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 FDAcAAP-approved products under certain circumstances.) Potential amendments to the Food, Drug and Cosmetic Act, the Public Health Service Act, or the Social Security Act that would impact the provision of cell and gene therapies (no specific legislation):.
-
Potential amendments to the Social Security Act to allow value-based pricing under Medicaid (HR 2666)
Development of legislation that would affect the research, regulation or pricing of biopharmaceuticals, including implementation of the Inflation Reduction Act (no specific legislation)
Monitor discussion of proposals to affect the R&D Tax Credit (no specific legislation)
Duration: May 3, 2021
to
January 31, 2024
General Issues: Health Issues , Medicare/Medicaid , Pharmacy , Taxation/Internal Revenue Code
Spending: about $665,000 (But it's complicated. Here's why.)
It can be tricky to figure out how much an organization spent on a particular lobbying engagement. The law only requires lobbyists to report the amount they were paid for federal lobbying each quarter rounded to the nearest $10,000—and if it's less than $3,000 in a given quarter (or less than $13,000 for organizations with in-house lobbyists), they don't have to disclose it at all. Plus, some organizations include spending that doesn’t belong in the report—for instance, money spent lobbying state governments or other legal work.
Agencies lobbied since 2021: U.S. Senate, House of Representatives
Lobbyists
Lobbyists named here were listed on a filing related to this lobbying engagement. They may not be working on it now. Occasionally, a single lobbyist whose name is spelled two different ways on filings may be represented twice here.
Lobbyist
Covered positions?
Patricia Knight Chief of Staff, Senator Orrin G Hatch; Health Policy Director, Senator Orrin Hatch/HELP Committee, Judiciary Committee
Chief of Staff, Senator Orrin G. Hatch; Health Policy Director - Senator Orrin Hatch
Chief of Staff, Senator Orrin G. Hatch; Health Policy Director, Senator Orrin G. Hatch
Chief of Staff, Senator Orrin Hatch; Health Policy Director, Senator Orrin Hatch.
Disclosures Filed
Once a lobbying engagement begins, the lobbyist or firm is required to file updates four times a year. Those updates sometimes change which lobbyists are involved or add new issues being discussed. When lobbyists stop working for a client, the firm is also supposed to file a report disclosing the end of the relationship.
1st Quarter, 2024
Knight Capitol Consultants terminated an engagement in which they represented ReGenxBio on April 23.
Original Filing: 301577027.xml
4th Quarter, 2023
In Q4, Knight Capitol Consultants lobbied for ReGenxBio , earning $50,000. The report was filed on Jan. 22.
Original Filing: 301541095.xml
Lobbying 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 FDAcAAP-approved products under certain circumstances.) Potential amendments to the Food, Drug and Cosmetic Act, the Public Health Service Act, or the Social Security Act that would impact the provision of cell and gene therapies (no specific legislation):.
-
Agencies Lobbied
U.S. Senate
Lobbying Issues
Potential amendments to the Social Security Act to allow value-based pricing under Medicaid (HR 2666)
Agencies Lobbied
U.S. Senate
Lobbying Issues
Development of legislation that would affect the research, regulation or pricing of biopharmaceuticals, including implementation of the Inflation Reduction Act (no specific legislation)
Lobbying Issues
Monitor discussion of proposals to affect the R&D Tax Credit (no specific legislation)
Type of Issue
Taxation/Internal Revenue Code
3rd Quarter, 2023
In Q3, Knight Capitol Consultants lobbied for ReGenxBio , earning $60,000. The report was filed on Oct. 16, 2023.
Original Filing: 301501891.xml
Lobbying 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 FDAcAAP-approved products under certain circumstances.) Potential amendments to the Food, Drug and Cosmetic Act, the Public Health Service Act, or the Social Security Act that would impact the provision of cell and gene therapies (no specific legislation):.
-
Agencies Lobbied
U.S. Senate
Lobbying Issues
Potential amendments to the Social Security Act to allow value-based pricing under Medicaid (HR 2666)
Agencies Lobbied
U.S. Senate
Lobbying Issues
Development of legislation that would affect the research, regulation or pricing of biopharmaceuticals, including implementation of the Inflation Reduction Act (no specific legislation)
Lobbying Issues
Monitor discussion of proposals to affect the R&D Tax Credit (no specific legislation)
Type of Issue
Taxation/Internal Revenue Code
2nd Quarter, 2023
In Q2, Knight Capitol Consultants lobbied for ReGenxBio , earning $60,000. The report was filed on July 19, 2023.
Original Filing: 301484615.xml
Lobbying 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 FDAcAAP-approved products under certain circumstances.) Potential amendments to the Food, Drug and Cosmetic Act, the Public Health Service Act, or the Social Security Act that would impact the provision of cell and gene therapies (no specific legislation):.
-
Agencies Lobbied
U.S. Senate
Lobbying Issues
Potential amendments to the Social Security Act to allow value-based pricing under Medicaid (HR 2666)
Agencies Lobbied
U.S. Senate
Lobbying Issues
Development of legislation that would affect the research, regulation or pricing of biopharmaceuticals (no specific legislation)
Lobbying Issues
Monitor discussion of proposals to affect the R&D Tax Credit (no specific legislation)
Type of Issue
Taxation/Internal Revenue Code
1st Quarter, 2023
In Q1, Knight Capitol Consultants lobbied for ReGenxBio , earning $60,000. The report was filed on April 20, 2023.
Original Filing: 301465506.xml
Lobbying Issues
Potential amendments to the Food, Drug and Cosmetic Act, the Public Health Service Act, or the Social Security Act that would impact the provision of cell and gene therapies (no specific legislation):to
any successor to the Guthrie-Schrader MVP Act (formerly HR 7389) authorizing Medicaid value-based payments;
-Changes to the Orphan Drug Act;
-legislation affecting reimbursement of pharmaceuticals, including potential amendments to the Inflation Reduction Act;
-
Agencies Lobbied
U.S. Senate
Lobbying Issues
Potential amendments to the Social Security Act to allow value-based pricing under Medicaid (no bill number yet)
Agencies Lobbied
U.S. Senate
Lobbying Issues
Development of legislation that would affect the research, regulation or pricing of biopharmaceuticals (no specific legislation)
Lobbying Issues
Monitor discussion of proposals to affect the R&D Tax Credit (no specific legislation)
Type of Issue
Taxation/Internal Revenue Code
4th Quarter, 2022
In Q4, Knight Capitol Consultants lobbied for ReGenxBio , earning $60,000. The report was filed on Jan. 19, 2023.
Original Filing: 301435541.xml
Lobbying Issues
Potential legislation implementing value based purchasing for pharmaceuticals (HR 7389); Possible provisions related to Drug Pricing Legislation that affect biological products' development, approval, accelerated approval, and marketing, including deliberations associated with the Reauthorization of the Prescription Drug User Fee Act ( HR 7667) (S 4348), or the continuing resolution(Further Extendjnf Government Funding Act P.L. 117-70. Possible drug pricing legislation included in any budget reconciliation legislation ( no specific number). Reauthorization of the Newborn Screening Saves Lives Act (HR 482, S 350.) Consolidated Appropriations Act, 2033. ( PL 117-328).
Agencies Lobbied
U.S. Senate
Lobbying Issues
Inclusion of provisions affecting the reimbursement of gene therapies that may be contained in any drug pricing legislation or budget legislation (H.R. 3 or its successor; the Build Back Better Act (HR 5376)/or any successor reconciliation bill. Development of Value Based Purchasing legislation ( HR 7389). Consolidated Appropriations Act, 2023 (PL 117-328).
Agencies Lobbied
U.S. Senate
Lobbying Issues
Possible legislation which may affect Food and Drug Administration review of biologic products (Consolidated Appropriations Act, 2023, PL 117-328).
Lobbying Issues
Potential changes in the corporate tax rate or other provisions of interest to business (Build Back Better Act, H.R. 5376 or any successor budget reconciliation legislation; Consolidated Appropriations Act, 2023, PL 117-328).
Type of Issue
Taxation/Internal Revenue Code
3rd Quarter, 2022
In Q3, Knight Capitol Consultants lobbied for ReGenxBio , earning $60,000. The report was filed on Oct. 17, 2022.
Original Filing: 301406263.xml
Lobbying Issues
Potential legislation implementing value based purchasing for pharmaceuticals (HR 7389); Possible provisions related to Drug Pricing Legislation that affect biological products' development, approval, accelerated approval, and marketing, including deliberations associated with the Reauthorization of the Prescription Drug User Fee Act ( HR 7667) (S 4348), or the continuing resolution(Further Extendjnf Government Funding Act P.L. 117-70. Possible drug pricing legislation included in any budget reconciliation legislation ( no specific number). Reauthorization of the Newborn Screening Saves Lives Act (HR 482, S 350.)
Agencies Lobbied
U.S. Senate
Lobbying Issues
Inclusion of provisions affecting the reimbursement of gene therapies that may be contained in any drug pricing legislation or budget legislation (H.R. 3 or its successor; the Build Back Better Act (HR 5376)/or any successor reconciliation bill. Development of Value Based Purchasing legislation ( HR 7389).
Agencies Lobbied
U.S. Senate
Lobbying Issues
Possible legislation which may affect Food and Drug Administration review of biologic products (no specific bill)
Lobbying Issues
Potential changes in the corporate tax rate or other provisions of interest to business (Build Back Better Act, H.R. 5376 or any successor budget reconciliation legislation).
Type of Issue
Taxation/Internal Revenue Code
2nd Quarter, 2022
In Q2, Knight Capitol Consultants lobbied for ReGenxBio , earning $60,000. The report was filed on July 20, 2022.
Original Filing: 301395095.xml
Lobbying Issues
Potential legislation implementing value based purchasing for pharmaceuticals (HR 7389); Possible provisions related to Drug Pricing Legislation that affect biological products' development, approval, accelerated approval, and marketing, including deliberations associated with the Reauthorization of the Prescription Drug User Fee Act ( HR 7667) (S 4348). Possible drug pricing legislation included in any budget reconciliation legislation ( no specific number).
Agencies Lobbied
U.S. Senate
Lobbying Issues
Inclusion of provisions affecting the reimbursement of gene therapies that may be contained in any drug pricing legislation or budget legislation (H.R. 3 or its successor; the Build Back Better Act (HR 5376)/or any successor reconciliation bill.
Agencies Lobbied
U.S. Senate
Lobbying Issues
Possible legislation which may affect Food and Drug Administration review of biologic products (no specific bill)
Lobbying Issues
Potential changes in the corporate tax rate or other provisions of interest to business (Build Back Better Act, H.R. 5376 or any successor budget reconciliation legislation).
Type of Issue
Taxation/Internal Revenue Code
1st Quarter, 2022
In Q1, Knight Capitol Consultants lobbied for ReGenxBio , earning $60,000. The report was filed on April 22, 2022.
Original Filing: 301373116.xml
Lobbying Issues
Potential legislation implementing value based purchasing for pharmaceuticals (no specific bill); Possible provisions related to Drug Pricing Legislation that affect biological products' development and marketing, including deliberations associated with the Build Back Better Act (H.R. 5376) and the Infrastructure, Investment and Jobs Act (PL 117-58). Possible authority for a new ARPA-H ( HR 5585)
Agencies Lobbied
U.S. Senate
Lobbying Issues
Inclusion of provisions affecting the reimbursement of gene therapies that may be contained in any drug pricing legislation or budget legislation (H.R. 3 or its successor; the Build Back Better Act (HR 5376)/or any successor reconciliation bill.
Agencies Lobbied
U.S. Senate
Lobbying Issues
Possible legislation which may affect Food and Drug Administration review of biologic products (no specific bill)
Lobbying Issues
Potential changes in the corporate tax rate or other provisions of interest to business (Build Back Better Act, H.R. 5376 or any successor legislation).
Type of Issue
Taxation/Internal Revenue Code
4th Quarter, 2021
In Q4, Knight Capitol Consultants lobbied for ReGenxBio , earning $60,000. The report was filed on Jan. 18, 2022.
Original Filing: 301326390.xml
Lobbying Issues
Potential legislation implementing value based purchasing for pharmaceuticals (no specific bill); Possible provisions related to Drug Pricing Legislation that affect biological products' development and marketing, including deliberations associated with the Build Back Better Act (H.R. 5376) and the Infrastructure, Investment and Jobs Act (PL 117-58). Possible authority for a new ARPA-H.
Agencies Lobbied
U.S. Senate
Lobbying Issues
Inclusion of provisions affecting the reimbursement of gene therapies that may be contained in any drug pricing legislation or budget legislation (H.R. 3 or its successor; the Build Back Better Act (HR 5376)/or any successor reconciliation bill.
Agencies Lobbied
U.S. Senate
Lobbying Issues
Possible legislation which may affect Food and Drug Administration review of biologic products (no specific bill)
Lobbying Issues
Potential changes in the corporate tax rate or other provisions of interest to business (Build Back Better Act, H.R. 5376 or any successor legislation).
Type of Issue
Taxation/Internal Revenue Code
3rd Quarter, 2021
In Q3, Knight Capitol Consultants lobbied for ReGenxBio , earning $60,000. The report was filed on Oct. 18, 2021.
Original Filing: 301302714.xml
Lobbying Issues
Potential legislation implementing value based purchasing for pharmaceuticals (no specific bill); Possible provisions of Drug Pricing Legislation (H.R. 3, H.R. 19, S. 2543 and successor legislation) that affect biological products' development and marketing, including deliberations associated with the Build Back Better Act (H.R. 5376) and the Infrastructure, Investment and Jobs Act (H.R. 3684). Possible authority for a new ARPA-H.
Agencies Lobbied
U.S. Senate
Lobbying Issues
Inclusion of provisions affecting the reimbursement of gene therapies that may be contained in any drug pricing legislation or legislation (H.R. 3 or its successor, including the Build Back Better/reconciliation bill) on infrastructure (H.R. 3684)
Agencies Lobbied
U.S. Senate
Lobbying Issues
Possible legislation which may affect Food and Drug Administration review of biologic products (no specific bill)
Lobbying Issues
Potential changes in the corporate tax rate or other provisions of interest to business (Build Back Better Act, H.R. 5376).
Type of Issue
Taxation/Internal Revenue Code
2nd Quarter, 2021
Knight Capitol Consultants amended a lobbying report for representation of ReGenxBio in Q22021 on July 17, 2021.
Original Filing: 301279050.xml
Lobbying Issues
Potential legislation implementing value based purchasing for pharmaceuticals (no specific bill); Possible provisions of Drug Pricing Legislation (H.R. 3, H.R. 19, S. 2543 and successor legislation) that affect biological products' development and marketing. Possible authority for a new ARPA-H.
Agencies Lobbied
U.S. Senate
Lobbying Issues
Inclusion of provisions affecting the reimbursement of gene therapies that may be included in any drug pricing legislation or legislation on infrastructure (no specific bills)
Agencies Lobbied
U.S. Senate
Lobbying Issues
Possible legislation which may affect Food and Drug Administration review of biologic products (no specific bill)
Lobbying Issues
Potential changes in the corporate tax rate or other provisions of interest to business (no specific bill)
Type of Issue
Taxation/Internal Revenue Code
2nd Quarter, 2021
In Q2, Knight Capitol Consultants lobbied for ReGenxBio , earning $60,000. The report was filed on July 15, 2021.
Original Filing: 301276678.xml
Lobbying Issues
Potential legislation implementing value based purchasing for pharmaceuticals (no specific bill); Possible provisions of Drug Pricing Legislation (H.R. 3, H.R. 19, S. 2543 and successor legislation) that affect biological products' development and marketing. Possible authority for a new ARPA-H.
Agencies Lobbied
U.S. Senate
Lobbying Issues
Inclusion of provisions affecting the reimbursement of gene therapies that may be included in any drug pricing legislation or legislation on infrastructure (no specific bills)
Agencies Lobbied
U.S. Senate
Lobbying Issues
Possible legislation which may affect Food and Drug Administration review of biologic products (no specific bill)
Lobbying Issues
Potential changes in the corporate tax rate or other provisions of interest to business (no specific bill)
Type of Issue
Taxation/Internal Revenue Code
2nd Quarter, 2021
Knight Capitol Consultants filed a lobbying registration on June 29, 2021 to represent ReGenxBio, effective May 3, 2021.
Original Filing: 301272999.xml
Issue(s) they said they’d lobby about: Development of innovative therapies using gene therapy; biomedical research; Prescription drug user fee implementing legislation .
Source: Clerk of the U.S. House of Representatives and Secretary of the Senate
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