Six key pharma friendly lawmakers will likely have left Capitol Hill by the beginning of 2025, presenting a challenge for the drug industry. https://trib.al/cZyLAMv
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Pharma policy and legal friends, if you are interested in the intersection of law and policy, William Sarraille is worth following.
NEW: Johnson & Johnson and Bristol Myers Squibb Co.'s bids to block a government drug price-setting program were dismissed by a federal judge Monday. Another loss to the pharmaceutical industry in the #IRA lawsuits. Bristol Myers appealed the ruling Monday. https://lnkd.in/ddiTYDH2
J&J, Bristol Myers Squibb Lose Biden Drug Price Plan Lawsuits
news.bloomberglaw.com
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Nationally Recognized Expert in Health Care and Life Sciences, Educator, Regulatory Consultant, Patient Access Advocate, Independent Director, and Retired Sidley Austin Partner
#IRA Challenge Turned Aside: Part 1 #Janssen and #BMS took it on the chin yesterday, with the federal court rejecting all their challenges to IRA price “negotiation”. The opinion does have some weaknesses, however. A Bright Side?: Where other courts have not even reached the merits, this case at least was on the merits. Not a Taking: The court, citing a case called Horne, which involved the gov’s taking of raisin crops, correctly stated that the crucial issue here is whether the IRA amounts to “physically taking” drugs (as opposed to merely regulating them). The court held that, notwithstanding the brutal excise tax a #drug maker must pay if it sells to a #Medicare patient without the “fair price”, no physical taking occurs. The court said that the raisin farmers in Horne faced a different situation as they were threatened with a physical taking of their crops. But, perhaps significantly, the gov did not physically take the farmers’ raisins in Horne. What the gov actually did was subject the farmers to a punishing tax, b/c they would not hand over their raisins. That actually sounds more like plaintiffs here. If they don’t transfer the drugs at MFP, a crushing tax follows. Further, the court misreads Horne to require that the “entire” value of property must be appropriated in a taking. Similarly, the court says that no taking occurs under the IRA b/c it only applies to Medicare sales. But Horne said the exact opposite. A physical taking is a physical taking—large or small. If it occurs, it does not matter if it applies to the whole market, a market segment, or even a single pill. The court also argues that the drug makers can avoid the IRA hit by “divest[ing] their interest[s]”. But that same point was made about the raisin growers in Horne, where the gov argued that the farmers could have sold their farm. The Supremes dismissed that argument. Voluntariness: The court’s back-up position is that, even if a taking occurred, it’s ok b/c the drug makers participate in Medicare “voluntarily”. That section of the decision starts off oddly, however, relying on cases saying that providers, not subject to the IRA, participate voluntarily in Medicare. But the court then points, more convincingly, to the #ChamberofCommerce and #Astrazeneca cases, which held manufacturer participation under the IRA to be voluntary. But there are 2 weaknesses here. 1) The court relies again on the idea that drug makers could “exit[] from…Medicare” or sell to purchasers “other than” the gov. Those just sound like versions of what the Supremes rejected in Horne, though. 2) In the #ACA case, the Supremes held that a program originally entered into voluntarily could become involuntary—the Supremes said that the costs of Medicaid expansion were high enough that not allowing states to opt out w/out penalty was coercive. But this court doesn’t address this case. See the great article below from Nyah Phengsitthy. Part 2 to follow. #drugpricing
NEW: Johnson & Johnson and Bristol Myers Squibb Co.'s bids to block a government drug price-setting program were dismissed by a federal judge Monday. Another loss to the pharmaceutical industry in the #IRA lawsuits. Bristol Myers appealed the ruling Monday. https://lnkd.in/ddiTYDH2
J&J, Bristol Myers Squibb Lose Biden Drug Price Plan Lawsuits
news.bloomberglaw.com
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📢🇺🇸Back in February, we discussed state-level solutions for drug costs, like Prescription Drug Affordability Boards. Today, we're diving into the first lawsuit of this kind: Amgen v. Colorado Prescription Drug Affordability Board. 🏛️💊 Colorado reviewed 604 drugs and found Enbrel unaffordable, starting a process to set a price cap. Amgen argues that this violates the Constitution, citing the Supremacy Clause, Commerce Clause, and Due Process clause. The outcome could impact similar efforts in other states. Stay tuned! 📈⚖️ Victor Agbafe #HealthcarePolicy #DrugPricing #AmgenVsColorado #AffordableMedicine #HealthLaw
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It is currently incomprehensible to most individuals, including our senators, how drug prices get set in the US. Bristol-Myers Squibb, Johnson & Johnson, and Merck CEOs were on Capitol Hill to answer questions about the steep drug prices in the United States. Their testimony highlighted the complexity, with the senators themselves visibly floundering in their attempts to decipher the mechanics behind pricing. This sets forth an urgent question: If those elected to represent the public interest cannot fathom this system, how can the average citizen be expected to navigate it? We must address another pivotal question: What can be done to simplify drug pricing and make it more comprehensible for all? How can pharmaceutical companies ensure transparency and accountability in their pricing practices? Some have attempted to do that by sharing research, development and even advertising costs with the public. Most companies have patient assistant programs that provide for discounted or free drugs. What else can be done? Interestingly, what kept emerging, and is really the thorniest question of all: What is to be done about PBM's, who kept coming up as the "real" villain in all of this. I look forward to their testimony which will no doubt be happening soon. I expect it will look very similar to Charlie on Always Sunny in Philadelphia. For more information on the Senate hearing, please refer to the following article: https://lnkd.in/eNWFXFMs. #bmsemployee
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Science-Based Nutrition. Rated #1 on supplementcharts.com We have built a revolutionary Cell-G three-stage nanoparticle processor with ultra high-dense layered Phospholipids that delivers 11 times more than non-liposome
Big Pharma ☠️ WATCH THIS BREIF VIDEO HOW IT GOES WITH BIG PHARMA CEO's WHEN THEY'RE QUESTIONED ABOUT THEIR LIES BY THE COURT! https://lnkd.in/ghhvJMdC
Viral Moment: Katie Porter Grills Pharmaceutical Exec Over Drug Price Hikes Amidst Stock Buybacks
https://www.youtube.com/
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It is currently incomprehensible to most individuals, including our senators, how drug prices get set in the US. Bristol-Myers Squibb, Johnson & Johnson, and Merck CEOs were on Capitol Hill to answer questions about the steep drug prices in the United States. Their testimony highlighted the complexity, with the senators themselves visibly floundering in their attempts to decipher the mechanics behind pricing. This sets forth an urgent question: If those elected to represent the public interest cannot fathom this system, how can the average citizen be expected to navigate it? We must address another pivotal question: What can be done to simplify drug pricing and make it more comprehensible for all? How can pharmaceutical companies ensure transparency and accountability in their pricing practices? Some have attempted to do that by sharing research, development and even advertising costs with the public. Most companies have patient assistant programs that provide for discounted or free drugs. What else can be done? Interestingly, what kept emerging, and is really the thorniest question of all: What is to be done about PBM's, who kept coming up as the "real" villain in all of this. I look forward to their testimony which will no doubt be happening soon. I expect it will look very similar to Charlie on Always Sunny in Philadelphia. For more information on the Senate hearing, please refer to the following article: https://lnkd.in/eNWFXFMs. #bmsemployee
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In our new video, Tahir Amin unpacks how Bristol Myers Squibb amassed dozens of additional patents on its top-selling drug Eliquis, and then weaponized those patents to sue competitors and prevent them from entering the U.S. market. In Europe, Bristol Myers Squibb’s monopoly over Eliquis ended in 2022. However, by exploiting loopholes in the U.S. patent system the company has blocked American patients from accessing generics until at least 2026-2031. Knowing that American patients in need of Eliquis have no generic options, Bristol Myers Squibb charges over $7,100 for the drug in the U.S. In the United Kingdom, where patients do have access to generics, the company charges $100. Watch the video to learn the ins and outs of Bristol Myers Squibb’s patenting tactics, how legislators are starting to scrutinize the company’s abuse, and what we can do to prevent companies like Bristol Myers Squibb from price gouging American patients and payers.
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This week, despite lawsuits from drugmakers and their lobbyists, Medicare is going to start its negotiations on 10 high-cost drugs. As part of those negotiations, the 10 drugmakers must provide all of their patenting data. Drugmakers have always made the number of patents they file on a drug a closely guarded secret. Historically, that lack of critical data has prevented policymakers from making fully informed decisions and kept patients, advocates, and experts searching around in the dark for the real numbers. Let's see if this pressure from the federal government (and the threat of fines) is enough to get drugmakers to be honest and deliver the transparency and access to legitimate patent information patients deserve. https://lnkd.in/g5nhe8aU
Drug Makers Agree to Negotiate With Medicare on Prices of 10 Medications
https://www.nytimes.com
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The Inflation Reduction Act introduced several changes to Medicare Part D starting in 2025, emphasizing federal negotiation of prescription drug prices and requiring drug manufacturers to pay rebates, while adjustments to Part D out-of-pocket maximums and creditable coverage determinations are expected to impact employer-sponsored plans significantly. Learn more: https://ow.ly/TllZ50RstFP
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The Inflation Reduction Act introduced several changes to Medicare Part D starting in 2025, emphasizing federal negotiation of prescription drug prices and requiring drug manufacturers to pay rebates, while adjustments to Part D out-of-pocket maximums and creditable coverage determinations are expected to impact employer-sponsored plans significantly. Learn more: https://ow.ly/Gouz50RsjM9
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