| | | | |  | | By David Lim and Lauren Gardner | Presented by the Pharmaceutical Care Management Association (PCMA) | With Katherine Ellen Foley
| | | — The CDC updated its Covid-19 vaccine dosing guidance, advising providers that some individuals could wait eight weeks between their first and second messenger RNA shots. — FDA on Tuesday released a long-awaited proposal to align medical device quality management system requirements with an international standard. — Democrats and Republicans are diverging over what was once a shared priority — funding medical research. It's Wednesday. Welcome back to Prescription Pulse. What's going on in the commissioner's office now that permanent political leadership is back? Remember to tip your newsletter-tenders generously. Send those tips and feedback 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): Over the past half decade, brand pharmaceutical manufacturers have undertaken a massive campaign to deflect blame for their pricing decisions. Ironically, the industry that controls the list price of prescription drugs has attempted to point the finger at those focused on reducing the cost of prescription drugs for patients and payers. We urge Congressional negotiators to continue to resist the latest attempts to shift the blame that puts profits over patients. | | | | | | CDC UPDATES SPACING GUIDANCE FOR DOSES — The CDC updated its website Tuesday to adopt its advisers' endorsement earlier this month of a longer dosing interval between primary series mRNA shots for certain individuals. An eight-week period between first and second doses "may be optimal" for certain people, the agency says, especially males ages 12 to 39 given the risk of myocarditis after the Pfizer and Moderna vaccines. The online update came after advisory committee members and agency staff indicated they needed to determine whether a change could come through clinical guidance or a more formal rulemaking. Emerging data shows a longer period between the primary series shots may bolster vaccine effectiveness and immune response while lessening the risk of heart-related side effects. The CDC still recommends the current interval — three weeks for Pfizer, four weeks for Moderna — for people 65 and older, the immunocompromised and "others who need rapid protection due to increased concern about community transmission or risk of severe disease." RURAL HOSPITALS AVOID BRAIN DRAIN FROM VAX MANDATE — Rural hospital officials say a mix of staff education and religious exemptions has helped them keep nearly all health care workers subject to Covid vaccine mandates on the job, POLITICO's Megan Messerly writes. About two dozen rural and state hospital leaders said they've lost a sliver of their staff to the federal requirement, which mandated that health care workers in every state except Texas receive at least one vaccine dose by last week. That means the mandate hasn't spurred the worst-case scenario — a staffing shortage that compromises care in rural areas — predicted by red-state governors and GOP lawmakers. States like Virginia and West Virginia are still seeking flexibility on the rule's enforcement in rural facilities as they grapple with longstanding recruitment and retention issues. But some rural hospital leaders warn that two separate standards for hospitals depending on where they're located could create an unlevel playing field for both employment and care. HOSPITAL-ACQUIRED COVID CASES HIT RECORD IN JANUARY — More than 3,000 hospitalized patients each week in January had caught Covid sometime during their stay, more than any point of the pandemic, according to federal data analyzed by POLITICO's Rachael Levy and Allan James Vestal. The data demonstrates both Omicron's virulence and hospitals' shortcomings in preventing in-house transmission two years into the pandemic. E25BIO RECALLS COVID TESTS — E25Bio initiated a recall in late January of more than 73,000 unauthorized rapid Covid-19 tests that were marketed and distributed in the U.S., FDA announced Friday. The agency issued a safety communication on Feb. 4 warning consumers not to use the tests, some of which contained labeling "that misrepresents the test as FDA-authorized." FDA published a new webpage on Tuesday that lists authorized at-home tests, which consolidates labeling information like whether tests should be used serially. See the list here.
| | | FDA ISSUES LONG-AWAITED PROPOSAL TO ALIGN DEVICE REGS — The FDA on Tuesday issued a proposed rule formally proposing to align certain medical device quality management system requirements with an international standard: International Organization for Standardization 13485:2016. "ISO 13485 specifies requirements for a QMS that can be used by a manufacturer involved in one or more stages of the life cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, or provision of associated activities," the proposed rule states.
| | | DEMS, GOP SPAR OVER ARPA-H PROPOSAL — Bipartisan support for one of President Joe Biden's top health priorities is splintering over concerns about costs and structure , a reflection of a widening fissure between the parties on funding medical research, POLITICO's Sarah Owermohle reports. Acrimony toward federal scientists like Anthony Fauci, plus the recent departure of Biden's science adviser Eric Lander over abusive workplace accusations, have stoked resistance within the GOP. And Democrats continue to wrestle with whether the proposed agency should be folded under the NIH umbrella or stand on its own.
| | | ANIMAL HEALTH LABS SEEK OUT DIAGNOSTIC SUPPLIES — Recent cases of Highly Pathogenic Avian Influenza detected in birds across several states including Maine, New York, Virginia and Indiana have prompted some animal health labs to seek additional diagnostic testing supplies. Many testing supplies used for PCR testing, like pipette tips, have been in high demand due to the Covid-19 pandemic. "We see an increased demand, it's not drastic like what we have seen obviously with Covid," Qiagen CEO Thierry Bernard told POLITICO. "If the numbers continue to grow we will probably develop a food animal avian flu assay on digital PCR. At the moment, we don't see that much of an increase." No human infections of avian flu have been detected in the U.S., according to the Agriculture Department. USDA National Animal Health Laboratory Network spokesperson Lyndsay Cole said there have been "minor issues with supplies due to national supply chain issues," but noted that labs have shared materials and alternative vendor information has been distributed. "Currently the NAHLN laboratories are reporting that they have adequate supplies to respond to HPAI, however, we will continue to monitor the situation with the NAHLN labs and the vendors," Cole said.
| | | | A message from the Pharmaceutical Care Management Association (PCMA):   | | | | | | GATES OUTLINES PLAN TO TACKLE FUTURE PANDEMICS — Countries should get to decide how to prioritize vaccine distribution to optimize benefits for their populations, philanthropist Bill Gates told POLITICO's Erin Banco on the sidelines of the Munich Security Conference. That, plus a focus on strengthening health systems in poor nations, would help combat both Covid and the next pandemic, he said. AFRICA CDC TO ASK WORLD TO PAUSE COVID-19 VACCINE DONATIONS — The Africa CDC plans to ask for Covid-19 vaccine donations be paused until the third or fourth quarter of this year, the director of the agency told POLITICO's Daniel Payne. John Nkengasong, director of the Africa Centers for Disease Control and Prevention, said the primary challenge for vaccinating the continent is no longer supply shortages, but the logistical challenges of getting shots into arms in a timely manner and overcoming vaccine hesitancy. VACCINE ADVOCACY GROUPS PRESS BIDEN TO BREAK WTO DEADLOCK — Vaccine advocacy groups are pressing President Joe Biden to help break a nearly two-year-old deadlock at the World Trade Organization by embracing South Africa and India's demand for a broad waiver of intellectual property right protections for Covid-19 vaccines, tests and treatments, POLITICO's Doug Palmer reports. The call comes as the WTO General Council is expected to discuss the issue this week and again fail to come to a conclusion.
| | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. Accelerated approval in the spotlight — The FDA's accelerated approval program has existed since 1992, but now, in its 30th year, the program is under an unprecedented level of scrutiny from Congress, the public and the FDA itself. According to AgencyIQ's analysis, there are ten major trends to watch in 2022 related to Accelerated Approval. For Prescription Pulse readers, we have an abbreviated summary of those trends:
- FDA is beginning to crack down on companies that fail to complete confirmatory studies required as a condition of marketing, such as through its "Project Confirm."
- Some sponsors are choosing to withdraw Accelerated Approval products rather than be subject to additional scrutiny, and the FDA is increasing its efforts to remove other products from the market.
- The next user fee program proposes changes to Accelerated Approval, including moving up discussions about post-approval confirmatory studies to at least 6-8 weeks prior to approval and the use of real-world evidence to support post-approval requirements.
- FDA wants reforms to Accelerated Approval. Richard Pazdur, the influential head of the Oncology Center of Excellence, has spoken about his preference that the Accelerated Approval pathway be reformed to make it easier for the FDA to remove products from the market. FDA also commissioned a report, Optimizing the Use of Accelerated Approval, detailing potential reforms.
| | | FDA issued a warning letter to drug company CytoDyn after finding the company's former chief executive touted the benefits of its investigational monoclonal antibody, leronlimab, for Covid-19 patients. The drug is still under FDA review. CytoDyn's board removed Nader Pourhassan, who made the comments in a public video from Sept. 2021, in January.
| | | | A message from the Pharmaceutical Care Management Association (PCMA): Over the past half decade, brand pharmaceutical manufacturers have undertaken a massive campaign to deflect blame for their pricing decisions. Ironically, the industry that controls the list price of prescription drugs has attempted to point the finger at those focused on reducing the cost of prescription drugs for patients and payers. We urge Congressional negotiators to continue to resist the latest attempts to shift the blame that puts profits over patients. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
Comments
Post a Comment