FDA’s regulatory decisions are not always based exclusively on facts or science. Often, they are driven in whole or in part by larger policy considerations. For example, FDA often considers what type of precedent its decision will create, how its decision will affect other similar cases before the Agency, how its decision will affect FDA’s workload in the future, and how stakeholders or legislators might react. Consequently, it is essential for clients to understand – and use to their advantage – the policy goals of FDA.
Scott Lassman has been deeply involved in FDA policy since 2002, when he began work at a large trade association representing the pharmaceutical industry. He has served as an industry negotiator with FDA on the Prescription Drug User Fee Act (PDUFA) and has helped guide major legislation through Congress. He has testified before Congress, FDA, and state regulatory agencies and has helped prepare others for such testimony.
Scott routinely helps trade associations and life sciences companies analyze or draft proposed legislation and prepare comments to FDA on proposed regulations, draft guidance documents, citizen petitions, and public hearings and meetings. He also works with companies to implement multi-faceted regulatory strategies that include a policy component, such as outreach to Congress or generating support from interested stakeholders (e.g., patient and physician groups). Scott’s policy work has covered a wide variety of topics, including biosimilars, exclusivity, drug safety (including Risk Evaluation and Mitigation Strategies (REMS)), advertising and promotion, and user fees.
You are invited to contact Lassman Law+Policy for more information on the firm's work in the FDA policy arena.