Alice Valder Curran

Partner, Global Regulatory at Hogan Lovells

Speaker

Alice Valder Curran advises pharmaceutical manufacturers regarding drug pricing matters, with a particular emphasis on the Medicaid Drug Rebate Program, the Medicare average sales price (ASP) reporting requirement, the Health Resources and Services Administration (HRSA) 340B Drug Pricing Program, and the recently enacted Inflation Reduction Act (IRA). Alice works directly with C-Suite executives on the government pricing (GP) implications of common commercial strategies, and the strategic role that these programs can play for certain drugs. Alice helps manufacturers of all sizes and stages to review product portfolios and identify the impacts the IRA may have on the company’s own products and how it may impact the market more broadly. She also works with commercial and finance personnel on the nuts and bolts of implementing GP obligations and the IRA’s provisions. She teams with her white collar colleagues on related enforcement matters, often taking the lead when interacting with enforcement authorities on the specifics of Medicaid, Medicare, and 340B programs.

Alice counsels pharmaceutical companies on the treatment of various commercial strategies in the government pricing calculations – from wholesaler, GPO, and managed care proposals, to product launch strategies and patient programs. Alice brings valuable insight on the strengths and weaknesses of commercialization trends across the industry. Alice develops GP policy documents, "reasonable assumptions" in support of calculation methodologies, and Centers for Medicare and Medicaid Services (CMS) and HRSA 340B recalculation disclosure submissions.

Policy advocacy rounds out Alice's practice. Her knowledge of these programs and how they impact a manufacturer's day-to-day operations, as well as its strategic interests, make Alice a sought-after resource for evaluating legislative and policy proposals.