Sunday, October 22, 2023

And... Here Is What Amgen Cajoled Congress-Critters About -- In Q3 2023...


Yet and still, the biggest story here at the moment. . . is that after a vast drop off in the first half, Pfizer (see below post) is back to spending vast sums to jawbone Congress.

Each of these pharma / life science companies aim for the same general buckets, but each has a unique sweet spot -- where it seeks, more than any other. . . a particular business advantage. For Amgen, that is a leg up, on regulations applicable to biological therapeutic agents. And, as the graphic at right makes plain -- Amgen and Merck are once again spending about the same amount per quarterly period:

. . .Issues related to drug pricing reform: Changes to Public law 117-1769 Inflation Reduction Act; Awareness of implications to patients and research and development of Public law 117-1769 Inflation Reduction Act; S. 113 Prescription Pricing for the People Act of 2023; S.127 Pharmacy Benefit Manager Transparency Act; HR 830 / S 1375 HELP Copays Act; HR 485 Protecting Health Care for All Patients Act; HR 1613 to amend title XIX of the Social Security Act to improve transparency and prevent the use of abusive spread pricing and related practices in the Medicaid program; R 2534 PROTECT 340B Act of 2023; HR 3561 the PATIENT Act; S. 1542 DRUG Act; S. 1967 PBM Act; HR 3503 The NIH Clinical Trials Diversity Act; Proposed rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program. . . .

HR 4818 / S. 2407 Treat and Reduce Obesity Act; S. 2305 Biosimilar Red Tape Elimination Act; S. 2129 Ensuring Access to Lower-Cost Medicines for Seniors Act; Modernizing and Ensuring PBM Accountability Act (Finance Committee); S. 652 SAFE Step Act; S 2474 / HR 5376 Share the Savings with Seniors Act; S 2456 Protecting Seniors from High Drug Costs Act; HR4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program; HR 3281 Protecting Patients Against PBM Abuses Act; HR 4822 Health Care Price Transparency Act of 2023; S 1339 Pharmacy Benefit Manager Reform Act; HR 2679 Pharmacy Benefits Manager Accountability Act; HR 4507 Transparency in Coverage Act of 2023; HR 1352 Increasing Access to Biosimilars Act of 2023; HR 2880 Protecting Patients Against PBM Abuses Act; Issues related to PAHPA reauthorization; Issues related to cardiovascular disease awareness and treatment; Issues related to Federal Trade Commission; FDA issues; Issues related to patient affordability issues, including copay cards, copay accumulators, copay maximizers, National Benefit Payment Parameters; Biosimilars reimbursement issues, no specific bill; Supply Chain Issues, no specific bill; Issues related to 340B; Issues related to pharmacy benefit managers. . . .

HR 4507 Transparency in Coverage Act of 2023; S 2474 / HR 5376 Share the Savings with Seniors Act; S 2456 Protecting Seniors from High Drug Costs Act; HR4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program; HR 1352 Increasing Access to Biosimilars Act of 2023; HR 2880 Protecting Patients Against PBM Abuses Act; Issues related to PAHPA reauthorization; Issues related to cardiovascular disease awareness and treatment; Issues related to ESRD; Issues related to asthma and self-administered drug list; Issues related to reimbursement for biologics/biosimilars. . . .

Issues related to corporate and international tax, including regarding Public Law 115-97, Tax Cuts and Jobs Act; Issues related to Puerto Rico; Issues related to OECD negotiations on the taxation of global income; HR 3938 Build it in America Act. . . .

S. 79/HR 1717 Interagency Patent Coordination and Improvement Act of 2023; S. 113 Prescription Pricing for the People Act of 2023; S.127 Pharmacy Benefit Transparency Act; S. 150 Affordable Prescriptions for Patients Act of 2023; S. 148 Stop STALLING Act; S. 142 Preserve Access to Affordable Generics and Biosimilars; Federal Trade Commission related issues, no specific bill; S.2140 Patent Eligibility Restoration Act of 2023; S.2220/HR 4370 Promoting and Respecting Economically Vital American Innovation Leadership Act; S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents; H.R. 3858 / S.1834: A bill to prohibit the President from negotiating or concluding any withdrawal, suspension, waiver, or modification to the Agreement on Trade-Related Aspects of Intellectual Property Rights without explicit authorization from Congress; H.R. 3535 Advancing Americas Interests Act; H.R. 5475 Prohibiting Adversarial Patents Act of 2023; Issues related to the Patent Act, no specific bill; Issues related to March-In/Bayh Dole, WTO/TRIPS waiver, no specific bill; Issues related to False Claims Act; Issues related to FDA/PTO coordination; Issues related to patent thickets / product hopping; Issues related to obviousness / double patenting. . . .


Now you know. Grinning into a fun week ahead -- for celebrations, old and new! Back with Merck spend details (and, likely. . . Lilly as well as Amazon) in the coming days. Onward.

नमस्ते

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