Securing additional data exclusivity for a major pharmaceutical company

Challenge

Legislation was introduced that provided five years of additional exclusivity for new antibiotics intended to treat serious or life-threatening infections. The client, a leader in the field of antifungals, sought to amend the bill so that these products would likewise qualify for additional exclusivity.

Action

Executed a bipartisan lobbying effort focused on educating the bill’s sponsors and other lawmakers on the House Energy & Commerce and Senate Health, Education, Labor & Pensions (HELP) Committees on the need to include other antimicrobials, such as antifungals. The campaign focused on both the increased costs to society and the healthcare system posed by the paucity of effective antifungals, as well as the critical importance of data exclusivity in encouraging investment and continued innovation in this largely overlooked segment of the market.

Results

Lawmakers expanded the definition of a “qualified infectious disease product” to include antifungals and the measure was signed into law.