "switch-ability" of prescription drugs-Providing input on need for & protocol designs for Label Comprehension, Self Selection, Human Factor, & Actual Use Studies-Regulatory & Scientific input on drug development programs (incl conditions of safe use) & the Nonprescription Safe Use Regulatory Expansion (NSURE) initiative-Providing R &S Input on OTC Monograph products-Reviewing, drafting, and providing feedback on Rx and OTC Meeting Requests & Background Packages -Providing R & S Review of Rx & OTC PIND, IND (including IND amendments), NDA, and sNDA submissions -Providing R & S assessment of proposed Rx & OTC drug development programs (including regulatory strategy and design of clinical trials) in all phases of drug development -Reviewing and developing OTC and Rx Labeling-Providing R & S Input on 505(b)(2) applications (incl NDA deviations)-Providing R & S Assessment of Pediatric Study Plans and Proposed Pediatric Study Requests -Assisting with Dispute Resolution submissions-Advisory Committee meetings preparation-Advice on and Interpretation of Regulatory Requirements, Guidelines, Guidance documents, Meeting Minutes, & Advice Letters-Providing R & S Review of Patient Reported Outcome Instruments -Providing Clinical Guidance in Internal Medicine, Rheumatology and Pain Management

Board Certified Internist and RheumatologistCare of pain patients and patients with other medical problems arising from psychological stress. Teach George Washington University Medical Center students and residents. Associate Clinical Professor, George Washington University School of Medicine and Health Sciences

At FDA 15 years (1998 - 2013) working on new OTC switch drugs and OTC monograph drugs - Division Director for 8 years. Directed the Division review & evaluation of over-the-counter (OTC) drug research and applications, including safety, effectiveness, consumer data, and labeling that could lead to switching a prescription product OTC. Signatory authority on letters for drug approvals, complete responses, & letters advising investigators of results of FDA’s review of their clinical protocols. Determined if animal & human trials were designed to support safety, effectiveness, & proposed labeling for an OTC product. Developed novel solutions to respond to labeling issues addressing safety in adults and children. Work with FDA’s Office of Compliance on misbranding of OTC drug products.Evaluated scientific data related to OTC drug monograph products Considered risks and benefits for OTC use of drug products that treat or otherwise impact dermatologic, gastrointestinal, pulmonary, allergy, analgesic, addictive drug (nicotine), urologic, metabolic, reproductive, viral & other infectious disease conditions & more. Advised FDA leadership regarding planning, development, formulation, implementation, execution, administration, and coordination of activities which affect policies, programs % goals involving the OTC drugs. Initiated, organized & ran Advisory Committee meetings so outside experts could advise on controversial OTC drug issues. Represented the FDA to external constituents & participated in conferences with industry, CDC, HHS, international regulatory bodies, & others on safety, health hazards, & other drug matters. Represented the FDA on committees & at meetings of national & international scientific, professional & regulatory organizations.Consulted with & advised representatives of other government agencies, industry & the academic community. Interviewed by media on drug-related matters.Served on Suitability Petition committee

I was in private practice in Rheumatology for 6 years and continued the practice on weekends after I went to the FDA in 1998 until 2004. During this time I served on a hospital formulary committee.

I was an attending physician in the Rheumatology Division as part of the Georgetown University Rheumatology Program. This position involved inpatient and outpatient care, teaching of medical students, residents and Georgetown rheumatology fellows, and conducting clinical research including drug company investigator work and Institutional Review Board (IRB) work. I presented at grand rounds and at smaller internal conferences.