By EAS Senior Consultant Les Weinstein, JD, MPA
Every Center in FDA, except CFSAN, has an Ombudsman; there is also an Ombudsman in the Office of the Commissioner. I am the only person to have served as the Ombudsman in two different Centers: the Center for Tobacco Products (CTP) for three years and the Center for Devices and Radiological Health (CDRH) for ten years, working in the Office of the Center Director in each position.
An FDA Ombudsman investigates external complaints about the agency; negotiates, mediates or otherwise facilitates the resolution of disputes between FDA and regulated companies; and responds to inquiries from stakeholders who have been unable to get answers elsewhere in FDA.
An Ombudsman, accessible to regulated industry, eases their way to being heard; listens to their issues and concerns; informs them of the regulatory process; and strategizes with them on options to challenge or appeal a decision. Often an Ombudsman is the catalyst that results in an equitable solution to a problem.
I think that having been an Ombudsman at FDA is the perfect segue to being a consultant to companies regulated by FDA. Both roles involve advocating for fairness on behalf of industry; fostering meaningful engagement with the agency; and providing information and assistance to companies in resolving specific issues and problems.
Based on my experience as the CTP Ombudsman, I can help EAS tobacco clients navigate their way through a new Center with new procedures and in compliance with a new law. Specific tobacco topics I have been involved in include: substantial equivalence, deeming (e-cigarettes, cigars, hookah), retail inspections and compliance, menthol, export/import, harmful and potentially harmful constituents, labeling, registration, standards, modified risk, adverse events, graphic health warnings, flavor ban, and user fees.
EAS clients can also benefit from my CTP and CDRH experience handling more general issues that are of concern to all industries that are regulated by FDA, not just tobacco and device companies. These included: level playing field, transparency, regulatory compliance, status of premarket and other submissions, miscommunication or lack of communication, meeting requests, difficult or unresponsive FDA employees, and of course dispute resolution. I also attended meetings between companies and FDA to ensure that they were listened to in a forum that was conducive to effective and productive dialogue.
I am available to make presentations at conventions, conferences, workshops, and other industry sponsored meetings on my new role as an EAS Senior Consultant. This is part of my outreach efforts to inform trade and professional associations and their members about what I did as an FDA Ombudsman, how I did it, and how I might now be of assistance to EAS clients and potential clients.