Michael S Labson

Michael Labson’s practice spans the full range of pharmaceutical and medical device regulation. He provides strategic advice in dealing with the FDA and other agencies. He has litigated a variety of cases in the life sciences area and has general trial and appellate experience. He works actively on legislative matters. Mr. Labson’s recent work has involved issues such as clinical trial conduct; FDA dispute resolution; user fees; orphan drug, pediatric and market exclusivities; product promotion; anti-kickback compliance; Medicaid rebates; drug samples; GMP and quality system requirements; FOIA; imports and exports; drug pedigrees; life cycle planning; pharmacovigilance; and Rx/OTC switches. Mr. Labson also has expertise on DEA and controlled substances issues, and child resistant packaging requirements. Mr. Labson is actively involved in pro bono work, focusing on civil rights and capital representations. He is one of the firm's two Hiring Partners in Washington, and previously was Co-Chair of the firm’s Diversity Committee. REPRESENTATIVE MATTERS Advised leading biotechnology company on strategic approaches to follow-on biologics proposals. Represented PhRMA on legislation related to drug safety, PDUFA reauthorization, pediatric exclusivity and codification of the Pediatric Rule, and drug importation. Conducted review of sales and marketing compliance policies for leading multinational pharmaceutical company in accordance with Corporate Integrity Agreement. Represented Procter and Gamble in consumer class actions alleging the improper marketing of pediatric cough suppressant products, resulting in a dismissal of the actions based on federal preemption. More Representative Matters PREVIOUS EXPERIENCE PriceWaterhouse Strategic Consulting Group, Staff Consultant (1989-1991) HONORS AND RANKINGS Fellow of the American Bar Association The Best Lawyers in America (2010-2013) Chambers USA - America's Leading Business Lawyers (2008-2012) (“offers comprehensive services to clients on regulatory and legislative strategy and is a rising star in the practice”) Washington DC Super Lawyer, FDA (2012-2013) LMG Life Sciences, “Life Science Star” (2012) PLC Life Sciences, Which Lawyer? Highly Recommended for Regulatory (formerly FDA) - "He is one of the best known FDA practitioners from the younger generation of regulatory lawyers. Can advise on the whole spectrum of regulatory issues for both pharmaceutical and biotech clients" (2003-2012). PRO BONO Mississippi v. Cory J. Maye. Represent defendant in capital murder case in Mississippi. State v. Rogers. Represented defendant in capital murder case in Florida. Kevin Smith. Represent DC inmate in federal custody seeking parole. Outside counsel to the International Biomedical Research Alliance, a nonprofit organization devoted to promoting the advance of biomedical research, including through support of the NIH/Oxford/Cambridge Biomedical Research Scholars Program. Coordinated initiative with Washington Lawyers’ Committee for Civil Rights to review police misconduct cases in Prince George’s County, and brought litigation in two individual cases. Represented Special Master in Vaughn G. litigation regarding special education services in the Baltimore City school system. Twelve John Does v. District of Columbia. Longstanding counsel for plaintiff inmate class regarding conditions at the former Lorton Central Facility. MEMBERSHIPS AND AFFILIATIONS Food and Drug Law Institute, Speaker Drug Information Association