| | | | | |  | | By David Lim and Katherine Ellen Foley | | | | | | | 
The FDA is potentially facing a shortage of workers as employees consider retiring. | Sarah Silbiger/Getty Images | FDA GRAPPLES WITH RETIREMENTS — Many FDA employees who felt they could not leave federal service during the Covid-19 pandemic are starting to think about retirement and other plans, Julie Tierney, FDA chief of staff, told the Alliance for a Stronger FDA on Monday. The number of full-time employees has grown year over year from a little over 17,000 people in fiscal 2017 to more than 19,000 today. And the agency has made headway this year — about 2,000 new full-time employees have been brought on — but a little over 2,000 vacancies are still left to fill. The agency’s staff retirement worries, though, bump up against its retention challenges. Approximately 634 people departed the agency between October and May, and the agency continues to have difficulty being financially competitive with industry salaries. “In terms of our losses, about 38 percent of those are retirements,” Tierney said. “I know personally, anecdotally, a lot of people hung in through the pandemic. We had folks that were very mission-driven and felt like they couldn’t leave the agency during that important moment in time and now have started to reflect and think about retirement and other plans.” Improving hiring: The agency is working to reduce how long it takes to extend a job offer after managers decide they want to bring a job candidate on board. Competing with high-dollar industry salaries remains a difficulty for the agency, she said. “It's hard to ask people to take the type of salary cuts that we do unless they're really committed to being here,” Tierney said.
| | POLITICO’s Health Care Summit on Wednesday, June 7, will explore how tech and innovation are transforming health care and the challenges ahead for access and delivery in the U.S. Register now. | | IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE. Will we see you at POLITICO’s Health Summit on Wednesday? We hope so! Send news, tips and what you’ll be watching for to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with Robert King about his interview with Medicare Director Meena Seshamani and her approach to charting her path in drug price negotiations. Robert also discusses Seshama's professional background and how it could be bringing both a clinical and economic perspective to her role.
| | | | | A message from Optum Rx: Community and independent pharmacies play a vital role in people’s health care, especially for people living in rural and underserved communities. That’s why Optum Rx is proud to partner with more than 26,000 community pharmacists to deliver care, improve the pharmacy experience and help make prescription drugs more affordable. Learn more. | | | | | | | 
The FDA's CBER head, Peter Marks, discussed Covid vaccine advisory committees at the BIO International Convention on Monday. | Jim Lo Scalzo/Pool via AP | FDA HAS COVID AD COMM REGRETS — Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, said Monday that he’s not sure advisory committee meetings on the benefits and risks of whether the agency should have authorized the Covid-19 vaccines bolstered the public’s confidence, as he intended. “It’s important to have public discussion, but unfortunately … oftentimes what happened there was we had academic discussions that I think were very hard for the public to follow,” he told a panel moderated by Katherine at the BIO International Convention in Boston. Marks, the nation’s top vaccine regulator, acknowledged there was some uncertainty around the new Covid vaccines, but the high-level debate among researchers sometimes “led the public to think that we really didn’t know what was going on, when that really wasn’t the case.” Marks also said that in future pandemics or public health emergencies, combining meetings of the FDA and CDC vaccine advisory committees might be more effective. “There were two shots on goal for chaos to occur … when the honest truth was there was more agreement than churn.” “It's just a thought, and I just think something we need to think about [in the pandemic setting],” he added.
| | | | GET READY FOR GLOBAL TECH DAY: Join POLITICO Live as we launch our first Global Tech Day alongside London Tech Week on Thursday, June 15. Register now for continuing updates and to be a part of this momentous and program-packed day! From the blockchain, to AI, and autonomous vehicles, technology is changing how power is exercised around the world, so who will write the rules? REGISTER HERE. | | | | | | | | | GSK: FOCUS ON ADULT VACCINES — Executives from GSK told reporters Monday that a critical focus of the company’s future will be developing and getting FDA approval of combination immunizations for adult respiratory diseases. The company has a handful of adult immunizations on the market already. The FDA approved its shingles vaccine in 2017 and its respiratory syncytial virus vaccine for adults 60 and older last month. The company is working on Phase I trials of next-generation Covid and Covid-flu combination-shot vaccines with its partner CureVac. It’s also working to develop pneumococcal vaccines capable of protecting adults against different virus strains. The challenge ahead is convincing adults to get the shots. According to data from GSK and pharma data consultant IQVIA, adult vaccinations for CDC-recommended immunizations in 2022 were 14 percent below 2019 pre-pandemic levels. Only about 30 percent of eligible individuals have gotten the shingles vaccine, which is widely available and covered by Medicare and most private insurers. That’s why it’s important for pharma companies to focus on vaccines that target multiple virus strains or combine multiple immunizations, said Philip Dormitzer, GSK’s global head of vaccine research and development. “The key challenge for [developing] a multivariate flu vaccine is to have one that not only works but is well tolerated,” said Dormitzer.
| | | | A message from Optum Rx:   | | | | | ANOTHER SHORTAGE — Several health care facilities across the U.S. are grappling with shortages of specialized tourniquets, the FDA said in a Monday letter to health care providers. Localized disruptions in the supply of nonsterile, single-use pneumatic tourniquet cuffs used for limb surgeries and serious emergencies are the result of a recent recall. In March, medical device company Stryker initiated a recall for some of its tourniquet cuffs because of an increase in reported low-pressure events, which “may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications.” More than 102,000 devices were affected by the voluntary recall, according to the FDA. The agency recommends that facilities reuse tourniquets after cleaning them if new single-use devices are unavailable. The FDA expects the shortage to be resolved by the end of the year.
| | STATES SETTLE WITH SUBOXONE MAKER — Indivior, the manufacturer of opioid addiction treatment Suboxone, agreed on Friday to a $102.5 million deal with 41 states and the District of Columbia to settle claims it engaged in product-hopping, a practice in which a brand drug company tweaks its product from one formulation to another to slow competition. “We take our role as a responsible steward of medications for addiction and rescue extremely seriously,” Indivior CEO Mark Crossley said in a press release. “Resolving these legacy matters at the right value allows us to further this mission for patients.”
| | The Biotechnology Innovation Organization elected Ted Love as its new board chair for a two-year term.
| | | | DON’T MISS POLITICO’S HEALTH CARE SUMMIT: The Covid-19 pandemic helped spur innovation in health care, from the wide adoption of telemedicine, health apps and online pharmacies to mRNA vaccines. But what will the next health care innovations look like? Join POLITICO on Wednesday June 7 for our Health Care Summit to explore how tech and innovation are transforming care and the challenges ahead for access and delivery in the United States. REGISTER NOW. | | | | | | | | | Richard Pazdur, director of FDA’s Oncology Center of Excellence, said he wants to continue to have advisory committee panels vote on medical product recommendations, STAT’s Angus Chen reports. FDA Commissioner Robert Califf has indicated he favors having ad comm meetings focus on discussion instead of votes.
| | The FDA released final guidance Monday aimed at helping drugmakers evaluate the immunotoxic potential of a drug product. The FDA released final guidance for drug and biologic manufacturers that outlines the agency’s thinking on whether a drug-drug interaction study is needed when a therapeutic protein is involved. The FDA issued final guidance outlining expectations for cover-letter attachments for abbreviated new drug applications and controlled correspondence.
| | A message from Optum Rx: Optum Rx, a pharmacy care services company, is taking action to support community and independent pharmacies and the important role they play on the front lines of care to drive better health outcomes and identify unmet needs for the patients they serve.
• Pharmacy Solutions: Reducing administrative burdens to improve outcomes and ensure pharmacists are paid fairly.
• Predictability: Providing greater predictability of reimbursements for prescription drugs and improved analytics.
• Enhanced Reimbursement: Creating increased revenue opportunities for community pharmacies that help expand access to care, connect patients to services that address unmet needs such as food, nutrition, transportation, housing, and baby supplies, and improve medication adherence and health outcomes for their underserved and rural patients.
Community and independent pharmacies play a vital role in health care and supporting their expanded role as health care providers is more important than ever. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
Comments
Post a Comment