REGENXBIO for REGENXBIO
What was lobbied
5 issue areas, each in the filer's own words, with who lobbied on it and where.
Health Issues HCR
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
| Lobbyist | Covered position, as disclosed |
|---|---|
| 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) |
Trade (domestic/foreign) TRD
Covid vaccine and potential waiver of IP rights for covid therapeutics and diagnostics. Strong patent and regulatory data protection for biopharmaceuticals in trade agreements.
| Lobbyist | Covered position, as disclosed |
|---|---|
| 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) |
Copyright/Patent/Trademark CPT
Proposals to change subject matter patent eligibility under Section 101 and other proposals to amend the patent code as they relate to gene therapies and other biopharmaceutical innovations, including: S.2140, the Patent Eligibility Restoration Act and the Coons/Tillis-Buck/Ross PREVAIL Act related to PTO PTAB reform. Assertions of March In Rights under the Bayh-Dole Act or under Section 1498 against biopharmaceutical products. Efforts to impose "reasonable pricing clauses" on patent licenses from NIH-grantees to commercial partners. The ongoing PTO-FDA collaboration on drug pricing.
| Lobbyist | Covered position, as disclosed |
|---|---|
| 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) |
Immigration IMM
Proposals to change immigration laws and policies that affect the ability of biopharmaceutical firms to recruit and retain non-U.S. citizens.
| Lobbyist | Covered position, as disclosed |
|---|---|
| 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) |
Taxation/Internal Revenue Code TAX
Proposals to allow the direct expensing of R&D expenditures, including S.866, the American Innovation and Jobs Act (S.866) and the Build It in America Act (H.R. 3938).
| Lobbyist | Covered position, as disclosed |
|---|---|
| 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) |
Shown as published by the Senate Office of Public Records and the House Clerk under the Lobbying Disclosure Act. The official filing is the record; open it for the full form.