Fabiana Lacerca-Allen, JD, LLM

#CMS Largely Concedes It’s Violating the #IRA In a document that reeks of trying to bolster its litigation position in the lawsuits with #pharmaceutical manufacturers challenging the #InflationReductionAct, one takeaway is that CMS inadvertently shoots itself in the foot on the “qualifying single source drug” issue. It’s an “own goal” error—though the courts’ willingness, at least so far, to avoid getting to the substance of this issue by relying on procedural issues, makes it uncertain whether manufacturers can pounce on this misstep. The key to CMS’ contrived argument that the statute can be used to trigger price controls for multiple drugs approved under DIFFERENT #newdrugapplications is that the statute uses the term “qualifying #singlesourcedrug”. Its position, reflected in the guidance, is that that term means the complete OPPOSITE of what everyone would. Understand the term “single source”to mean—which, of course, is intimately tied to the specific #NDA (or #BLA). But, right there, in the first paragraph of the fact sheet, the Centers for Medicare & Medicaid Services refer to the #drugs subject to its price “negotiation” as applying to “single source” drugs—the pretense of “qualifying single source drug” is lost. And then in its chart going through the “results” of its “negotiations”, excerpted below, it all but admits that it targeted multiple, distinct Novo Nordisk drugs. In the “drug” column, it conspicuously lists “#Fiasp; Fiasp FlexTouch, Fiasp PenFill; #NovoLog; NovoLog FlexPen; NovoLog PenFill”. Previously, CMS had been careful to mush the drugs together by referring to “NovoLog/Fiasp”. But, here, wanting to beat its chest on its “success”, CMS loses its rhetorical disciple. It’s telling. #lifescienses #drugprucing #drugdiscounts #Medicare #managedcare #MedicareAdvantage #PartD #diabetes

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#BusinessLawToday | The FDA's final rule regulates many laboratory-developed in vitro diagnostic tests as medical devices, ending a decades-long enforcement discretion policy. Read: https://lnkd.in/eR9NYpq3 #BusinessLaw #BusinessRegulation #RegulatedIndustries

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Would be interesting to know if this is similar across industries or if there are specific patterns

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#Generic Drug Company Resolves Price Fixing Claims The woes for generic manufacturers continue. The USAO for the Eastern District of Pennsylvania has announced a resolution with Glenmark Pharmaceuticals involving #FalseClaimsAct, #antitrust, and #antikickback, all related to an price fixing conspiracy. The Drug at Issue: The resolution involved #pravastatin, which is used to treat high #cholesterol and #triglycerides. #FCA: #Glenmark agreed to a—not very impressive—$25 million payment to resolve False Claims Act allegations related to a conspiracy “to fix the price of a generic drug”. The USAO was quick to note that this “collusion” based FCA settlement payment reflected an “ability to pay” reduction. #AKS: The government also alleged that Glenmark “paid and received“ compensation “prohibited by the Anti-Kickback Statute” involving “arrangements on price, supply and allocation of customers” with “other [unnamed] #pharmaceutical manufacturers”. It’s pretty unusual for a defendant in an AKS case to be alleged to have been both on the paying and receiving end of #kickbacks. Lots of Government Programs: The case resolution included #Medicare, #Medicaid, and #Tricare. Deferred #Prosecution: In addition to this FCA settlement, Glenmark had previously entered into a deferred prosecution agreement with the U.S. Department of Justice’s Antitrust Division, which resolved parallel criminal charges. As part of that resolution, Glenmark paid a criminal penalty of $30 million—also based on “its ability to pay”. Although this civil resolution did not involve Glenmark admitting to its wrongdoing, the criminal resolution did. There, Glenmark admitted to “conspiring with two other generic drug companies to fix prices on pravastatin”. A String of Investigations: The #DOJ press release proudly emphasized that this is the “sixth resolution arising from … the … investigation of price fixing by generic drug manufacturers”. It won’t be the last. #lifescienses #healthcare #fraud #healthcarefraud #compliance #healthcarecompliance #generics #genericdrugs

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Teva v. Lilly: Are Antibody Methods of Use Different? As patentee, Teva won a jury verdict of $177m against Eli Lilly for infringing Teva's patent on using CGRP-binding humanized antibodies to treat migraines (#Ajovy vs #Emgality). But, the district court rejected the verdict - finding the genus of antibodies in the method of use claims was not sufficiently supported by the disclosure. The appeal, now pending at the Federal Circuit, could have major implications for the validity of genus claims in biotech method of use patents. Teva's patents claim methods of treating headache disorders using a broad genus of humanized anti-CGRP antagonist antibodies, but only disclose a single antibody within that genus. Teva argues its claims are different than those in Amgen v. Sanofi because they cover a novel method of using an arguably well-known class of antibodies. Reply briefs are still pending and oral argument will likely be scheduled in the coming months. Read more here: https://lnkd.in/gU7QQPpc Kevin Martin, Elaine Blais, Edwina Clarke and Gabriel Ferrante of Goodwin represent the patentee Teva Pharmaceuticals Eli Lilly and Company is represented by J. Michael (Mike) Jakes, Charles Lipsey, William B. Raich, Danielle Duszczyszyn and Charles Collins-Chase of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

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The #FDA has released its revised draft guidance, "Addressing Misinformation About Medical Devices and Prescription Drugs," which updates the 2014 guidance. This new document outlines how firms can effectively address third-party misinformation about their products #online. The FDA’s stance on tailored responsive communications marks a significant step in combating misinformation in the medical field. Explore the key takeaways and what they mean for your organization. #LifeSciences #MedicalDevices

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I’m confused by business antipathy for regulation. Good rules provide predictability and can help avoid liability. Regulations may sometimes go too far, but that doesn’t make the solution no more rulemaking. Business interests may see the end of the Chevron Doctrine as a rainbow leading to higher profits. That may be true, but maybe not so much for businesses as for lawyers: plaintiff lawyers seeking damages awards for worksite injuries, pollution, and other torts, and public interest lawyers suing businesses under subjective interpretation of laws previosusly clarified by administrative experts. And since this Court has clearly gutted the concept of stare decisis in American law, no reason that any loss should discourage any future lawsuit. The absence of an expert administrative function will generate chaos, legal sclerosis, and workers who are less productive from unsafe conditions and injuries. This seems like a careful what you wish for decision.

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In Clinical Lab Products, partner Joyce Gresko shares insight on #FDA’s final rule for lab-developed tests, and what it means for the clinical diagnostics industry. #healthlaw https://bit.ly/3UDT7FS

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As healthcare costs continue to soar, the issue of rising drug prices is a pressing concern for patients, providers, and policymakers alike. The authors delve into the complex world of patent law, pharmacy benefit managers, and regulatory initiatives at the federal and state levels. They also explore some of the innovative approaches being taken to increase transparency and accountability in drug pricing. With so much at stake, policymakers face significant challenges as they seek to balance the needs of patients and the interests of the pharmaceutical industry. Stay informed and engaged on this critical issue! If you're looking for a comprehensive overview of the legal and legislative landscape impacting drug costs, this article is a must-read. Read more here: https://lnkd.in/dPJpgXVk #DrugCosts #HealthcarePolicy #PharmaceuticalIndustry #PatientAccess #HealthcareInnovation

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Monica Chmiewlewski and Alex Maulden authored this recent Applied Clinical Trials article, “An Overview of FDA Diversity-Related Documents for Clinical Trials,” highlighting the key takeaways of several FDA diversity-related guidance documents. #FDA #LifeScience #ClinicalTrials

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FDA's recent final guidance outlines the Agency's thinking on what needs to be included in Predetermined Change Control Plans (PCCPs) for devices containing AI-based software functions. See our analysis here!

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It’s Time to Abandon Percentage-Based Compensation Arrangements For 33 years as a health care attorney, I drafted, offered opinions supporting the lawfulness of, and defended percentage-based compensation relationships in #enforcement proceedings. It’s time to abandon percentage based #compensation in the #pharmaceutical space. The government, though not typically taking the step of trying to mandate them out of existence, has long been suspicious of percentage based payments. For our friends at #DOJ, #OIG, #HHS, and #CMS, the word “percentage” pretty reflexively equates to “#kickback”. They see %-based fees as inherently tied to the “volume and value” of #referrals. orders, and other business between contracting parties, with #AKS and #StarkLaw implications. In the final days of my legal practice before I retired, I helped clients assess and think about the implications of developing efforts in #Congress to follow the #VeteransAdministration’s anti-percentage bent in assessing fees for #NFAMP purposes and, potentially, pushing that out to other #pricereporting systems, including #ASP and the #MDRP. Most of my clients quaked at the thought. That would be so “disruptive” of existing #bonafideservicefee payments to so many contractors, they fretted. #Datafees, #GPO fees, #adminfees, and so many other payments would be affected, they complained. At the time, I worried right along with them. But now I see it differently-and not because I believe, as #lawenforcement does, that percentage fees are ultimately inconsistent with #fairmarketvalue. I just can’t see a way to solve the high list/high #rebate problem—that scourge that drives patient #costsharing and #copays ever higher—without putting #percentagefees down for the count. #PBMs—and their affiliated #plans and specialty #pharmacies—suck the life’s blood from #patients, #employers, #Medicare, #Medicaid, and virtually every one else by exploiting percentage fees. It feeds the high lust beast. What #manufacturers have fought to defend—for years—they should now advocate to sunset. The time has come. #lifesciences #managedcare #MedicareAdvantage #biotech #FMV

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While pharma is not the most active industry in the Unified Patent Court (UPC) so far, its case value is significantly higher than any other industry…   The pharmaceutical sector represented only 6,4% of all UPC cases until now, it is therefore obvious that pharmaceutical companies have been hesitant to use the UPC. However, even if the activity before the UPC in respect of the pharmaceutical field is very low, it is by far at the first position before the UPC when it comes to case value. Looking at the sum of the case values of different action types per industry, pharma takes the lead — accounting for 25% of total case value at the UPC. Consequently, the pharmaceutical sector leads the way on average case value close to 8 times the value of cases in other industries (although, those figures should be tempered by the fact that they included four proceedings filed with a case value of €100million). Read more about the past year's cases before the UPC in Clarivate's latest report: https://lnkd.in/g9PjjNHc

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At the Kulkarni Law Firm, P.C., we've examined the Pharmaceutical Research and Manufacturers of America (PhRMA)'s recent feedback on the FDA's draft guidance concerning the use of Data Monitoring Committees (DMCs) in clinical trials. This draft represents an update to guidelines set in 2006 and recognizes the broader use of DMCs in various clinical settings. PhRMA has expressed support for the essential oversight role of DMCs while suggesting clearer guidelines to protect sensitive data within DMC charters. They advocate for maintaining flexibility in how DMCs access data, opposing automatic multiplicity adjustments that could restrict trial flexibility. Moreover, PhRMA highlights the necessity for guidance that accommodates the unique operational needs of early-phase trials, which vary significantly from those of Phase 3 trials. The Kulkarni Law Firm, P.C. appreciates PhRMA’s proactive approach in addressing these intricate regulatory issues, ensuring that DMC guidelines support both innovation and thorough safety oversight in contemporary clinical trials. #HealthcareLaw #FDARegulation #ClinicalTrials #PhRMA #RegulatoryInsight #MedicalInnovation #klf #kulkarnilawfirm

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📅 Why Filing Patents Early Matters 📅 One of the most critical aspects of IP strategy is timing. ALWAYS file a patent application before YOU disclose the invention – that is the one key rule. Otherwise your invention is no longer new = no patents = sad face. But – you probably don’t know what everyone else in the world is doing or planning on doing. What if someone beats you to it and files something first? Or discloses it at a conference or in a poster? = no patents for you = sad face. Therefore, it’s crucial to file early and protect your innovations from being scooped by competitors. BUT - biotecchie patent applications tend to need some data to show the thing works (or at least that there is a good rationale that the thing works based on what you’ve shown so far). So there is often a compromise between filing early, and filing when you have some data. If push comes to shove, and you HAVE to talk about your invention but have no data, we can still file an application before you disclose, and do what we can to make the invention sound plausible (but not obvious!), and then file a top-up application as soon as you have the data. Preferably, just don’t talk about it! Simples 😼 #syntheticbiology #biotechnology #engineeringbiology #innovation #startups #spinouts #phd #postdoc

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Must see discussion on the value of building strategic thought on patient needs into clinical development early enough so you can make the data case in promotion. Often this happens too late. This little video says a lot! Thanks Lucy Rose and Mark Gaydos

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