Author: Peter

An FDA advisory panel knocked down Pfizer and BioNTech's pitch for COVID-19 booster shots for everyone, but rebounded on the committee's follow-up allowance for third shots in the elderly and high-risk people...he committee voted 16-2 to reject Pfizer’s bid for a full approval for boosters for people 16 and older...“It may eventually be indicated for the general population,” committee member Ofer Levy, M.D, said. “I just don’t think we’re there yet in terms of the data.”...READ MORE

Ahead of a highly anticipated meeting that could influence how soon coronavirus booster shots become widely available in the U.S., staff at the Food and Drug Administration appeared to take a neutral view of whether the agency should authorize a third dose of Pfizer's vaccine..."Some observational studies have suggested declining efficacy of Comirnaty over time against symptomatic infection or against the Delta variant, while others have not," the reviewers said in the document, using the brand name for Pfizer's vaccine. "[B]ut FDA has not independently reviewed or verified the underlying data or their conclusions."...READ MORE

Medicare Advantage insurer SCAN Health Plan will expand its coverage options into Arizona and Nevada for the 2022 plan year, the company announced....The growth marks the first time that SCAN has expanded beyond California and into two new markets at the same time, according to the announcement. The insurer boasts 220,000 members in the Golden State...SCAN Health Plan (Nevada) will offer plans in Clark County, Nevada and SCAN Desert Health Plan (Arizona) will provide coverage in Maricopa, Pima and Pinal counties...READ MORE

Sutter Health has agreed to pay the federal government $90 million to settle allegations that it submitted inaccurate information on some of its Medicare Advantage beneficiaries...The settlement, announced by the Department of Justice...comes less than a week after a major $575 million settlement was finalized on allegations the health system overcharged patients. The federal government has been heavily scrutinizing improper coding practices from MA insurers, which experts say is a likely driver of increased Medicare spending...DOJ alleges that Sutter “knowingly submitted unsupported diagnosis codes for certain patient encounters for beneficiaries under its care,”...“These unsupported diagnosis codes caused inflated payments to be made to the plans and Sutter Health.”...READ MORE

As officials in Washington weigh contentious drug-pricing measures, there's even more evidence that pharma companies are worried about potential reform...In an open letter to Congress, the heads of major biopharma companies...wrote that one proposal in particular—allowing Medicare to negotiate drug prices—would "threaten patients' access to medicines and sacrifice future medical advances."...READ MORE

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

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

...the U.S. Food and Drug Administration announced the reorganization of the agency's information technology, data management and cybersecurity functions into the new Office of Digital Transformation...The office has been realigned to report directly to the FDA commissioner, elevating the office and its functions to agency-level. This reorganization will advance the agency’s information technology transformation with improved data and IT competencies that improve agency operations to support the public health mission...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

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