Brian advises companies on a broad range of legal and regulatory issues throughout all phases of a product’s life cycle, including:
(i) developing appropriate strategies for the introduction of new ingredients and finished products,
(ii) coordinating pre-market safety, efficacy, and claims evaluations,
(iii) preparing FDA-related applications and notifications,
(iv) designing compliant and effective labeling, advertising, and promotional materials, as well as educational materials,
(v) ensuring post-marketing regulatory compliance, including compliance with adverse event reporting requirements and limitations on off-label promotion, and
(vi) responding to threatened enforcement action and litigation.
As part of this work, Brian coordinates efforts between product developers, contract research organizations, site management organizations, institutional review boards, investigators, and the FDA.
Much of Brian’s practice involves crisis management support. Brian assists clients in preparing for and during government investigations, as well as in evaluating and responding to adverse product information. He has coordinated numerous recalls, market withdrawals, and other product corrective actions.
Brian conducts regulatory compliance audits to ensure that both product manufacturers and distributors are in full compliance with applicable laws and regulations. Further, he has drafted proposed federal and state legislation in support of the interests of manufacturers and distributors and represented these interests before legislators and regulators.
Brian works extensively with attorneys in the firm’s Health Care, Intellectual Property , and Corporate Transactional practices. He has negotiated numerous licensing, supply and distribution agreements; conducted numerous due diligence audits of acquisition targets; prepared regulatory compliance opinions in support of public offerings; and supported food and drug-related litigation.