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John Shakow focuses on complex regulatory, commercial, investigation and litigation issues related to pharmaceutical government pricing and price reporting. A Chambers-ranked partner in our FDA and Life Sciences practice and co-chair of the firm's Life Sciences & Healthcare Industry Group, John represents pharmaceutical and biotechnology manufacturers in every facet of government drug payor program compliance and liability mitigation.
John has over 25 years' experience in helping pharmaceutical and biotechnology clients resolve commercial and organizational challenges while maintaining the integrity of their price-reporting compliance efforts.
He counsels clients on their rights and obligations under Medicaid, Medicare,340B, VA/FSS and related programs, and regularly assists them in interactions with the Centers for Medicare and Medicaid Services, the Health Resources and Services Administration, the Department of Health and Human Services Office of Inspector General, and the Veterans Administration.
John often conducts in-depth pricing assessments to develop and implement government price calculation and reporting policies, procedures, systems and methodologies. John has overseen dozens of substantial bona fide service fee analysis projects for large and small drug manufacturers. He is experienced in managing the coordination and integration of pricing methodologies in major pharmaceutical mergers.
John has significant pharmaceutical litigation and investigation experience. He regularly challenges government agencies' positions on drug pricing and reimbursement matters, and defends clients in federal and state investigations related to price reporting. John represents manufacturers in 340B, IRA, and Medicaid Drug Rebate Program litigation, and has counseled drug manufacturers before the House Energy & Commerce and Senate Finance committees in drug-pricing investigations and inquiries.
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