FDA combatting field mice at White Oak campus

Presented by the Pharmaceutical Care Management Association (PCMA): Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Apr 12, 2022 View in browser   By Lauren Gardner, David Lim and Katherine Ellen Foley Presented by the Pharmaceutical Care Management Association (PCMA) On Tap — Field mice have taken up residence in a handful of buildings at FDA headquarters. — CDC's independent vaccine advisers will meet next week to discuss Covid boosters. — FDA's food safety office fails consumers, a POLITICO investigation finds. It's Tuesday. Welcome back to Prescription Pulse. Katherine's excited about her flowers that have started blooming — maybe yours have, too? Send tips, feedback, secrets and pics of your garden 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).   A message from the Pharmaceutical Care Management Association (PCMA): In the fight to make prescription drugs more affordable, PBMs are the only part of the prescription drug supply and payment chain dedicated to lowering drug costs for patients. In fact, PBMs are lowering patient prescription drug costs by nearly $1,000 every year, enabling safe and seamless prescription drug delivery to patients, and helping patients stay on their medications. Get the full story and learn more about how PBMs advocate for patients at OnYourRxSide.org.   The creatures are stirring at FDA where some field mice have moved in. | Andrew Kelly/Reuters/Alamy WHEN THE WORKERS ARE AWAY, THE MICE WILL PLAY — Who among us hasn't left a half-eaten afternoon snack stashed away in our desk? Your morning hosts can't pretend to be above such an office-etiquette faux pas. Alas, FDA employees are just like us. The agency confirmed to Lauren and David that it's grappling with a field mouse problem in some of its White Oak campus buildings, which was exacerbated by workers leaving food at their desks while they largely worked from home the past two years. "It is accurate that food products left behind in offices when maximum telework was implemented is a contributing factor to offices with pest control issues," FDA spokesperson Stephanie Caccomo said. Less than 10 percent of office building space is affected, she said, and mice have been found inside the Office of the Commissioner, the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health. It all started with a mouse: But two former agency officials said FDA's sprawling Silver Spring, Md., campus has long had an issue with mice, dating back to at least President Barack Obama's first term. FDA began consolidating its federal real estate footprint in the early 2000s, taking over the former Navy site at White Oak and rebuilding office and lab space. One former official said staff attributed the mice problem in the early 2010s to that construction, given the campus' otherwise bucolic environment. Its persistence, the official said, is yet another headache for FDA employees who have faced unprecedented workloads during the pandemic. "I know they're contemplating transitioning back, but nothing will kill morale [like] opening your desk after two years and finding evidence of mice," the person said. Other woodland creatures have apparently been spotted inside agency headquarters, according to at least two FDA alumni. "When I worked at White Oak there were frogs everywhere. I found a tiny one going through security in building 66," device safety expert Madris Kinard tweeted. "When I was at FDA, we had a problem with garden snakes that we found in the building," former commissioner Scott Gottlieb tweeted. "We got rid of the snakes, and look what happens…" FDA IS FAILING TO MEET CONSUMERS' EXPECTATION FOR FOOD SAFETY — A POLITICO investigation by Helena Bottemiller Evich found that food regulation by FDA is plagued by inaction and structural failures. Through more than 50 interviews, Evich uncovered that power struggles paralyze food regulators' ability to keep dangerous contaminants out of baby formula and water, leading to severe illness and even death. Murray calls on Califf to take action in response: Sen. Patty Murray (D-Wash.), chair of the Senate Health, Education, Labor and Pensions Committee, authored a letter to FDA Commissioner Robert Califf on Monday, citing the POLITICO report. She asked Califf what steps he will take to improve food safety, whether he has determined why there have been delays in addressing food-safety concerns and how he will improve the structural organization of food regulators. She also asked for a report on how many food-safety inspections the agency has conducted and how many packages the agency sampled for toxins in the last decade. Califf has until April 25 to respond. CDC SCHEDULES BOOSTER MEETING FOR ADVISERS — The CDC's Advisory Committee on Immunization Practices will meet on April 20 to discuss Covid-19 booster shots, agency spokesperson Kristen Nordlund told Lauren. An agenda is not yet available, but the panel likely will revisit much of what FDA's own external vaccine advisers hashed out last week, especially the question of who should receive boosters and when. SELECT COMMITTEE SEEKS GIROIR, KADLEC INTERVIEWS — Chair of the Select Subcommittee on the Coronavirus Crisis Jim Clyburn (D-S.C.) requested documents and transcribed interviews from Trump-era HHS Assistant Secretary for Health Brett Giroir and former Assistant Secretary for Preparedness and Response Robert Kadlec as part of the committee's investigation into the government's response to the Covid-19 pandemic. "The Select Subcommittee has collected extensive evidence showing that you were the main official responsible for the revision of the Centers for Disease Control and Prevention (CDC) testing guidance issued in August 2020 so that it stated — contrary to the prevailing scientific consensus — that individuals exposed to the virus did not necessarily need to get a test," Clyburn wrote to Giroir.   SUBSCRIBE TO NATIONAL SECURITY DAILY : Keep up with the latest critical developments from Ukraine and across Europe in our daily newsletter, National Security Daily. The Russian invasion of Ukraine could disrupt the established world order and result in a refugee crisis, increased cyberattacks, rising energy costs and additional disruption to global supply chains. Go inside the top national security and foreign-policymaking shops for insight on the global threats faced by the U.S. and its allies and what actions world leaders are taking to address them. Subscribe today.     Around the Agencies HHS: WE NEED MORE DATA ON KRATOM — Proponents of kratom as a supplement that shouldn't be scheduled as a drug are pointing to a letter HHS Secretary Xavier Becerra penned to lawmakers last month as evidence the department is backing off of an aggressive approach to the plant. In the March 16 letter to Rep. Mark Pocan(D-Wis.) and Sen. Mike Lee(R-Utah), Becerra says HHS believes it needs more data to understand kratom's public health impact with respect to therapeutic use and safety concerns. "Discussions continue within HHS on mitigating actions to best address the various public health concerns presented, including potential unintended consequences that may arise from transitioning to riskier alternatives (for example fentanyl) if kratom were to be scheduled," he wrote. Mac Haddow, a senior fellow on public policy at the American Kratom Association, said the letter represents a "significant departure" from federal regulators' previous posture on the substance, particularly FDA. Becerra said NIH and FDA are backing studies on kratom's pharmacology. "That's not a group that's ready to proceed with scheduling," Haddow said. HHS didn't respond to requests for comment. CMS SEEKS INPUT ON NURSING HOME STAFFING RULE, PROPOSES INFECTION-CONTROL MEASURE — The Centers for Medicare and Medicaid Services is seeking information on how to improve safety at long-term care facilities, POLITICO's Rachael Levy reports. In a proposed rule, the agency outlines a new measure to evaluate infections residents acquire at facilities and assess homes based on the way they control those outbreaks. It also proposes a way to evaluate the facilities based on staff turnover and requests comments on the optimal staffing level.   STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president's ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.     In Congress GRASSLEY, WARREN WANT QUICK HEARING AID FINAL RULE — Sens. Elizabeth Warren(D-Mass.) and Chuck Grassley (R-Iowa) last week introduced legislation, S. 4043 , directing FDA to issue a final rule that enacts a framework to allow over-the-counter hearing aids within 30 days of being signed into law. MEDICAL DEVICES FDA: MISUSE OF IMAGING SOFTWARE RISKS MISDIAGNOSIS — FDA on Monday asked health care providers to review the limitations of radiological computer-aided triage and notification devices for intracranial large vessel occlusion — a blockage in a major artery in the brain, which can lead to stroke — noting the devices are intended to be used for only prioritization and triage, not diagnostic decisions. "Information from real-world use suggests that providers may not be aware of the intended use of these devices," FDA wrote in its letter . "If LVO CADt devices are not used as intended, there is the potential for misdiagnosis resulting in patient injury or death."   A message from the Pharmaceutical Care Management Association (PCMA):   Industry Intel BIONTECH ANNOUNCES PARTNERSHIP WITH MATINAS PHARMACEUTICALS — BioNTech and the New Jersey-based Matinas BioPharma have entered an exclusive agreement to collaborate on messenger RNA vaccines beyond BioNTech's Covid-19 inoculation in partnership with Pfizer, the companies said Monday. They have begun a licensing agreement for Matinas' lipid nanocrystal technology, which could be used with BioNTech's vaccine development — including oral candidates. Pharma Moves Illumina has hired John Frank as its chief public affairs officer. Jorge Gomez joins Moderna as chief financial officer. He was previously the executive vice president and chief financial officer at Dentsply Sirona, a dental equipment company. Pfizer has brought on David Denton as chief financial officer and executive vice president. Denton joins Pfizer from Lowe's Companies, where he was also chief financial officer and executive vice president. The American Medical Association has hired Kirsten Bibbins-Domingo as the next editor-in-chief of the Journal of the American Medical Association and JAMA Network. QUICK FIX Drug companies and Alzheimer's patient advocacy groups fear that CMS' coverage decision for Aduhelm will lead to stalled research, POLITICO's Megan Wilson reports. FDA's former foods and veterinary medicine deputy commissioner Michael Taylor believes it's time for food safety to occupy an entirely separate agency, he writes in a POLITICO op-ed. Document Drawer FDA issued two product-specific guidances on Friday that outline performance criteria for surgical sutures and orthopedic fracture fixation plates seeking 510(k) clearance through the agency's safety and performance-based pathway.   A message from the Pharmaceutical Care Management Association (PCMA): Pharmacy Benefit Managers, PBMs, are working on behalf of 266 million Americans with health insurance to reduce prescription drug costs, expand access to medications, and improve patient outcomes. Here are the key facts to know about PBMs: · PBMs negotiate with drug companies to lower prescription drug costs, reducing patient drug costs by nearly $1,000 each year. · PBMs work with pharmacies to deliver prescription drugs to patients safely and seamlessly. · PBMs help patients stay on their prescription drugs to live healthier lives. · PBMs advocate for patients in the fight to keep prescription drugs accessible and affordable. Learn how PBMs advocate for patients at OnYourRxSide.org.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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