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John Shakow's practice focuses on complex regulatory, commercial, investigation and litigation issues related to pharmaceutical government pricing and price reporting. A partner in our FDA and Life Sciences practice, John represents pharmaceutical and biotechnology manufacturers in every facet of government drug payor program compliance.
John has 20 years of 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, the Federal Supply Schedule, 340B 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 over a dozen 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 has counseled drug manufacturers before the House Energy & Commerce and Senate Finance committees in drug-pricing investigations and inquiries; drafted briefs in the only U.S. Supreme Court case to address drug pricing (Santa Clara County v. Astra); and represented a major pharmaceutical manufacturer in the nationwide Average Wholesale Price litigation. His pharmaceutical litigation experience also includes best-efforts marketing arbitration between manufacturers and litigation before the Drug Enforcement Administration over licensing to import controlled substances.
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