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Bausch Health...has been riddled in controversy for years over its defense of diabetes med Glumetza...the company will pay millions to put those charges to rest...Bausch has agreed to dish out $300 million to settle a 2019 lawsuit that claimed the Canadian drugmaker paid off its generic rivals nearly a decade ago, allowing the company to jack up prices for the type 2 diabetes heavyweight by 800% shortly thereafter...READ MORE

Several high-profile U.S. Food and Drug Administration officials are resigning from their positions within the federal agency in protest of the Biden administration’s overreach when it comes to COVID-19-related scientific decisions such as booster shots...Despite the lack of clear evidence in support of booster shots, the Biden administration plans to move forward with supplemental jabs for adults beginning as early as the White House’s Sept. 20 deadline, pending the FDA’s approval. This pressure from the Democrat president and his administration to offer “premature and unnecessary” consent to something that scientific data does not conclusively back up, reports indicate, is causing strife within the regulatory agency...READ MORE

Horse dewormer falsely believed to treat COVID-19 in short supply in Reno...Deworming season is fast approaching for horse owners in Northern Nevada. Every September through November, horses are administered medications containing ivermectin to stave off life-threatening parasitic intestinal worms...But this year, feed stores are having a difficult time keeping large-animal ivermectin medications on the shelves due to a spike in interest in the drug's use as a home remedy for COVID-19...READ MORE

The Biden administration has delayed enforcement of key parts of a major insurer price transparency rule by six months until July 1, 2022, to give plans more time to comply...The Centers for Medicare & Medicaid Services announced the change in a new guidance released Friday focusing on the final price transparency rule released last October under the Trump administration. The guidance focuses on a requirement that certain health plans disclose online their in-network provider rates for covered items and services, out-of-network allowed amounts and billed charges for certain items and services...READ MORE

The Department of Health and Human Services wants to test models that would pay drugs based on their clinical value as part of a new plan to tackle high prices...The plan...lays out several administrative tools the agency plans to take to address high prices. It also calls on Congress to adopt several reforms such as giving Medicare price negotiation authority and cap Part D catastrophic spending...“By promoting negotiation, competition, and innovation in the health care industry, we will ensure cost fairness and protect access to care,” HHS Secretary Xavier Becerra said in a statement...READ MORE

... the reorganization plan conditionally approved by a federal judge Wednesday protects what some call "the most evil family in America" from any civil liability...Under the plan, the Sackler family would forfeit ownership of Purdue Pharma, turn over more than 30 million documents and pay $4.5 billion. In return, the Sackler family would be shielded from an onslaught of lawsuits. Purdue has said the settlement overall will be worth about $10 billion, which includes the value of addiction treatment and overdose antidote drugs it is developing...READ MORE

With 25,000 unresolved lawsuits alleging that its talcum products cause cancer, Johnson & Johnson is considering a legal maneuver sometimes referred to as the Texas two-step... a U.S. judge declined to block the move, giving the pharmaceutical giant the option to create a new business to absorb liabilities associated with the litigation and then seek bankruptcy protection...U.S. bankruptcy judge...denied a plaintiffs' request to issue a restraining order against J&J to prevent the company from employing the tactic, first used by firms decades ago to mitigate the costs associated with asbestos claims...READ MORE

In the weeks since the Biden administration rolled out its plan to start giving COVID-19 boosters in September, medical experts have questioned the science behind the campaign and the morality of giving third doses when many in the world haven't gotten a first dose. Now, top federal health officials are pushing back...In a meeting with White House pandemic coordinator Jeffrey Zients, Centers for Disease Control and Prevention head Rochelle Walensky, M.D., and acting FDA chief Janet Woodcock, M.D., suggested that the administration scale back its booster campaign for now...READ MORE

No matter how you slice it, the pharmaceutical industry is the central engine of the global health establishment. The industry's larger corporations provide funding for the FDA, the CDC, the WHO; they do this both directly and through NGOs like the EPDA...The ties between the FDA and Big Pharma run deep, and their relationship has become so symbiotic that neither could exist without the other unless massive reforms were to take place. Big Pharma relies on the FDA to approve and rush its products to market, and the FDA relies on Big Pharma to receive its funding...READ MORE

Biopharmaceutical companies will pay more than $3 million to file an application seeking FDA approval of a new drug application or biologics license application during fiscal year 2022. This record charge to evaluate new drugs and biologics reflects agency analysis of additional personnel and resources needed to process its growing workload. The annual program fee paid by each manufacturer with marketed prescription drugs holds fairly even at about $370,000. And while the actual increase in the application fee is not that much, passing the $3 million mark has drawn attention and further concern about FDA’s overdependence on revenue from regulated industry...READ MORE