Why It Matters

Neurim Pharmaceuticals Ltd., an Israeli CNS-focused drug developer, has filed a new lobbying registration with Polsinelli PC, marking its first known U.S. federal lobbying activity in more than two decades. The company's last recorded lobbying engagement dates to 2004, when it worked with Ward and Associates on consumer and health issues. This registration signals a renewed push into Washington at a moment when pharmacy policy is drawing significant congressional attention.

By the Numbers

The filing, signed May 5, 2026, lists no reported dollar amount for the engagement. Polsinelli PC's lobbying team on this account consists of one lobbyist: Michael Gaba. Over the past two years, Gaba has worked on 19 lobbying disclosures totaling $570,000 across five clients, with a heavy concentration in healthcare and pharmaceutical issues.

His prior clients include Avanos Medical Inc., for which he logged $360,000 in filings focused on non-opioid pain management and trade tariffs, and ResQ Pharma Inc., where he worked on FDA regulatory issues across seven filings. No prior congressional staff experience was found for Gaba in available records. Polsinelli PC represents a broad portfolio of roughly 34 clients, with healthcare and medical device work making up the bulk of its congressional lobbying activity.

The Agenda

The registration lists one issue area: Pharmacy (PHA). No specific legislation or bills are identified in the disclosure. Given the broad issue code, there are relevant bills and policy debates in the pharmacy and pharmaceutical space that could intersect with Neurim's interests, though the filing does not specify which. Neurim's prior 2004 lobbying covered consumer issues and health policy more broadly, offering little direct guidance on its current priorities.

Broader Context

Neurim develops pharmaceutical-grade melatonin products, including Circadin, a prolonged-release melatonin tablet approved for primary insomnia in patients 55 and older, and Slenyto, a pediatric formulation approved in Europe for insomnia in children with Autism Spectrum Disorder, ADHD, and other neurogenetic disorders. Both products are approved in dozens of countries, but are not commercially available in the United States.

A central regulatory obstacle is that melatonin is classified as a dietary supplement in the U.S. under the Dietary Supplement Health and Education Act of 1994, not as a prescription drug. The NIH's National Center for Complementary and Integrative Health has noted that melatonin "is regulated less strictly by the Food and Drug Administration than a prescription or over-the-counter drug would be." No federal legislation has changed that classification.

Slenyto was developed under a U.S. FDA Investigational New Drug application, according to a PR Newswire release, signaling prior FDA engagement. Neurim also maintains an Expanded Access Policy for Slenyto in the U.S. under compassionate use conditions. At the BIO International Convention in 2025, the company was actively seeking a U.S. strategic partner with expertise in pediatric neurology to out-license the product. Separately, Neurim recently signed an exclusive licensing agreement with KYE Pharmaceuticals Inc. to bring Slenyto to Canada, according to the company's news page.

Between the Lines

Congressional activity on pharmaceutical policy has been active in the period surrounding this registration. A Senate hearing titled "Hearings to Examine Making Medicines More Affordable, Focusing on How Competition Can Lower Drug Prices" was held on April 16, 2026. A separate Senate hearing on "Foreign Dependence, Focusing on China and America's Drug Supply" took place on March 11, 2026.

Member communications in the past year have reflected broad interest in pharmaceutical manufacturing and pricing. Rep. Darin LaHood (R-IL-16) discussed pharmaceutical innovation and U.S. clinical infrastructure in March 2026. Sen. Rick Scott (R-FL) released a report in October 2025 focused on securing the foreign generic pharmaceutical supply chain. Sen. Tom Cotton (R-AR) introduced the Combatting Counterfeit Pharmaceuticals Act in February 2026. No member communications specifically mentioning Neurim Pharmaceuticals were found in the reviewed period.

Competitive Landscape

Polsinelli PC's existing pharmaceutical client ResQ Pharma Inc. has been active on FDA regulatory issues, with seven filings over the past two years. Central Admixture Pharmacy Services Inc., another Polsinelli client, has lobbied on the implementation of the Drug Quality and Security Act. No other lobbying disclosures from companies working on directly comparable pharmacy issues to Neurim's specific product profile were identified in the available data.

The Bottom Line

Neurim's lobbying registration represents a return to Washington after a long absence. The company faces a distinct regulatory environment in the U.S., where its core products occupy uncertain ground between dietary supplement and prescription drug classifications. The engagement with Polsinelli PC and lobbyist Michael Gaba, whose recent work has centered on FDA regulatory and Medicare coverage issues, positions Neurim within a firm that has established relationships in the healthcare policy space. The disclosure does not specify what policy outcomes the company is seeking.

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