Publisher Health

Federal regulators will no longer require patients to provide blood tests before receiving the drug from pharmacies.The Food and Drug Administration has taken a crucial step toward expanding access to the antipsychotic medication clozapine, the only drug approved for treatment-resistant schizophrenia, among the most devastating of mental illnesses.The agency announced on Monday that it was eliminating a requirement that patients submit blood tests before their prescriptions can be filled.Clozapine, which was approved in 1989, is regarded by many physicians as the most effective available treatment for schizophrenia, and research shows that the drug significantly reduces suicidal behavior. Clozapine is also associated with a rare side effect called neutropenia, a drop in white blood cell counts that, in its most severe form, can be life-threatening.In 2015, federal regulators imposed a regimen known as risk evaluation and mitigation strategies, or REMS, that required patients to submit to weekly, biweekly and monthly blood tests that had to be uploaded onto a database and verified by pharmacists.Physicians have long complained that, as a result, clozapine is grossly underutilized.Dr. Frederick C. Nucifora, director of the Adult Schizophrenia Clinic at the Johns Hopkins School of Medicine, said he believed that around 30 percent of patients with schizophrenia would benefit from clozapine — far more than the 4 percent who currently take it.“I have had many patients who were doing terribly, who struggled to function outside the hospital, and cycled through many medications,” he said. “If they go on clozapine, they really tend to not be hospitalized again. I’ve had people go on to finish college and work. It’s quite remarkable.”We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

The chair of the Covid inquiry has ruled that evidence related to PPE Medpro, the firm linked to Baroness Michelle Mone and her husband Doug Barrowman, will be heard in a closed, private session next month.

GenBioPro, a leading manufacturer of abortion medication, is preparing to go to battle with the Trump administration.The country’s largest manufacturer of abortion pills is wading into the first major legal battle over abortion of President Trump’s second term.The company, GenBioPro, on Tuesday asked a Texas court to add it to the list of defendants in a lawsuit filed in October by three Republican state attorneys general. The move was a significant offensive action on an issue seen as a vanguard in the fight over access to abortion.The lawsuit was filed by the state attorneys general from Missouri, Idaho and Kansas, and asks a federal court to reverse a series of Food and Drug Administration regulations that have greatly expanded access to the abortion pill mifepristone.Under the Biden administration, the Justice Department defended the agency’s rules and F.D.A.’s approval of the medication 25 years ago. But many abortion rights advocates anticipate that the Trump administration will decline to defend the agency, effectively siding with the state attorneys general and using the case to limit access.If the judge grants GenBioPro’s request, the maneuver will allow the company to lead the defense of mifepristone. The company is being represented by Democracy Forward, a legal nonprofit that has filed more than a dozen lawsuits and won multiple court orders against the Trump administration.“The foundation of these extreme politicians’ arguments are purely political, rather than based in scientific evidence,” said Skye Perryman, the president and chief executive of Democracy Forward. “The threat this case brings to abortion access nationwide cannot be understated.”We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

Republicans have proposed lowering the federal share of costs for Medicaid expansions, which could reshape the program by gutting one of the Affordable Care Act’s major provisions.House Republicans hunting for ways to pay for President Trump’s tax cuts have called for cutting the federal government’s share of Medicaid spending, including a proposal that would effectively gut the Affordable Care Act’s 2014 expansion of the program.Cutting Medicaid spending, which is central to the budget bill that House Republicans may bring to a vote on Tuesday, could result in millions of Americans across the country losing health coverage unless states decide to play a bigger role in its funding.Republicans are considering lowering the 90 percent share that the federal government is required to pay to states that enroll participants in the expansion. The change could generate $560 billion in savings over a decade, money that Republicans want to use toward extending Mr. Trump’s 2017 tax cuts, which are set to expire at the end of 2025. Extending the tax cuts is expected to cost $4.5 trillion, meaning Republicans will have to find savings beyond Medicaid from a long menu of options.A move to lower federal spending on the Medicaid expansion population could effectively gut the program. Around 10 states that have expanded their programs have so-called trigger laws that reverse the Medicaid expansion if the federal government decreases funding for the population.The change could leave the 40 states that participate in the Obamacare program with a difficult set of choices. They could shoulder the extra costs to preserve Medicaid coverage for millions, make cuts to coverage or look for cuts from other large government programs to offset the reduction in federal funds.Medicaid, which covers more than 70 million people, is the largest health insurance program in the nation, and the largest single source of funding for states. More than 21 million adults who were not eligible for Medicaid under pre-expansion guidelines received coverage last year. The program had previously restricted enrollment primarily to those who were pregnant, disabled or elderly.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

How government cuts are slowing research.The Trump administration stormed into office, loudly firing workers and closing diversity programs. But behind the scenes, it has also brought biomedical research to the brink of crisis by holding up much of the $47 billion the United States spends on the field every year.The world’s leading medical labs can be found in the United States, and they rely on grants from the National Institutes of Health. The agency has stopped vetting future studies on cancer, Alzheimer’s, heart disease and other ailments. Trump aides have said they just need time to review spending their predecessors had promised, but it’s unclear what they’re looking for at the N.I.H. or when scholars can expect to start receiving money again.In today’s newsletter, I’ll walk you through what happened — and why it matters.A complex machineLate last month, when the Trump administration froze government grants, a federal judge said it couldn’t just hold back money Congress had agreed to spend. But spending money at the N.I.H., which awards more than 60,000 grants per year, isn’t so simple.That’s because new grants endure a tortured bureaucratic process. The agency has to notify the public of grant review meetings in The Federal Register, a government publication. Then scientists and N.I.H. officials meet to discuss the proposals. The problem is that the Trump administration banned those announcements “indefinitely.” So new research projects can’t get approved.In effect, scientists say, the Trump administration is circumventing the court order. Health officials didn’t block research outright, but by shutting down the process, they’re still not spending much of the money Congress allocated to various research goals.The administration has also proposed other big changes, saying that universities should bear more of the “indirect costs” of research: maintaining lab space, paying support staff. Trump aides say the changes would trim administrative bloat and free up more government money for research.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

Amanda Pritchard, the first female chief executive of the NHS in England, is stepping down from the role.

2 hours agoCharlie BucklandBBC News

3 hours agoJane DeithBBC File on 4 Investigates

8 hours agoDominic HughesHealth Correspondent

The Food and Drug Administration has reinstated dozens of specialized employees involved in food safety, review of medical devices and other areas who were laid off last week, according to more than a dozen workers who got called back.The total number of employees recalled was not immediately clear. But a person familiar with the conversations said nearly all of the roughly 180 medical division employees who had been let go would get their jobs back. More than a dozen workers across a handful of teams said that they had received a call or email reinstating their employment; some reported that up to a dozen others on their teams had also been brought back.The F.D.A. and its parent agency, the Department of Health and Human Services, did not respond to requests for comment.The workers had been fired as part of the Trump administration’s efforts, led by Elon Musk, to significantly downsize the federal government and cut costs. But the salaries of many of the fired F.D.A. staff members had been funded by fees companies pay the F.D.A., not taxpayer money.Many of the reinstated jobs were financed by those kinds of fees, but some such employees were still out of work. Those whose job were funded by an excise tax on cigarettes, for example, said they were not called back to work over the weekend. Those workers reviewed applications for new tobacco products and studied the safety of emerging tobacco products, including e-cigarettes and devices that heat up tobacco but do not burn it.On Friday, The New York Times featured the accounts of laid-off staff members who reviewed the safety of surgical robots, cardiovascular devices and diabetes-care systems that infuse insulin. All had their jobs back as of Monday morning.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.