Mark Shore’s Post

The FDA’s new Additional Condition for Nonprescription Use (ACNU) pathway, announced in December 2024, is set to revolutionize the pharmaceutical industry by allowing certain prescription drugs to be sold over-the-counter (OTC) with additional safeguards. These safeguards, such as self-selection tests or instructional content, ensure the safe and correct use of these medications without requiring a healthcare provider’s oversight. ACNU aims to improve access to essential medications and promote health equity. A prime example of this is the potential for low-dose statins to be available OTC with digital tools to help consumers determine their eligibility. This could significantly improve access to treatment for cardiovascular health, especially for those who face barriers to seeing a doctor. For consumers, ACNU increases accessibility, affordability, and safety. For companies, it provides an opportunity to expand market reach, establish leadership in consumer-friendly health tools, and streamline regulatory processes while leveraging real-world data to support innovation. https://lnkd.in/dX7nKVN4

Why are GLP-1s so much more expensive in the U.S. than in other countries? 🤔 Our CEO, Geoff Cook, shared insights in NewBeauty on the pricing landscape: “Pharmaceutical companies in the U.S. can set prices as high as the market will bear. There’s very little direct negotiation compared to other parts of the world, and the result is that patients pay the price.” At Noom, we’re committed to making GLP-1 medications more affordable through our Noom GLP-1ᴿˣ program. But long-term solutions require systemic change in drug pricing. Read more: bit.ly/3XMyd99

Another insightful piece by Adam Fein in Drug Channels highlights a significant issue regarding patients in the pharmaceutical supply chain. His concluding statement is particularly revealing: patients continue to feel the negative effects as net drug acquisition prices decrease for intermediaries but not for the end users. Here’s the quote: "Unfortunately, the warped incentives of today’s drug channel will continue to slow change. As I have long argued, legislation should shield patients from the excesses of the gross-to-net bubble while enhancing the competitive pressures that are reducing the gap between list and net prices."

In recent developments, Johnson & Johnson faces a class-action lawsuit in Australia, accused of selling ineffective cold and flu medications containing phenylephrine. Despite studies indicating its ineffectiveness as an oral decongestant, products like Codral Cold and Flu and Sudafed PE were marketed for nearly two decades. Meanwhile, the U.S. Congress is scrutinizing Pharmacy Benefit Managers (PBMs), intermediaries in the pharmaceutical supply chain. Proposed legislation aims to mandate that PBMs pass drug manufacturer rebates directly to employer-sponsored health plans, potentially increasing transparency and reducing drug costs. Additionally, Novo Nordisk has secured regulatory approval to acquire three manufacturing sites, addressing shortages of its popular weight-loss drugs, Wegovy and Ozempic. This strategic move could reshape pharmaceutical manufacturing dynamics, especially concerning contract manufacturers. These events highlight the complex interplay between pharmaceutical companies, regulatory bodies, and consumers. They underscore the ongoing challenges in ensuring drug efficacy, transparency in drug pricing, and the stability of drug supply chains. Is it conceivable that the very mechanisms designed to ensure our health are, through intricate layers of bureaucracy and profit-driven motives, inadvertently perpetuating inefficiencies and inequities within the system? This post was generated by my custom-built personal agent, powered by LLMs and designed to operate my computer. If you're curious about how it works, feel free to ask!

💊 New blog post alert! Explore the key pharmaceutical trends from the first half of 2024. Discover how rising drug prices, increased use of generics, specialty medications, and regulatory changes are shaping the future of healthcare for providers, insurers, and patients. 📈🩺 Access the link to read the full article: https://lnkd.in/dvFwd64P #InterceptRx #PharmaTrends #HealthBenefitsInsights #2024Trends

Expert Discusses the Impact of Medicare Drug Pricing Reforms on the Pharmaceutical Industry: Access to certain drugs may be limited through tighter formulary controls and utilization management by Medicare Part D plans dealing with higher costs #finance #pharmacy #lifesciences

In the latest edition of the "Welcome to the Future" series, Marcos Cortes, Managing Director of A&M’s Corporate Transactions Group, examines the implications of the Inflation Reduction Act (IRA) on pharmaceutical research and development. As the industry allocates a substantial share of revenue to R&D, adjustments in drug pricing are likely to affect upcoming R&D budgets and strategies. Check out Marcos's insights on Medicare drug negotiation under the IRA and its potential effects on the pharmaceutical sector and future innovation investments. https://okt.to/KSaqVF #InflationReductionAct #CorporateTransactionsGroup

A big shout out to Bharath Krishnamurthy, MPH, and Megha Parikh, PhD, MS for shedding light on the true drivers behind the escalating drug costs and the pharmaceutical industry's focus on the #340B Drug Pricing Program. Their insightful analysis uncovers how the pricing strategies of major pharmaceutical companies, combined with soaring prices of new drugs and aggressive market dominance tactics, are contributing to the growth of the 340B program. Pharma continues to attribute the program as the cause, while also limiting access to affordable generics and prioritizing profits over patient well-being. It is evident that the 340B program plays a crucial role in supporting hospitals and underserved communities, and it is important to protect it from misleading criticisms. #340Bprogram #protect340B #dei #medicationaccess #pharma #drugprices American Hospital Association Pharmacy Quality Alliance Medical Economics #populationhealth #patientcare #healthcare #healthcareconsulting #safetynet

In a recent RealClearHealth article, "One-Size-Fits-All Drug Pricing Will Deter Post-Approval Research and Hurt Patients” Peter Rheinstein discusses the Medicare Drug Price Negotiation program, part of the Inflation Reduction Act(#IRA), for its potential to stifle post-approval drug research. By grouping drugs with the same active ingredient into a single price category, even if used for different conditions, the program disincentivizes pharmaceutical companies from pursuing new, potentially life-saving applications for existing medications. Rheinstein argues that this approach will reduce innovation and harm patients by limiting treatment options. Rheinstein states: “According to a study from the University of Chicago economists, the IRA's price controls -- and officials' overly broad definition of what counts as a qualifying single-source drug -- will lead to 109 fewer post-approval indications over 20 years. It now seems as if that prediction was too optimistic. Price controls inherently restrict the supply of any good or service, whether it's oil in the 1970s or medicines in the 2020s. But by disincentivizing post-approval research, officials are compounding the IRA's damage -- and needlessly depriving patients of potentially lifesaving new uses for already approved therapies.” Peter Rheinstein, M.D., J.D., is president of Severn Health Solutions, past president of the Academy of Medicine of Washington, DC, chairman of the United States Adopted Names Council, chairman of the American Board of Legal Medicine, a delegate to the American Medical Association House of Delegates, and a former president of the Academy of Physicians in Clinical Research. Read the full article: https://lnkd.in/ex5P7xUA #IRA #DrugPriceControls