| | | | |  | | By Lauren Gardner and David Lim | Presented by Pharmaceutical Care Management Association | With Megan R. Wilson and Erin Schumaker
| | |  Federal officials are confident that they can handle a response if bird flu becomes a threat to humans. | Justin Sullivan/Getty Images | AVIAN FLU STATE OF PLAY — ICYMI on Friday, David landed a scoopy story outlining U.S. preparedness for a potential avian flu outbreak in humans and what the government would need to escalate a response. Federal officials are confident in their ability to respond if the need should arise. But, as Dawn O'Connell, HHS assistant secretary for preparedness and response, said, that “doesn’t mean America gets vaccinated tomorrow.” I asked David what he’s monitoring as the virus makes its way through the nation’s cattle herds: Have U.S. officials offered an idea of what would trigger the next level of response for the U.S.? At what point would they begin rolling out treatments or shots? CDC Director Mandy Cohen told me that certain thresholds would trigger a heightened level of response — for example, if public health authorities saw additional sporadic human infections or a more severe case. If human-to-human transmission was suspected, diagnostic testing would become even more important. During the Covid-19 pandemic, commercial labs stepped in to help augment public health lab capacity. Another step would be to ensure that flu antivirals are still effective against avian flu, and candidate vaccines are targeted to the correct strain of the virus. How many people is the U.S. actually prepared to vaccinate? The candidate vaccines that the government believes are a good match for the circulating strain would take two shots to fully administer — meaning that the supply of doses for each tranche is smaller than it appears. Initially, hundreds of thousands of doses in prefilled syringes could be available within weeks if the FDA granted emergency use authorization, O'Connell told me. Then, vaccines in bulk storage could be filled and finished into vials or syringes — a step that could be completed within three or four months. The government has just under 10 million doses that could be deployed at this stage. Finally, if the government activated standing contracts with flu manufacturers, 125 million doses could be deployed within 130 days, O’Connell said. How much emergency funding might the government need if it were to step up its response? If the government started to use avian influenza vaccines, it would quickly need emergency funding to support the second and third stages of deployment. Sources told me if more funding is put toward the effort, vaccine production could be sped up and the amount produced could increase. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Dr. David Egilman, who often appeared as an expert witness when pharma companies went to trial, died Monday at 71. Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim).
| | | | A message from Pharmaceutical Care Management Association: Pharmacy Benefit Managers (PBMs) work to provide patients with a higher quality, lower cost pharmacy experience, which includes supporting independent pharmacies in rural areas nationwide through innovative programs to increase reimbursements on prescription drugs and expanding payments for clinical services. Learn more about PBM support for rural pharmacies and patients. | | | | | | | 
The FDA doesn't expect to receive the $8 million it requested to better implement its regulatory powers over the cosmetic industry. | Mark Lennihan/AP | ‘COSMETIC’ IMPROVEMENTS — The FDA doesn’t anticipate receiving the level of appropriations that Congress authorized when it handed the agency greater authority over cosmetics in 2022 — as much as it would like to see a windfall, an agency official said Monday. Lawmakers authorized $26 million for fiscal 2024 and about $42 million for fiscal 2025 for the FDA to implement its new regulatory powers, which include mandatory recalls of harmful products and adverse event reporting. “This was far more than what the agency expects to receive through the budget process,” Dr. David Strauss, the FDA’s acting chief scientist, said during a budget webinar hosted by the Alliance for a Stronger FDA, which advocates for more appropriations for the agency. “It is tricky to have expanded authorities and to have no new resources to enforce those authorities.” The ask: The FDA seeks $8 million in fiscal 2025 for its cosmetics work, Strauss said, a small boost to the $7 million it got this year. If the FDA received additional funding, he said, the agency would hire more staff “for continued strategic coordination and implementation,” including experts to manage projects like the mandatory assessment of the use of manmade chemicals known as PFAS in cosmetics. A report on the results is required by the end of 2025. “With more resources, we’re able to do things in a more timely manner,” Strauss said. Inflation conundrum: Congress did not provide a funding bump in fiscal 2024 to cover inflation raises for workers throughout the agency, FDA CFO Benjamin Moncarz said, warning that the shortfall hurts recruitment and hampers professional development opportunities. The FDA has asked for $115 million for fiscal 2025 to cover pay inflation. “This funding increase is critical to make sure we can continue serving the public in an exceptional manner,” he said.
| | | | THE GOLD STANDARD OF POLICY REPORTING & INTELLIGENCE: POLITICO has more than 500 journalists delivering unrivaled reporting and illuminating the policy and regulatory landscape for those who need to know what’s next. Throughout the election and the legislative and regulatory pushes that will follow, POLITICO Pro is indispensable to those who need to make informed decisions fast. The Pro platform dives deeper into critical and quickly evolving sectors and industries—finance, defense, technology, healthcare, energy—equipping policymakers and those who shape legislation and regulation with essential news and intelligence from the world’s best politics and policy journalists.
Our newsroom is deeper, more experienced, and better sourced than any other—with teams embedded in the world’s most active legislative and regulatory power centers. From Brussels to Washington, New York to London, Sacramento to Paris, we bring subscribers inside the conversations that determine policy outcomes and the future of industries, providing insight that cannot be found anywhere else. Get the premier news and policy intelligence service, SUBSCRIBE TO POLITICO PRO TODAY. | | | | | | | | CALIFF ON THE HILL ONCE MORE — FDA Commissioner Robert Califf is slated to make his second appearance on Capitol Hill in two weeks to defend his agency’s budget request for fiscal 2025. The Thursday appearance before the House Appropriations Subcommittee in charge of FDA funding comes as the agency seeks an increase of $157 million in budget authority over fiscal 2023 levels. PSYCHEDELICS MARKUP — The House Veterans’ Affairs Subcommittee on Health will mark up a bill Tuesday afternoon directing the VA secretary to produce a report for Congress within 180 days of the FDA approving a psychedelic drug. Sponsored by Republican Reps. Derrick Van Orden of Wisconsin and Jack Bergman of Michigan, who are proponents of further research into whether psychedelics could treat intractable mental illnesses, the bill would require the secretary to justify any decision to include, or not include, the newly approved or licensed psychedelic among the drugs the VA offers to veterans. Big picture: The FDA is considering Lykos Therapeutics’ application for talk therapy combined with MDMA, also known as ecstasy, as a treatment for post-traumatic stress disorder, which disproportionately affects veterans. The FDA granted Lykos’ application priority review and set an Aug. 11 target date for deciding whether to approve it.
| | | | A message from Pharmaceutical Care Management Association:   | | | | | VA DEMS PREP FOR CONTRACEPTION SHOWDOWN — Virginia Democrats who sponsored legislation to create an enforceable right to contraception in the state will urge their colleagues this week to return the bill to GOP Gov. Glenn Youngkin’s desk in its original form. The legislature will reconvene Wednesday to consider Youngkin’s vetoes and amendments of myriad bills, including a proposed change to the contraception rights bill that essentially makes it an unbinding policy statement. The bill’s advocates delivered to the governor’s mansion earlier this month more than 37,000 signatures of Virginians who support the original measure. “I think he owes it to his constituents — a full and proper response,” said Democratic state Sen. Ghazala Hashmi. “Is he going to stand on the side of … extremists who reject that fundamental right to privacy?”
| | | | POLITICO IS BACK AT THE 2024 MILKEN GLOBAL CONFERENCE: POLITICO will again be your eyes and ears at the 27th Annual Milken Institute Global Conference in Los Angeles from May 5-8 with exclusive, daily, reporting in our Global Playbook newsletter. Suzanne Lynch will be on the ground covering the biggest moments, behind-the-scenes buzz and on-stage insights from global leaders in health, finance, tech, philanthropy and beyond. Get a front-row seat to where the most interesting minds and top global leaders confront the world’s most pressing and complex challenges — subscribe today. | | | | | | | | | Drugmaker Takeda hired Rebecca Mandell to serve as its director of federal affairs. She comes from Organon, where she launched the federal government relations operation following its spin-off from Merck. Jeremy Gowler is now interim CEO at Invivyd while the company’s board searches for a permanent successor to Dave Hering. Corinne Le Goff has joined Viatris as chief commercial officer. She previously was president and CEO of Imunon, a clinical-stage biotech, and did stints at Moderna and Amgen.
| | | | A message from Pharmaceutical Care Management Association: PBMs work on behalf of health plans and patients to reduce drug costs, support access to quality pharmacy care, and enable better health outcomes in every community, especially rural communities.
While PBMs are working every day to reduce drug costs for patients, PBMs are also committed to working with pharmacies to support patients’ access to prescription drugs. In rural communities, PBMs are offering innovative programs to support increasing pharmacy reimbursements including expanding reimbursements for clinical services performed at rural independent pharmacies for rural patients. A strong relationship between PBMs and rural pharmacies means a better experience and more affordability for patients.
Each year, PBMs save patients and the U.S. health care system an average of $1,040 per person. Without PBMs, employers and health plans would be forced to go it alone on pharmacy benefits, which would result in significantly higher drug costs for patients.
Learn more. | | | | | A Chinese company that some members of Congress want to prevent U.S. biotechs from partnering with makes some or all of the main ingredients in blockbuster drugs treating conditions like cancer and obesity, The New York Times reports. The number of new prescriptions for a Humira biosimilar, a cheaper version of a pricey rheumatoid arthritis treatment, jumped to 36 percent from 5 percent in early April thanks to CVS’ growing control over the prescription drug market, STAT reports.
| | The Government Accountability Office published a review of various state regulations on pharmacy benefit managers. The FDA issued marketing denial orders for 65 “MNGO Disposable Stick” e-cigarettes in flavors such as tobacco, menthol, pink lemonade, strawberry mango, watermelon freeze and iced banana. The FDA is establishing a Center for Clinical Trial Innovation within its drugs center as a hub “that supports innovative approaches to clinical trials that are designed to improve the quality and efficiency of drug development and regulatory decision making.” | | | | Follow us on Twitter | | | | Follow us | | | | |
No comments:
Post a Comment