LARRY K. HOUCK is a director at Hyman, Phelps & McNamara PC where he provides counsel on regulatory and enforcement actions by the DEA. His career encompasses over 30 years of conducting investigations and negotiating on behalf of both the government and industry. Mr. Houck focuses on controlled substances, prescription drugs, and regulated chemicals, helping clients navigate federal and state licensing, registration, and compliance issues.
Mr. Houck counsels clients throughout the registrant supply chain on administrative, civil, and criminal proceedings. In situations where clients face enforcement action, Mr. Houck has extensive understanding of the DEA’s approach and priorities. He advises pharmaceutical and chemical companies on DEA inspections and audits. By working with clients to review business practices, he helps create the infrastructure to ensure compliant reporting, record keeping, and security.
Before joining Hyman, Phelps & McNamara in 2001, Mr. Houck served as a DEA diversion investigator and policy staff coordinator. As a diversion investigator in the Washington, D.C. and Portland, Oregon, field offices, Mr. Houck conducted a full range of regulatory and criminal investigations and inspections of controlled substance and chemical registrants. While serving as a staff coordinator for the DEA’s Office of Diversion Control’s Liaison and Policy, he advised government officials and pharmaceutical and health care professionals on the Controlled Substance Act and its regulations. Mr. Houck drafted and helped implement the DEA’s controlled substance policies and regulations on diversion control issues that included pain management.
LEE ROSEBUSH is a partner at BakerHostetler where he provides his clients with legal counsel that is grounded in first-hand experience. Whether his clients are confronted with legal issues related to the naming of a drug, clinical trials, marketing, promotions, or advertising, Lee possesses a strong understanding of the pharmaceutical industry which, combined with his attention to detail and experience working with biologics, medical device, and healthcare companies, gives clients a single source for regulatory and litigation counsel. With post-graduate degrees in finance and business, Lee is frequently sought out to help expedite corporate deals involving healthcare entities. He also advises private equity and public and private companies in due diligence matters and buy-sell transactions.
Lee’s ability to smoothly shift between the legal, governmental, and pharmaceutical environments further helps him to efficiently secure operating licenses or assist drug manufacturers avoid compliance actions from governmental agencies. Active with the Drug Quality and Security Act (DQSA), as well as the Federal Food and Drug Administration’s (FDA) regulation of pharmacy compounding, Lee speaks and writes on both issues, and is passionate about orchestrating and advocating for pharmacists and pharmacies. Additionally, Lee is Leader of BakerHostetler’s Pharmacy and Reimbursement team and Co-Leader of the FDA, Products Promotion, and Defense team.