Category: Uncategorized

Just For Grins — Here’s What The Med Tech / Device / Solutions Companies Chatted With Congress About, Thus Far In 2023…

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Since Scott has shown his ignorance about the company, before — here is the run down for Abbott Labs, a ’34 Act reporting company that sits on the next tier down — for life science companies (by market cap), through three fourths of 2023. [We will hopefully get to Baxter International, later this week.]

The spend up at Abbott Park is pretty predictable, given the company’s glucose monitoring and IV solutions footprints.

And it still must derive revenue from the old Ross Labs business — infant and geriatric canned nutrition products — given that it still lobbies on the topic. As a device maker, it also looks at some diagnostics proposals. And as ever — with all the old-line, highly profitable life science companies — it is working to drop its federal taxation footprint. Here’s the rest:

…Public Law 117-2 The American Rescue Plan Act of 2021; Public Law 116-123 Coronavirus Preparedness & Response Supplemental Appropriations Act of 2020; Public Law 116-136 CARES (Coronavirus Act, Relief, and Economic Security) Act; S. 2477/H.R. 1770 Equitable Community Access to Pharmacist Services Act; S. 2922 Advancing Research for Chronic Pain Act of 2023; H.R. 2369 Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021; H.R. 3723 Medical Device Electronic Labeling Act….

Proposals regarding regulatory policies affected by public health emergencies; Proposals regarding diagnostic and serologic coronavirus testing; Proposals related to sterilization of medical devices; Proposals related to the President’s Emergency Plan for AIDS Relief (PEPFAR); Proposals regarding payments across healthcare sites of service; Proposals related to future pandemic preparedness; Proposals related to digital health technologies and innovations; Proposals related to Department of Defense coverage of continuous glucose monitors; Proposals related to the advancement, testing, and detection of Traumatic Brain Injury; Proposals related to medical device cybersecurity; Proposals related to medical device shortages; Proposals related to PT/INR (Prothrombin Time/International Normalized Ratio) testing; Proposals related to warm base manufacturing for public health emergencies; Proposals to advance policies related to effective pain management; Proposals related to heart failure technology….

S. 1000/H.R. 1835 Saving Access to Laboratory Services Act; Proposals regarding PAMA regulations and changes to modernize and update the Clinical Laboratory Fee Schedule; Proposals related to Medicare coverage of continuous glucose monitors; Proposals related to diagnostic testing coverage; Proposals related to medical device reimbursement and coverage….

Proposals related to U.S. global health programs and pandemic preparedness; Proposals to advance global virus surveillance; Proposals related to preserving critical medical supply chains….

Proposals regarding the reauthorization of the Child Nutrition Programs and WIC Program; Proposals related to the reauthorization of the Agriculture Improvement Act of 2018; Proposals related to access to infant formula [Editor’s Note: The old Ross Labs business]….

Proposals related to VA coverage of continuous glucose monitors. . . .

Public Law 115-97 The Tax Cuts and Jobs Act; Public Law 117-169 Inflation Reduction Act of 2022; Proposals to reform domestic and international tax structures….

Proposals related to data privacy/data collection, usage and retention; H.R. 3108 Medical Therapy Nutrition Act of 2021….

Now you know. Gray but warm here — as we hit mid-week…. grinning. Onward.

नमस्ते

Pride Blount County (And The ACLU!) File An Intervening Brief In Support Of Friends Of George’s In Sixth Cir., Tonight…

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As we’ve been reporting since early Spring 2023, Friends of George’s club has won out — in every court it has appeared.

That is so, because the Tennessee state legislature, and Gov. Bill Lee… cannot parse US Constitutional principles of over a half century’s standing. And here, tonight, a fellow traveller, the Pride organization in Blount County Tennessee has joined the appeal, since the Blount County DA tried to stop a Pride parade this past Summer, using the same hare-brained “law”. Here’s a bit — and the full 45 page brief:

…[W]hen courts invalidate a speech-restricting law on facial overbreadth grounds, the Supreme Court has suggested that “all” enforcement may be lawfully suspended. See Virginia v. Hicks, 539 U.S. 113, 119 (2003) (“Overbreadth adjudication, by suspending all enforcement of an overinclusive law, reduces these social costs caused by the withholding of protected speech.”); cf. Sec’y of State of Md. v. Joseph H. Munson Co., 467 U.S. 947, 958 (1984) (“Facial challenges to overly broad statutes are allowed not primarily for the benefit of the litigant, but for the benefit of society — to prevent the statute from chilling the First Amendment rights of other parties not before the court.”). Further, “[c]ourts have regularly held that a plaintiff may seek an injunction applicable to all similarly-situated individuals harmed by the same unconstitutional practice, without the necessity of seeking class action treatment.” Caspar v. Snyder, 77 F. Supp. 3d 616, 642 (E.D. Mich. 2015) (collecting cases).

Thus, “district courts are not categorically prohibited” — as a matter of judicial authority — “from granting injunctive relief benefitting an entire class in an individual suit” as District Attorney Mulroy asserts, even if “such broad relief is rarely justified….” Sharpe v. Cureton, 319 F.3d 259, 273 (6th Cir. 2003)….

Now you know. The Memphis DA will lose all the way through to the Supremes, here. Out, grinning into the warm, wet night.

नमस्ते

Paul Mirengoff Cannot — Or More Likely, Will Not — Accept That Fault Falls On All: Gaza / Israel Here…

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I agree with Paul that Israel has every right to defend itself.

But I also know that as recently as three years ago, Israeli soldiers were slaughtering penned up women and children in Gaza — firing randomly into crowds behind chain link fencing. The report had over 18 casualties — most women and children. None armed.

So my central point here is that there is fault all around.

And Mr. Biden is seeking peace… from a place of strength — of character.

We all well-know this is a 3,000 year old dispute — and as ever, all war is hell.

So it ought to be considered statesmanship — to seek an end to the bloodshed, regardless of who got the most recent licks in.

But Paul, and the Powerline boys, are so morally broken — and so many generations removed from any relative that died in any war, anywhere… that they see it all as simply 2024 talking points — sound bites for a coming campaign trail speech-writer.

Damn the lot of you. Out.

And Now… Amazon’s Healthcare / Life Sciences / Employee Related Lobby Spend: Trendlines…

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Here is just a small part of the portfolio of topics on which Mr. Bezos’ empire heckled Congress and US agencies about, in the last 90 days.

His increasingly tight grip on American commerce is beyond serious argument, now. And yet… whether he will be a benevolent oligarch, or a malign one… is still very much an open question. But it is not looking particularly promising, especially on the labor rights front. [He has long been lobbying to weaken labor organizing rights statutes. Ugh. All while his drivers often must pee into bottles while racing his delivery vans from stop to stop — as they get nothing like a realistic daily task load — and rarely get time for a meal during the 8 hour rotating shifts. This… is the “normal” for nearly one million workers he employs — as drivers.]

…Issues related to broadband access and affordability, satellite communications, drones, space safety, spectrum, device accessibility, Section 230 reform, content moderation, and online video, including the ORBITS Act of 2023 (S. 447), the Satellite and Telecommunications Streamlining Act (H.R. 1338) and implementation of the Infrastructure Investment and Jobs Act (P.L. 117-58)….

Issues related to taxes, including renewable energy tax credits, digital goods and services, international and corporate taxation, the American Innovation and Jobs Act (S. 866), the American Innovation and R&D Competitiveness Act (H.R. 2673), Tax Cuts for Working Families Act (H.R. 3936), the Small Business Jobs Act (H.R. 3937), the Build it in America Act (H.R. 3938), and implementation of the Tax Cut and Jobs Act (Public Law 115-97)….

Issues related to cybersecurity, including critical infrastructure protection, payments security, cloud security, authentication, government procurement, cybersecurity incident reporting, and artificial intelligence, including the National Defense Authorization Act for Fiscal Year 2024 (H.R. 2670)….

Issues related to immigration, high-skilled immigration, and non-immigrant visas, including issues related to employment-based visas, green card backlog, the STEM visa exemption provision, the DREAM Act (S. 365), the EAGLE Act (draft bill – no numbers), the Afghan Adjustment Act (H.R. 4627 / S. 2327), and Deferred Action for Childhood Arrivals (DACA)….

Issues related to surface transportation, including autonomous vehicles, alternative fuel vehicles, community infrastructure investments, electric vehicle charging infrastructure, e-bikes, hazardous materials, port congestion, U.S. internal supply chain and goods movement, and maritime transportation; issues related to infrastructure, including implementation of the Infrastructure and Jobs Investment Act (Public Law 117-58)….

Issues related to USDA SNAP online purchasing, including reauthorization of the Agricultural Improvement Act of 2018 (Public Law 115-334), Electronic Benefit Transfer, the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), and food safety. . . .

Issues related to e-commerce opportunities for small businesses and government procurement….

Issues related to IT modernization, cybersecurity, FedRAMP, open data, and government procurement, including the Transportation, Housing and Urban Development, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, and Veterans Affairs Appropriations Act, 2023 (H.R. 8294), the National Defense Authorization Act for Fiscal Year 2024 (H.R. 2670), implementation of the Foundations for Evidence-Based Policymaking Act of 2018 (Public Law 115-435), the FY 2024 Consolidated Appropriations Act (draft bill – no numbers), the Strengthening Agency Management and Oversight of Software Assets Act (H.R. 1695 / S. 931), implementation of the Federal Information Security Management Act (Public Law 107-347), and the Multi-Cloud Innovation and Advancement Act of 2023 (H.R. 4891)….

Issues related to health information technology, healthcare and telehealth, including the Telehealth Expansion Act (H.R. 1843 / S. 1001), the Telehealth Benefit Expansion for Workers Act (H.R. 824), the CONNECT for Health Act (S. 2016 / H.R. 4189), and the Primary Care Enhancement Act (H.R. 3029); and issues related to pharmacy, including the Prescription Information Modernization Act (H.R. 1503)….

Issues related to the Equality Act (H.R. 5 / S. 393), the Justice in Policing Act (draft bill – no number), and cannabis reform, including the States Reform Act (H.R. 5977) and the Cannabis Administration & Opportunity Act (S. 4591)….

Issues related to Amazons Climate Pledge, including alternative fuel vehicles, electric vehicle charging infrastructure, renewable electricity data, federal fleet electrification, maritime and shipping decarbonization, sustainable aviation fuel (SAF), and low-carbon R&D. Issues related to energy and environmental provisions in the Infrastructure and Jobs Investment Act (P.L. 117-58)….

Now you know. I think this closes out our Q3 lobbying sunshine effort. Onward, grinning….

नमस्ते

The Amended Complaint — Adds New Counts — Against Gov. Abbott, In Texas, For His Unlawful, Inhumane Floating Razor Wire On The Rio Grande At Eagle Pass…

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To be sure, the overall matter is now on appeal, with no additional action allowed by Texas at the moment.

But just as surely, the federal agencies have amended their complaint, overnight — to include both an older treaty provision, and to seek a direct order from the court, based on that treaty, forcing Texas (at its state taxpayers’ expense) to remove the razor wire obstruction on the Rio Grande, thus:

…The Supremacy Clause of the Constitution directs that: “This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” U.S. Const. art. VI, cl. 2…. The 1848 Treaty, known as the Treaty of Guadalupe Hidalgo, ended the Mexican / American War, with Mexico ceding certain of its territory to the United States. . . .

Article VII of the 1848 Treaty provides that navigation on the Rio Grande River “shall be free and common to the vessels and citizens of both countries; and neither shall, without the consent of the other, construct any work that may impede or interrupt, in whole or in part, the exercise of this right; not even for the purpose of favoring new methods of navigation.” 1848 Treaty, art. VII…. Accordingly, under the 1848 Treaty, the United States “shall” not construct anything in the Rio Grande that “may” impede or interrupt navigation on the Rio Grande River in any way without Mexico’s consent. This free-navigation requirement is binding and self-executing….

At the time the 1848 Treaty was ratified, the term “navigation” was commonly understood to mean “[t]he act of navigating; the act of passing on water in ships or other vessels.” 1828 Webster’s Dictionary; see also A Dictionary of the English Language (1868) (similar); Oxford English Dictionary (1527-1860) (“a voyage; an expedition or journey by sea or water”); Samuel Johnson’s Dictionary (1773) (“the act or practice of passing by water”)….

And now you know — Abbott is literally… dead in the water, here. Onward, into the 70 degree Fall sunshine, by mountain bike… smiling.

नमस्ते

And… Jenna Ellis Cops A Plea, No. 3 — In Georgia Election Lies Cases…

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Reposting — as Jenna Ellis, the supposed devoutly Christian lawyer, has entered a plea agreement — admitting she’s guilty of crimes — and agreeing to testify against Tangerine and Rudi. This is lawyer number three, in a parade of lawyers admitting that they were criming in Georgia, on behalf of — and at the orders of — Donald John Trump. Ellis looks to have resolved her Colorado bar discipline problems, and will be able to get her license back after probation. [John could not have been more wrong about the import of Sidney Powell’s dam breaking plea last week. And in an update, here on Tuesday afternoon, Hinderaker doubles down — on his idiotic misapprehension of criminal law — claiming this Ellis plea deal is like Soviet show trials of the 1980s. Or something. Except that… there was no trial. She agrees she’s guilty of crimes — and is trying to save her law license in Colorado. And that… she now says Rudi ordered her to do bad things. I realize John has, in his prior practice, done bad things — for clients. But I doubt they were crimes. These were. What an utterly malign idiot he is.] End updated portion.

This is pure genius!

“…Take a load off Fani…

And, and and…

You put the load right on Cheese….”

Courtesy a commenter named Hollywood, at emptywheel.net, this morning.

That’s all I’ve got.

If you don’t know. . . now you know. Courtesy our erstwhile Anon. commenters. . . this refers to Sidney Powell — and a great deep cut from The Band. Grin.

UPDATED: 10.20.2023 @ 1 PM EDT — Now Kenny Cheesebro has cut a deal in Georgia, too. Tangerine is… cooked.

नमस्ते

Merck’s Lobby Spend: Back To Historical / Normalized Levels, In Q3 2023…

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We will wait until later this week to discuss… Amazon. But it will only be that company’s health spend we detail, when we do.

So — here is the likely explanation for Merck’s aberrant Q2 2023 spend: it was trying to win a public opinion war, about price negotiations, with the federal government. That’s a battle it has all but conceded, now. So here’s what the more normal Q3 2023 looked like:

…H.R. 3, (117th Cong.) Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19, (117th Cong.) Lower Costs, More Cures Act of 2021; H.R. 830, Help Ensure Lower Patient (HELP) Copays Act; H.R. 1418/S. 1844, Animal Drug User Fee Amendments of 2023; H.R. 1503/S. 2916, Prescription Information Modernization Act of 2023; H.R. 1550, (117th Cong.) PREVENT HPV Cancers Act of 2021; H.R. 2679, Pharmacy Benefits Manager Accountability Act; H.R. 2691, Transparent Prices Required to Inform Consumer and Employers (Transparent PRICE) Act; H.R. 2816, Pharmacy Benefit Manager Sunshine and Accountability Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; H.R. 2940/S. 1355, Pioneering Antimicrobial Subscriptions To End Upsurging Resistance Act (PASTEUR) Act of 2023; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; H.R. 3285, Fairness for Patient Medications Act; H.R. 4368/S. 2131, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024; H.R. 4895, Lowering Drug Costs for American Families Act; H.R. 5376/S. 2474, Share the Savings with Seniors Act; S. 150, Affordable Prescriptions for Patients Act of 2023; S. 2543 (116th Congress) Prescription Drug Pricing Reduction Act of 2019; S. 1895 (116th Congress) Lower Health Care Costs Act; S. 2333, Pandemic and All-Hazards Preparedness and Response Act; S. 4348, (117th Cong) Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022….

Issues relating to: 340B program integrity; 340B of the Public Health Services Act; 340B issues; 340B drug pricing program; Drug pricing; Anti-microbial Resistance; Vaccines; Cost and value of medicines; Respiratory Syncytial Virus (RSV) immunization; Vaccines catch up; Vaccines issues; Package inserts, labeling issues, and E-Labeling authorization legislation; Pharmaceutical Supply Channel issues; Drug shortage issues; Inflation Reduction Act (P.L. 117-169), issues relating to drug pricing provisions; FY-2023 Budget and Appropriations Legislation; Intellectual property protection and trade issues; WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; WTO IP Waiver for COVID therapeutics; Animal Health; Animal Health Technology Issues; Animal Health Policy Issues: ADUFA & Funding for Electronic Animal Traceability; Animal Drug User Fee Reauthorization; One Health Issues; General pharmaceutical issues; Farm Bill 2023; Vaccine Injury Compensation Program (VICP); Step therapy requirements in commercial health plans; Diversity in clinical trials; Accelerated approval reform; Pharmacy Benefit Manager (PBM) policy issues; Pharmacy Benefit Manager reforms….

H.R. 1613, Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, Medicaid VBPs for Patients (MVP) Act; H.R. 5376, (117th Cong.) Build Back Better Act; S. 476 (116th Congress) Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019….

Issues relating to: Medicare; Medicare Part B and D drug pricing issues; Prior authorization process under Medicare Advantage plans; 340B program integrity; 340B of the Public Health Services Act; 340B drug pricing program; Drug Pricing; FY-2023 Budget and Appropriations Legislation; Medicaid drug rebate program….

Issues related to: Tax reform and tax policy, generally; Tax Cuts and Jobs Act of 2017 (P.L. 115-97); Inflation Reduction Act (P.L. 117-169), provisions relating to taxes….

Smiling — off for a bike ride, along the lake — with golds and flaming reds falling on all sides, in the afternoon sunshine rays. Just. Perfect.

नमस्ते

We Will Toss Lilly On The Pile, As Well — With Insulin Products In Focus…

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So. . . here is the Lilly version, for Q3 2023. And it is… right in line with everyone, except… Pfizer, as adjusted for size of entity. [That is, Pfizer’s spend is… outsized.]

This is the detail — on Lilly’s spend, through three-quarters of 2023 — and plainly, the focus here is protecting insulin pricing, indeed:

…Issues related to intellectual property protection and market access within current trade negotiations. Canada IP; USMCA implementation; Mexico patent linkage; Special 301; Trade talks: US-Japan, US-China, US-EU, US-UK, US-India, and US-Brazil….

[Senate] Patient protection; Drug supply chain and shortages; Drug pricing, coverage, value and access; Transparency; Intellectual property; Health insurance accessibility; Implementation of the “Inflation Reduction Act” (HR.5376); Prescription drug approval; Affordable Insulin Now Act (S.954/HR.1488), The INSULIN Act….

[House] Intellectual property; 340B Program; Medicare & Medicaid prescription drug reimbursement, coverage and value; Implementation of the “Inflation Reduction Act” (HR.5376); CMS National Coverage Determination on Alzheimer’s disease; The INSULIN Act….

Multi-lateral threats to IP and the biopharmaceutical industry; Drug importation; Prescription drug value and access….

Pharmaceutical intellectual property issues….

Implementation of the Tax Cuts and Jobs Act; Domestic manufacturing tax incentives; Expensing of research and development costs; Global minimum tax….

Hospital discounts; 340B program….

Now you are in the know — Lilly obviously focuses on preserving government payor/reimbursement levels, for its insulin products. That, and justifying the vast price increases seen over the last decade in the diabetes therapies regimens. Smile. Merck and Amazon’s health spend — yet to come, this week. Onward.

नमस्ते

Just As Rahway Adds ADC Prospects, With Japan’s Daiichi — It Prunes Two, With China’s Kelun…

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It all makes good sense, to be certain. Merck will, at about 2035, need successor candidates to the juggernaut of pembrolizumab. And so it has time, and cash, on its side. Focusing on the most probable winners makes very solid bioscience- and thus business- sense.[My prior December 2022 backgrounder on the relationship, here.]

While I think the pressers have tended to overstate the actual probable size of the Daiichi-Sankyo ADC deal expansion, it is certainly true that that approach is cheaper, all in, than buying Seagen outright (at ~$44 billion — the tab Pfizer will now pay, just to get in the game here).

Even so, as ever, being disciplined requires a hard look at each interim point along the way to a first clinical trial. And two of Kelun’s ADCs seem to be well-behind those of Daiichi’s. Here’s that story, from Fierce BioScience now:

…Merck is pruning its pipeline of antibody-drug conjugates. Days after the Big Pharma paid $4 billion for three Daiichi Sankyo assets, Kelun-Biotech has revealed the Big Pharma has decided (PDF) to pass over two of its preclinical ADCs.

China’s Kelun has played a starring role in Merck’s drive into ADCs over the past 18 months. The companies penned three pacts in short order, giving Merck rights to a trio of clinical candidates against targets such as TROP2 and CLDN18.2, as well as up to six preclinical prospects. Now, having quickly built a pipeline of nine partnered programs, Merck has told Kelun it is backing out of two of the preclinical projects.

Merck is terminating its license to one preclinical ADC and turning down an option to pick up a second preclinical program. The Big Pharma told Kelun it remains committed to the broader ADC collaboration and plans to “rapidly advance the clinical development program” for the TROP2-directed MK-2870….

Now you know — and onward (back to lobbyists, this afternoon!)… smiling. Ever, smiling.

नमस्ते

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

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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