Why It Matters

Fortress Biotech Inc. is entering federal lobbying at a critical moment for rare disease drug development. The company’s lobbying agenda centers on reauthorizing the Rare Pediatric Disease Priority Review Voucher (PRV) program—which expired December 2024—and supporting the Give Kids a Chance Act.

The PRV program has proven consequential: 56 vouchers issued since 2012 have yielded treatments for roughly 40 rare pediatric diseases, including sickle cell disease and spinal muscular atrophy. Without reauthorization, companies face pressure to submit applications before September 2026.

By hiring Vogel Group LLC—their first lobbying firm ever—Fortress gains immediate Washington access alongside an industry mobilization that includes BioMarin and the Biotechnology Innovation Organization.

By the Numbers

Fortress Biotech Inc. hired Vogel Group LLC in 2024, marking its first federal lobbying effort. Vogel Group has reported over $30 million in total lobbying fees between 2018 and 2025.

The firm assigned three lobbyists: Ariel Gonzalez, who represented BioMarin on orphan drug tax credits; Venicia Gray, who worked for March of Dimes Inc. on pediatric health issues; and Samir N. Kapadia, who represented pharmaceutical manufacturers.

The Agenda

Fortress Biotech is lobbying on the Give Kids a Chance Act (HR 1262 / S. 932) and PRV program reauthorization. The legislation would expand FDA authority over pediatric cancer drug investigations and reauthorize the PRV program for five years.

The bill enjoys broad bipartisan support with over 65 percent of House members as cosponsors, led by Rep. Michael McCaul (R-TX) and joined by Reps. Gus Bilirakis (R-FL), Debbie Dingell (D-MI), and Kim Schrier (D-WA).

Broader Context

The pharmaceutical industry faces competing pressures around rare disease incentives. While the industry spent a record $227 million on lobbying in H1 2025, orphan drugs now command extraordinary prices—averaging $218,872 annually per patient.

Industry scored a victory with the ORPHAN Cures Act in H.R. 1, which expanded orphan drug exemptions from Medicare price negotiation. The Congressional Budget Office estimated this could cost Medicare $8.8 billion in lost savings over a decade.

Between The Lines

Congress is advancing multiple bills targeting Fortress’s business interests. Beyond the Give Kids a Chance Act, the ORPHAN Cures Act (H.R. 946) by Rep. John Joyce (R-PA) protects orphan drug incentives from Medicare price negotiation. The Scientific EXPERT Act, championed by Rep. Doris Matsui (D-CA), seeks to formalize FDA collaboration on rare disease development.

Competitive Landscape

Fortress joins a crowded advocacy space. BioMarin, BIO, Acadia Pharmaceuticals, Denali Therapeutics, and Alexion Pharmaceuticals are all lobbying on identical legislation, suggesting coordinated industry strategy.

The Bottom Line

Fortress Biotech enters federal lobbying with narrow focus on PRV reauthorization and the Give Kids a Chance Act. While the legislation enjoys bipartisan support, growing scrutiny over orphan drug pricing creates both opportunity and political risk for the industry’s advocacy efforts.

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