Client
- Name
- REGENXBIO
- Location
- Maryland · United States of America
Registrant
- Firm
- REGENXBIO
- Description
- Gene Therapy Biotechnology Company
- Location
- Rockville, Maryland, United States of America
Lobbying activities
5 issuesHealth Issues
Issues affecting biotechnology firms engaged in developing gene therapies, including: the MVP Act (H.R.2666) authorizing value based payments under the Medicaid program; Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices; Changes to the Orphan Drug Act; and, Potential legislative or administrative changes to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies (e.g., MedPAC recommendations to cap prices for FDA AAP-approved products under certain circumstances.) Efforts to enact a so-called "reasonable pricing clause" in NIH licenses and CRADAs
LobbyistsBRUCE ARTIM
Covered position (BRUCE ARTIM): Senate Judiciary Committee Staff Member 1995-2006; (Chief Counsel and Staff Director 2003-04); Intellectual Property Subcommittee - Chief Counsel and Staff Director 2005-06)
TargetedSENATE · HOUSE OF REPRESENTATIVES · Health & Human Services, Dept of (HHS) · Patent & Trademark Office (PTO) · Food & Drug Administration (FDA) · Centers For Medicare and Medicaid Services (CMS) · Natl Institutes of Health (NIH)
Trade (domestic/foreign)
Covid vaccine and potential waiver of IP rights for covid therapeutics and diagnostics. Strong patent and regulatory data protection for biopharmaceuticals in trade agreements.
LobbyistsBRUCE ARTIM
Covered position (BRUCE ARTIM): Senate Judiciary Committee Staff Member 1995-2006; (Chief Counsel and Staff Director 2003-04); Intellectual Property Subcommittee - Chief Counsel and Staff Director 2005-06)