Merith Basey’s Post

 🚀 Legislative Update The U.S. Senate has unanimously passed the Affordable Prescriptions for Patients Act, introduced by Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT). This bipartisan legislation addresses abusive patent practices in the pharmaceutical industry, aiming to lower drug prices by: - Ending "patent thicketing" to allow affordable biosimilars to enter the market. - Balancing innovation incentives with preventing anti-competitive behaviors. - Receiving broad bipartisan support, indicating a strong consensus for reform. As the bill moves to the House, there is anticipation for further action to make medications more affordable. #HealthcareReform #AffordableDrugs #BipartisanSupport #PharmaReform

What’s Happening: Proposed legislation focuses on curbing pharmaceutical prices through reducing the periods of exclusivity afforded through patent protections. The Context: Pharmaceutical companies strategically leverage patent protection to safeguard their innovative discoveries and maintain market exclusivity. These patents serve as formidable barriers to entry, allowing companies to recoup their substantial investments in research and development. Moreover, patents enable pharmaceutical firms to enjoy extended periods of exclusivity, during which they can command premium prices for their products, fostering economic incentives for further innovation. In conjunction with patent protection, pharmaceutical companies often pursue fast-track regulatory approvals, such as FDA's Priority Review designation. These expedited pathways not only accelerate market entry but also prolong the exclusivity period by reducing time to market. This creates a compelling economic advantage, as companies can capitalize on their exclusivity window to capture significant market share before generic competition emerges. The exclusivity periods granted by patent protection and regulatory approvals are pivotal components of pharmaceutical companies' commercialization strategies. These periods allow firms to maximize revenue generation by pricing their products at premium levels without immediate competitive pressures. Furthermore, they provide valuable time for companies to establish brand recognition, secure market access, and invest in promotional activities, thereby solidifying their market position and ensuring long-term commercial success. The Impact: The proposed legislation aims to alter the pharmaceutical market dynamics by curbing practices like i) product hopping and evergreening (making minor formulation changes and filing a new patent), ii) patent thickets (creating a dense web of patents), iii) citizen petitions (petitioning the FDA filings of generic competitors), iv) authorized generics (making the market for independent generics less attractive), and v) pay-for-delay (settling patent disputes by paying generic competitors to delay their launch). The legislation aims to reduce the duration of market exclusivity, which would increase competition, likely leading to lower drug prices and more rapid entry of generics and biosimilars into the market. https://lnkd.in/eEAbrXiM Weaver #lifescience #pharmaceutical #biotechnology #patent #IPstrategy

Challenges to pharmaceutical patents could stifle innovation by reducing financial incentives, hinder funding for high-risk projects, and delay access to breakthrough therapies. Balancing drug pricing concerns with patient accessibility is crucial for sustaining healthcare innovation. #PharmaInnovation #Healthcare https://lnkd.in/eiDQcC_N

The FDA racket is simple. 3/4ths of the drug division is funded by Big Pharma …. Is an arms length review remotely possible? ▪️ Excerpt The New York Times The #pharmaceutical industry funding alone has become so dominant that last year it accounted for three-quarters — or $1.1 billion — of the agency’s drug division budget. “It’s kind of like a devil’s bargain,” said Dr. Joseph Ross a professor at the Yale University School of Medicine who has studied FDA policies, “that I think is not in the best interest of the agency, because it turns this every-five-year cycle into the F.D.A. essentially asking industry, ‘What can we do to secure this money?’ ” https://lnkd.in/gAVj2_SB General budget is ONLY 45% funded by Bigs... ▪️ Excerpt 2 Today, close to 45% of its budget comes from these user fees that companies pay when they apply for approval of a #medicaldevice or #drug. https://lnkd.in/g77iFWnj.

US SENATE BEGINS TO CLOSE DOOR ON BIOLOGIC DRUG EVERGREENING Ten years too late! Restricting secondary patenting will help stop the patent thickets but the product hopping must also be stopped. “The bill has been tweaked a bit since its initial proposal. The original version also targeted “product hopping,” a term for when a drugmaker pushes patients toward a follow-up product as the original version of the drug heads toward the patent cliff.” What REALLY needs to happen is at the FDA level. Only products which clinically demonstrate “clinically meaningful” improvements over existing therapy should be considered for approval. And then, any clinically meaningful improvement must be objectively qualified via cost benefit types of analysis, e.g. used by ICER or UK's NICE. Of course, along with imposition of price increases at CPI, cost-benefit would dictate launch price reimbursement. Global Pharma’s US Predatory pricing business model would be eliminated, and the industry would finally be forced to consolidate and rationalize to survive, which is long overdue. #pharmaceuticals #patents #drugprices #drugs #ussenate #fda #costbenefit #icer #nice #fda #phrma #bio #cmo #cdmo #cro https://lnkd.in/ewpUGMu3

Novo Nordisk Leads BioPharma Companies in Legal Challenge Against Drug Price Negotiation Provisions in Inflation Reduction Act Novo Nordisk, along with several other biopharma companies, is contesting the drug price negotiation provisions in the Inflation Reduction Act. A lawsuit has been filed by Novo alleging that the act infringes on their First and Fifth Amendment rights. Despite objections, these companies, including Novo, have consented to partake in the negotiation process and adhere […] #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Are you interested in learning more about the ramifications of the upcoming changes to #German #Drug #Pricing and #Reimbursement laws? Our latest blog at Covington's Inside EU Life Sciences provides insights into what implications #Confidentiality Agreements in #Germany could have on #Pharmaceutical #Pricing. Let us share with you what #pharmaceutical companies can expect when #AMNOG gains one more layer of complexity.   #MedicalResearchAct #Medizinforschungsgesetz #MFG #GermanPharmaStrategy #PharmaceuticalPricing #Pricing #MarketAccess #Legislativechanges #LifeSciences #Healthcare #Pharma Dr.iur. Dr.med. Adem Koyuncu | Covington & Burling LLP

STAT+: Oregon suspends a portion of its drug transparency law found to be unconstitutional https://lnkd.in/gZY4qEBd In a victory for the pharmaceutical industry, Oregon officials have suspended a portion of a contentious state law designed to bring more transparency to prescription drug pricing. For now, the Oregon Department of Consumer and Business Services will no longer require drug companies to compile annual reports on price increases, a key feature of a transparency law that was enacted in 2018. At the time, such laws were pursued by several states as a way to force the pharmaceutical industry to justify price hikes that were straining budgets. However, a U.S. District Court judge sided with an industry trade group that had argued a portion of the law was unconstitutional. The Pharmaceutical Research & Manufacturers of America contended in a lawsuit that a requirement to disclose information — including marketing and R&D spending — about a drug that underwent a price hike was forcing… Click here to view original post Click Here to Publish/Feature Your Company or Product News with Biotech Networks

Reinterpreting the #BayhDoleAct to exercise so-called march-in authority as price controls on prescription drugs threatens #biopharma innovation to the detriment of millions of patients. Read more about the need for IP and patent protections in RealClear Health:

I vaguely remember march-in rights from preparing to sit for the patent bar many years ago- an obscure government power that has essentially never been used. This all may change now. What exactly this will mean for drug pricing and pharmaceutical innovation - or the future of rare disease research - remains to be seen but it is certainly the latest twist (wrinkle?) in the national drug pricing debate. Good STAT article explaining the issue. https://lnkd.in/e4NKc3jp