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1st Quarter - Report · 2026

Filing UUID
aa3a50d4-e002-4373-a5cf-812a7ace6757
Type
Q1 — 1st Quarter - Report
Period
first_quarter
Year
2026
Posted
2026-04-20 18:19:45
Income (reported)
Expenses (reported)
$1,620,000
Expenses method
C
Filing document
Open on lda.senate.gov
Registrant (lobbying firm)

BIOTECHNOLOGY INNOVATION ORGANIZATION

Trade Association

Contact
AIKEN HACKETT
Phone
+1 202-962-9200
Address
zip:20005, city:Washington, state:DC, street:1201 New York Avenue NW Suite 1300
Client

BIOTECHNOLOGY INNOVATION ORGANIZATION

State
DC
Country
US
Government-entity client
false
Effective date
2016-01-01
Issues lobbied + lobbyists (9)

BUD — Budget/Appropriations

FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---Centers for Medicare and Medicaid Services (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CMMI Models: GLOBE and GUARD ---Funding for Section 317 ---Funding for Strategic National Stockpile ---Pandemic Preparedness ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Vaccine Access & Compensation ---Pediatric Priority Review Voucher

Lobbyists:

Government entities lobbied: Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); SENATE

CPT — Copyright/Patent/Trademark

Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act of 2025 ---Patent Tax/fees ---Restrictions on Intellectual Property Rights Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Patent Reform ---H.R.3160/S.1553: PREVAIL Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---PTAB Reform Patenting of Biological Inventions ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization

Lobbyists:

Government entities lobbied: HOUSE OF REPRESENTATIVES; Patent & Trademark Office (PTO); SENATE

HCR — Health Issues

FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---340B Rebate Rule ---Program Implementation & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Purple Book Draft Legislation ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---American Privacy Rights Act ---Clinical Trial Data in China ---Consumer Data Privacy and Security Act (Draft) ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility ---Promising Pathway Act ---PDUFA VII Implementation ---PDUFA VIII Negotiations Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability ---Contract Manufacturing Ecosystem in the United States Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act ---Ensuring Access to Generic Medications Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---S.1302: Increasing Transparency in Generic Drug Applications Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates ---Alternative Payment Arrangements for Gene Therapies National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---Pediatric Priority Review Voucher ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---340B Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications Vaccines and Infectious Diseases ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Coverage Determination ---PASTEUR ACT ---SAFE STEP Act ---Vaccine Access Improvement Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence

Lobbyists:

Government entities lobbied: Centers For Medicare and Medicaid Services (CMS); Commerce, Dept of (DOC); Energy, Dept of; Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Natl Security Council (NSC); Office of Management & Budget (OMB); Office of Science & Technology Policy (OSTP); Office of the Vice President of the United States; Patent & Trademark Office (PTO); SENATE; U.S. Trade Representative (USTR); White House Office

HOM — Homeland Security

FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention Vaccine Programs ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Medical Countermeasure Priority Review Voucher Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---VICP/CICP Biodefense Research, Development and Procurement Issues ---Executive Order on Withdrawing the United States from the World Health Organization ---Implementation of BIOSECURE Act ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---State Strategic Stockpile Act ---WHO Pandemic Preparedness Accord Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Supply Chain Issues ---Medical Countermeasure Priority Review Voucher Reauthorization

Lobbyists:

Government entities lobbied: Commerce, Dept of (DOC); HOUSE OF REPRESENTATIVES; Natl Security Council (NSC); Office of Management & Budget (OMB); Office of Science & Technology Policy (OSTP); Office of the Vice President of the United States; SENATE

MED — Medical/Disease Research/Clinical Labs

FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Advanced Research Projects Agency for Health (ARPA-H) Act ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Medical Countermeasures ---Funding for Section 317 ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV Reauthorization ---Pandemic Flu ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---VICP/CICP Antimicrobial Resistance Biodefense Research, Development and Procurement Issues ---Medical Countermeasure Priority Review Voucher Reauthorization CDC Reform Pandemic Preparedness ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures

Lobbyists:

Government entities lobbied: Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); SENATE

MMM — Medicare/Medicaid

FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---340B Rebate Rule ---Executive Order on Access to Affordable Life-Saving Medications ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Antimicrobial Resistance Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilars Competition (General) ---Biosimilar Copay ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Clinical Trial Data in China Data Privacy ---Data Privacy Working Group Draft Drug Evaluation and Review ---FDA Hiring Staffing Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---International Pricing Policies ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act ---Tariffs Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---International Pricing Policies ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 ---NSCEB Recommendations Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---H.R.6166: Lowering Drug Costs for American Families Act ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures ---Supply Chain Issues Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---340B Rebate Rule ---CMMI Authority ---National Coverage Determination ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence

Lobbyists:

Government entities lobbied: Centers For Medicare and Medicaid Services (CMS); Commerce, Dept of (DOC); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Natl Security Council (NSC); Office of Management & Budget (OMB); Office of Science & Technology Policy (OSTP); Office of the Vice President of the United States; Patent & Trademark Office (PTO); SENATE; U.S. Trade Representative (USTR)

SMB — Small Business

Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act

Lobbyists:

Government entities lobbied: HOUSE OF REPRESENTATIVES; Natl Institutes of Health (NIH); SENATE; Small Business Administration (SBA)

TAX — Taxation/Internal Revenue Code

FY 2026 Appropriations for Specific Issues ---Vaccines and Infectious Diseases ---VICP/CICP Capital Formation Incentives ---American Innovation and Jobs Act Incentives for Domestics Manufacturing Orphan Drug Issues ---H.R.1262/S.932 Mikaela Naylon Give Kids a Chance Act ---Implementation of ORPHAN Cures Act ---Pediatric Priority Review Voucher ---Cameron's Law Pandemic Preparedness Research & Development Tax Credit Reforms ---H.R.1: One Big Beautiful Bill Act ---Expensing of R&D Expenditures ---R&D Payroll Credit Vaccines and Infectious Disease ---Countermeasure Injury Compensation Fund Amendment Act ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Vaccine Injury Compensation Modernization Act ---Vaccine Access Improvement Act

Lobbyists:

Government entities lobbied: Commerce, Dept of (DOC); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; SENATE

TRD — Trade (domestic/foreign)

CFIUS and Foreign Investment Drug Pricing ---CMMI: GLOBE and GUARD Models ---International Pricing Policies ---Most Favored Nation Drug Pricing Proposals ---Reference Pricing in Drug Reimbursement ---Tariffs Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations Foreign Drug Data Protection Laws ---Implementation of BIOSECURE Act Global Supply Chain Resiliency Incentives for Domestic Manufacturing Intellectual Property International Enforcement ---China Synthetic Biotech ---S.3741: Biosecurity Modernization and Innovation Act of 2026 Tariffs Trade Relations ---Section 232 ---Genetic Resources, and Associated Traditional Knowledge ---World Intellectual Property Office (WIPO) - Treaty on Intellectual Property ---US-China IP Provisions United Nations World Trade Organization (WTO) ---TRIPS Waiver

Lobbyists:

Government entities lobbied: Commerce, Dept of (DOC); HOUSE OF REPRESENTATIVES; Natl Security Council (NSC); Office of Science & Technology Policy (OSTP); Office of the Vice President of the United States; SENATE; U.S. Trade Representative (USTR)

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