Alice Valder Curran | Washington, D.C. | Hogan Lovells

Alice Valder Curran

Partner Global Regulatory

Valder Curran Alice

Alice Valder Curran
Valder Curran Alice
  • Overview
  • Experience
  • Credentials
  • Insights and events

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.

Representative experience

Successfully advocated to DOJ that it accept a manufacturer's routine restatement of Medicaid pricing data in lieu of pursuing an FCA matter.
Successfully advocated to HRSA that two categories of long-standing policy guidance were nonbinding on manufacturers.
Convinced CMS that certain products were entitled to new and distinct baseline AMPs because of their differences from prior, related products.
Supported a successful manufacturer audit of a 340B-covered entity suspected of diversion and duplicate discounts.
Supported policy advocacy efforts with CMS regarding the treatment of value-based pricing arrangements under the AMP/BP/ASP reporting requirements.
Advised manufacturers regarding limited distribution arrangements under the 340B Drug Pricing Program.
Coordinated review of launch strategies and associated commercial contracts and patient programs for multiple new product launches.
Advised manufacturers regarding 340B ceiling price restatement obligations and refunds to covered entities.

Credentials

Education
  • J.D., Columbia Law School, 1992
  • B.A., Pomona College, cum laude, 1989
Bar admissions and qualifications
  • District of Columbia
Memberships
  • Member, American Health Lawyers Association

Recognition

Life Sciences Star: Healthcare Pricing & Reimbursement

LMG Life Sciences

2018 - 2020
Regulatory Attorney of the Year: Pricing and Reimbursement

LMG Life Sciences

2018 - 2019
Healthcare (District of Columbia), Rank 3

Chambers USA

2022

Events

Hogan Lovells Events

21 November 2024 | 10:00 a.m. - 11:00 a.m. (CST/HKT/SGT) | 11:00 a.m. - 12:00 p.m. (JST) | 1:00 p.m. - 2:00 p.m. (AEDT) | 9:00 p.m. - 10:00 p.m. (EST - Wednesday, 20 November 2024)

Hogan Lovells Events

17 October 2024 | 12:00 p.m. - 1:30 p.m. (EST)

Hogan Lovells Events

12 September 2024 | 10:00 a.m. - 11:00 a.m. CST/HKT/SGT | 11:00 a.m. - 12:00 p.m. JST | 12:00 p.m. - 1:00 p.m. AEST | 10:00 p.m. - 11:00 p.m. EDT (Wednesday, 11 September 2024)
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