As some senators ramp up their push for health care price transparency, consumer advocates are cheering the renewed attention and urging lawmakers to include bipartisan transparency legislation in a year-end health package once Congress reaches a deal to end the government shutdown stalemate.
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Makary: FDA To Eliminate Comp Efficacy Studies As Part Of Major Biosimilars Announcement
FDA Commissioner Marty Makary signaled a major drug pricing announcement from the White House later today will aim to significantly reduce drug prices by boosting biosimilars -- including new FDA guidance eliminating comparative efficacy study requirements, calls for all biosimilars to be interchangeable with their reference products, steps to increase onshoring and pleas for biosimilars makers to significantly lower prices.
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After HHS Secretary Robert F. Kennedy Jr. recently signaled to governors he wants to analyze the efficacy of statins, which are widely prescribed to lower cholesterol and often used to prevent cardiovascular disease, figures in the Make America Healthy Again (MAHA) movement also question the drugs’ use with the medication being a hot topic at the MAHA Institute’s Oct 21 roundtable.
OpenAI -- the parent company of ChatGPT -- convened an expert group of physicians and psychologists to help it significantly reduce the risks the artificial intelligence-powered chatbot poses to users struggling with mental health disorders and children.
A group of Democratic senators is demanding greater transparency and “accountability” from Commerce Secretary Howard Lutnick on the administration’s use of a national security statute to impose duties on an expanding number of sectors, including pharmaceuticals and medical devices, charging that those measures have undermined the law’s purpose.
Texas Attorney General Ken Paxton is testing the legal reach of the president and his health officials’ demands for drug label updates based on what is widely viewed as unsubstantiated evidence, suing Tylenol maker Kenvue for defying the administration’s calls to add autism warnings to its popular painkiller’s label.
Senate Democrats are urging CMS to immediately open the federal health insurance exchange marketplace, healthcare.gov, for window shopping, arguing that many consumers are still in the dark about their 2026 premiums since the agency gave insurers’ permission not to include specific rate and tax credit information in renewal notices this year.
Despite the ongoing government shutdown, the Trump administration is continuing to face a variety of lawsuits over its health care policies, including over defunding Planned Parenthood, laying off federal workers and terminating grants.
Two leading public health experts criticized HHS Secretary Robert F. Kennedy Jr.’s “Make America Healthy Again” strategy report, saying it did not correctly identify the largest drivers of death and chronic disease in America and overlooked proven approaches to improving health.
Hospitals want CMS to delay implementation of its new Medicare prior authorization pay model, WISeR, in order to address a swath of concerns the American Hospital Association has, including how the demonstration’s pay structure incentivizes claims denials, omits patients from the appeals process, and does not hold participating companies to the prior authorization standards announced by the administration earlier this year, among many other concerns.