| | | | |  | | By Katherine Ellen Foley , David Lim and Lauren Gardner | Presented by The Pharmaceutical Care Management Association | | | | | 
Ex-FDA employees say the agency's vaccine inspection office staff is undertrained. | Sarah Silbiger/Getty Images | HOW TRAINING BROKE DOWN FOR THE FDA'S VACCINE INSPECTION TEAM — The level of training in the Food and Drug Administration's office that oversees licensed vaccines has decreased dramatically in recent years, raising concerns that the team is not equipped to identify quality-control issues that could potentially endanger consumers, POLITICO's Erin Banco reports. Team Biologics is a small operation of 13 to 16 inspectors responsible for inspecting licensed vaccine products, as well as cord blood, allergenic, gene and cell-therapy products. But in recent years, the agency hasn't provided new staff with the robust training required to identify missteps or abnormalities in manufacturing when visiting facilities — a problem that was exacerbated after a 2017 reorganization paired vaccine inspectors with those that specialized in blood and tissue products. At least nine inspectors have resigned — partly over the lack of training for new hires — and the agency has struggled to find experienced replacements. "Now, they've just moved some of these people over, like 'Oh, you do blood inspections, you can just come over and start doing drug [and vaccine] inspections,' which is ridiculous," one former inspector said. "That institutional knowledge of the manufacturing process is important." The former inspectors that Erin spoke with did not know of any instances in which Team Biologics accidentally missed a vaccine contamination or failed to report a manufacturing issue. But they're concerned about inspectors misidentifying a problem or overlooking a serious production issue if the lack of rigorous training and experienced team members persists. A similar issue of understaffed and undertrained inspectors on the food safety side of the agency contributed to the infant formula crisis this summer after a Michigan manufacturing plant reported that Cronobacter bacteria contaminated some of its product. Audra Harrison, a spokesperson for the FDA, said the inspectors on Team Biologics are "highly trained professionals" who produce thorough assessments of each facility during inspection. But ex-staff said they didn't feel they had enough agency support. "Not only were we supposed to cover and do the inspections, we were supposed to train them [ourselves]," a former inspector said of needing to help educate newer inspectors. IT'S WEDNESDAY. WELCOME TO PRESCRIPTION PULSE. Send tips, feedback and advice on biking in below-freezing temperatures to David Lim ( dlim@politico.com or @davidalim ), Lauren Gardner ( lgardner@politico.com or @Gardner_LM ) or Katherine Ellen Foley ( kfoley@politico.com or @katherineefoley ). TODAY ON OUR PULSE CHECK PODCAST , Ben Leonard talks with POLITICO's Erin Banco about her investigation into why the FDA team overseeing licensed vaccines is overwhelmed by high turnover and a backlog of inspections. Plus, Shawn Zeller has a preview of the Milken Institute's Future of Health Summit, which starts today.
| | | | | | | A message from The Pharmaceutical Care Management Association: During Diabetes Awareness Month, America's pharmacy benefit managers, PBMs, continue their specialized work helping diabetes patients take their drugs safely and affordably. With a PBM on her side, Kaeana's daughter, who lives with diabetes and a rare liver condition, gets her medications for $40 - not the $6,000 these prescription drugs would otherwise cost her. Hear Kaeana's Story. Learn more about how PBMs are working on behalf of all Americans living with diabetes. | | | | | | | 
President Joe Biden and his Pentagon chief oppose any effort to repeal the vaccine mandate for troops. | Ted S. Warren/AP Photo | BIDEN SUPPORTS KEEPING VACCINE MANDATE FOR TROOPS — President Joe Biden and his Pentagon chief oppose any effort to repeal the vaccine mandate for troops, POLITICO's Lara Seligman reports. The administration's position, announced Monday, could spell trouble for the National Defense Authorization Act, which House lawmakers will likely vote on this week . The $847 billion spending bill is expected to include a provision, championed by some Republican lawmakers, that would repeal the Covid vaccine mandate for members of the military or allow unvaccinated service members to remain in their positions. Though 98 percent of the armed forces have been vaccinated against Covid-19, thousands of troops have been released from military service for refusing the shot. PFIZER, BIONTECH SEEK VAX FORMULA CHANGE-UP FOR YOUNGEST KIDS — Pfizer and BioNTech have asked the FDA for emergency use authorization to make their bivalent vaccine formula the third dose in the primary series for kids ages 6 months through 4 years who have not yet been vaccinated, the companies said Monday. That would mark a different approach from how the updated formula — aimed at the original coronavirus strain and two Omicron subvariants — has been introduced to older populations as a single booster dose beyond the primary two-dose series. It's "expected" that children in that age group who are already fully vaccinated with the original vaccine "will not be eligible to receive a booster dose of any bivalent Covid-19 vaccine at this time," Pfizer spokesperson Sharon Castillo told Lauren. A potential reason why: Vaccination rates for young children have remained stubbornly low — 2.7 percent and 4.6 percent of the U.S. population of kids under 2 and kids 2 to 4, respectively, were fully vaccinated as of Nov. 30, according to the CDC.
| | | FIRST IN RxP: WARREN AGAIN PRESSES USPTO — Sen. Elizabeth Warren (D-Mass.) is asking Kathi Vidal, the director of the U.S. Patent and Trademark Office, for an update on work between the USPTO and the FDA to ensure the patent system for pharmaceutical drugs is working appropriately. The lawmaker expressed concern that the patent office "is not moving quickly or aggressively enough to combat abuses of the patent system." "We are glad that the USPTO is committed to evaluating how obvious type double patenting is contributing to the high cost of prescription drugs and we are interested in learning about the changes you will make to ensure this type of abuse ceases," Warren wrote on Monday in a follow-up to a previous letter.
| | | | GO INSIDE THE MILKEN INSTITUTE FUTURE OF HEALTH SUMMIT: POLITICO is featuring a special edition of our "Future Pulse" newsletter at the 2022 Milken Institute Future of Health Summit from Dec. 6 to 8. The newsletter takes readers inside one of the most influential gatherings of health industry leaders and innovators solving the biggest global health issues to ensure a healthier, more resilient future for all. SUBSCRIBE TODAY TO RECEIVE EXCLUSIVE COVERAGE . | | | | | | | | FDA UPDATES IMPELLA RP SYSTEM LABEL — On Monday, the FDA tightened the label for Abiomed's Impella RP (right-heart pump) System to reflect a post-approval study that found the heart device performed worse in patients who would not have qualified for the premarket study. The device performed similarly in the post-market study for those patients who met the enrollment criteria for the premarket study. "The FDA believes that when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP System continue to outweigh the risks," the FDA said in a letter to health care providers . "The FDA will continue to work with the manufacturer to monitor reports of adverse events for the Impella RP System and ensure that health care providers are informed about the intended use of the device." FDA TO HOLD MEETING ON DRUG SUPPLY CHAIN SECURITY ACT — Tomorrow and Thursday, the agency will host a public meeting on the final implementation of the Drug Supply Chain Security Act — a law passed 10 years ago intended to create interoperable, electronic tracing of certain prescription drugs. Over the next two days, stakeholders will discuss the final actions they need to take by Nov. 2023, when the law requires prescription drugs to be traceable from manufacturers to those who distribute drugs to patients. REAGAN-UDALL REPORT ON FDA'S FOOD PROGRAM TO PUBLISH TODAY — An independent panel from the Reagan-Udall Foundation is slated to publish its review of the FDA's food-safety operations today. The report, which FDA Commissioner Robert Califf called for in July amid scrutiny around the agency's response to the ongoing baby formula shortages, will likely propose major changes to the way the FDA oversees food safety.
| | | | A message from The Pharmaceutical Care Management Association:   | | | | | | Dan Leonard is vacating the presidency of the Association for Accessible Medicines. David Gaugh, the group's executive vice president of sciences and regulatory affairs, will take on the role of interim head.
| | | | POLITICO APP USERS: UPGRADE YOUR APP BY DECEMBER 19! We recently upgraded the POLITICO app with a fresh look and improved features for easier access to POLITICO's scoops and groundbreaking reporting. Starting December 19, users will no longer have access to the previous version of the app. Update your app today to stay on top of essential political news, insights, and analysis from the best journalists in the business. UPDATE iOS APP – UPDATE ANDROID APP . | | | | | | | | Express Scripts, Cigna's pharmacy benefit manager, will put multiple biosimilar versions of Abbvie's autoimmune drug Humira on its formulary in 2023, Bruce Jaspen reports for Forbes. Former FDA Commissioners Scott Gottlieb and Mark McClellan argue in STAT that Congress needs to update the FDA's authority to regulate diagnostic tests and grant the agency the authority to regulate cosmetics. The U.S. Court of Federal Claims ruled in late November that the federal government failed to notify Gilead of its patent applications for Truvada's use in pre-exposure prophylaxis (PrEP) promptly, Nicole DeFeudis writes for EndPoints.
| | | The FDA published final guidance on collecting safety data in late-stage preapproval or post-approval clinical trials.
| | | | A message from The Pharmaceutical Care Management Association: During Diabetes Awareness Month, America's pharmacy benefit managers, PBMs, continue their specialized work of helping diabetes patients get and take their prescription drugs affordably, conveniently and safely. Despite consistent manufacturer price increases on insulin products, PBM pharmacy experts help patients access and take medications as prescribed.
With a PBM on her side, Kaeana's daughter, who lives with diabetes and a rare liver condition, can obtain all of her medications for $40 – not the $6,000 these prescription drugs would otherwise cost her.
"Without help, we would be paying $6,000 a month for medication, but because we have a PBM, I'm only paying $40 out of pocket," Kaeana states. "It's very important to have access to affordable medication, because if we didn't, my child wouldn't be alive."
Hear Kaeana's Story and learn more about how PBMs are working on behalf of all Americans living with diabetes. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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