| | | | |  | | By Chelsea Cirruzzo and Ben Leonard | | | With help from Megan R. Wilson
| | |  Rep. Morgan Griffith, the E&C Oversight and Investigations Subcommittee chair, intends to hold additional hearings on the FDA’s foreign inspections. | Drew Angerer/Getty Images | WHAT AMOUNTS TO AN INVITE? A House subcommittee hearing on the FDA’s foreign inspections was overshadowed by debate Tuesday about why the FDA wasn’t there to testify, POLITICO’s David Lim reports. “Completely unacceptable,” Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) said of the FDA’s no-show. Republicans said the agency was invited to testify about two weeks ago. An FDA spokesperson said the agency didn’t receive a “timely or formal” invite. And CJ Young, spokesperson for Democrats on the E&C Committee, said Republicans unfairly slammed the FDA. “The [GOP] majority chose to informally notify FDA about this hearing without sufficient notice to attend,” Young said. “It’s unfortunate that Republicans are more interested in scoring political points than actually working together to ensure the health and safety of the American people.” To be continued … Virginia Republican Morgan Griffith, chair of the E&C Oversight and Investigations Subcommittee, said he plans to hold additional hearings on the topic — and urged the agency to testify. “If the FDA does not come willingly, we have other means to secure their attendance,” Griffith said. What about inspections? Lawmakers from both parties urged the FDA to boost its foreign inspections, especially in India and China, which account for the lion’s share of drug and drug ingredient imports. Lawmakers also urged the agency to conduct more unannounced visits to manufacturing plants abroad. The number of foreign inspections peaked at 3,277 in 2019, dropping to 265 in 2021 amid the Covid-19 pandemic. The FDA has ramped back up: 2,321 last year, according to an FDA database. During the pandemic, the FDA turned to remote inspections to help bridge the gap. “My concern is you can’t see on a Zoom the rats scurrying on the floor,” Griffith said, adding that he is not against remote inspections. But drugmakers “are not likely to show you the documents in a bin being destroyed with acid.” The FDA is overhauling its Office of Regulatory Affairs, an effort that might get more inspectors in the field, said John Claud, an FDA attorney at Hyman, Phelps & McNamara who testified at the hearing. WELCOME TO WEDNESDAY PULSE. The FDA is expected to soon unveil a proposal to ban formaldehyde in certain hair products, but some say it’s too little, too late. Send your tips, scoops and feedback to ccirruzzo@politico.com and bleonard@politico.com and follow along @ChelseaCirruzzo and @_BenLeonard_.
| | | | A message from the Coalition to Protect America's Health Care: Who Puts Patients First – And Who Pursues Profits By Limiting Access to Care? https://protecthealthcare.org/latest/who-cares-for-you | | | | | | | 
As the number of syphilis cases rises in the U.S., the CDC has issued syphilis testing and treatment guidelines. | Frederic J. Brown/AFP via Getty Images | CDC ISSUES SYPHILIS TESTING GUIDE — Amid a “syphilis epidemic,” the CDC released recommendations Tuesday on testing for the sexually transmitted infection, Chelsea writes. “Limited point-of-care tests for syphilis are available in the United States; increased availability of point-of-care tests that are sensitive and specific could facilitate expansion of screening programs and reduce the time from test result to treatment,” the agency wrote. The recommendations highlight the types of tests providers can use to identify an infection quickly and the timelines to follow for testing. Background: More than 207,000 reports of syphilis were reported to the CDC in 2022, though that’s likely a significant undercount given testing challenges. A rise in congenital syphilis, when the infection passes from a parent to their child during birth, has especially alarmed officials. According to the CDC, a lack of adequate treatment and timely testing accounted for 88 percent of congenital syphilis cases in 2022. Despite the recommendations, public health departments nationwide worry that continued budget cuts threaten the ability to provide comprehensive testing — particularly for rapid tests — which the CDC notes in its guidance. A top treatment option made by Pfizer has also faced shortages, making it hard to get. Also at the agency — The CDC’s latest antismoking campaign focuses on the harms of menthol cigarettes, while at the same time, a federal ban on the product stalls. The agency announced the campaign this week to encourage smokers to quit, featuring seven prior smokers, including five who used menthol cigarettes. The Food and Drug Administration was slated to ban menthol cigarettes last year, years after its tobacco advisory committee concluded the cigarettes disproportionately harm Black Americans, but White House officials confirmed the ban has been delayed until later this year.
| | | | CONGRESS OVERDRIVE: Since day one, POLITICO has been laser-focused on Capitol Hill, serving up the juiciest Congress coverage. Now, we’re upping our game to ensure you’re up to speed and in the know on every tasty morsel and newsy nugget from inside the Capitol Dome, around the clock. Wake up, read Playbook AM, get up to speed at midday with our Playbook PM halftime report, and fuel your nightly conversations with Inside Congress in the evening. Plus, never miss a beat with buzzy, real-time updates throughout the day via our Inside Congress Live feature. Learn more and subscribe here. | | | | | | | | CBO CHANGES AFOOT? The House Budget Committee unanimously advanced legislation to reform how the CBO handles estimates of preventive health care, Ben reports. Many in the industry and Congress have grumbled that the CBO’s estimates don’t sufficiently reflect potential long-term savings from preventive care. The legislation would require CBO to weigh whether a bill would save money over a 30-year budget window, as opposed to 10, if Congress asks it to. The bill from Reps. Michael Burgess (R-Texas) and Diana DeGette (D-Colo.) advanced in a 30-0 vote. It comes as lawmakers seek ways to reduce health care costs. “This legislation will finally help bend the cost curve and provide a more accurate understanding of long-term cost savings from preventive health policies,” Burgess said. “An ounce of prevention is worth a pound of cure. We are asking that CBO, which has only looked at the cost of the ounce of prevention, now give us a score for the pound of cure that is going to result.” A CBO spokesperson told Pulse it doesn’t have a cost estimate on the bill yet. CBO says it measures preventive care’s impact on increased longevity, disease reduction and early detection. It also takes into account adverse effects like overdiagnosis.
| | | | A message from the Coalition to Protect America's Health Care:   | | | | | RELIGIOUS ANTI-DISCRIMINATION — HHS officials are trying to avoid complaints against hospitals and long-term care facilities by explaining how to abide by visitation rules without discriminating based on religion. Why it matters: HHS’ Office for Civil Rights told Pulse it received numerous complaints and questions during the pandemic about a patient’s right to receive visitors free from discrimination on the basis of religion. The complaints have included pandemic policies that allowed visits from family members but not clergy. Last month, OCR released an FAQ and a Dear Colleague letter to hospitals and long-term care facilities impacted by regulations on religious anti-discrimination. Under CMS rules, those facilities can’t limit visitation based on race, gender, sexuality, disability or religion, including during a public health emergency when visitation can be restricted for clinical reasons. Facilities must have written visitation policies. The agency also gave other examples of complaints, like hospitals preventing family members from bringing patients Kosher or halal food while allowing other outside food items and hospitals subjecting members of certain religious groups to more rigorous screening processes.
| | | | DON’T MISS POLITICO’S GOVERNORS SUMMIT: Join POLITICO on Feb. 22 to dive into how Governors are wielding immense power. While Washington remains gridlocked, governors are at the center of landmark decisions in AI and tech, economic development, infrastructure, housing, reproductive health and energy. How are they setting the stage for the future of American politics, policies and priorities? How are they confronting major challenges? Explore these questions and more at the 2024 Governors Summit. REGISTER HERE. | | | | | | | | | Stuart Portman is now Medicaid director in Georgia. He previously was senior health policy adviser on the Senate Finance Committee. Myoung Cha is now chief product officer at Alphabet’s research company Verily, replacing Dr. Amy Abernethy, who stepped down last month. Cha previously was head of health strategic initiatives at Apple. Geralyn Ritter is now president and CEO of government relations and public policy firm Crowell & Moring International. She previously was executive vice president of corporate affairs, sustainability and ESG at Organon & Co., a global health care company.
| | STAT reports on the Supreme Court’s plans this month to weigh in on whether Covid misinformation is considered free speech. The Washington Post reports on a possible link between cognitive decline and polycystic ovary syndrome, a hormonal disorder that affects women.
| | | | A message from the Coalition to Protect America's Health Care: A new infographic from the Coalition to Protect America’s Health Care lays out the facts about who puts patients first and who pursues profits by limiting access to care. See the head-to-head comparison: https://protecthealthcare.org/latest/who-cares-for-you | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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