| | | | |  | | By David Lim and Katherine Ellen Foley | Presented by the Coalition for Affordable Prescription Drugs (CAPD) | | | | — FDA is convening its vaccine advisory committee on April 6 to discuss Covid-19 booster shots. — The U.S. is not adequately maintaining its testing capacity, worrying White House officials, diagnostic manufacturers and public health experts. — Don't put Covid-19 at-home test liquid solution into your eyes, FDA warns. It's Tuesday. Welcome back to Prescription Pulse. Instead of venturing out to the Tidal Basin to enjoy the Cherry Blossom peak bloom this week, we suggest enjoying Hains Point or the National Arboretum to avoid the crowds. Send 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 Coalition for Affordable Prescription Drugs (CAPD): A new report finds that rebates do not result in higher drug prices. This new data offers clear evidence refuting drug companies' claims that the rebates PBMs negotiate are to blame for increasing list prices for brand drugs and shows that price trends in rebated and non-rebated drugs were comparable over the last four years. Don't be fooled by Big Pharma: their prices are the problem. Learn more. | | | | | | FDA VACCINE ADVISERS SET DATE TO DISCUSS COVID-19 BOOSTERS — FDA's vaccine advisory committee will meet April 6 to discuss additional Covid-19 booster shots for adults, Katherine reports. The all-day virtual meeting is set to discuss considerations for boosters and the best ways to select strains for the SARS-CoV-2 virus for future vaccines. Representatives from CDC and NIH will also attend. Expect a heated debate: "I don't expect that there will be clear consensus on who is [going to] need a booster because people will disagree about the goal of vaccination," said Leana Wen, an emergency physician and public health professor at George Washington University. While nearly everyone agrees the main reason for vaccination is to reduce severe illness, others disagree about whether Covid-19 vaccines should be evaluated as a prophylactic against all infection, she added. Data published by the CDC earlier this year showed that after two months, people who received messenger RNA boosters were 91 percent protected from hospitalization from Omicron and 87 percent protected from needing to visit an emergency department or urgent care center. But that protection waned after four months to 78 percent and 66 percent, respectively. Some of FDA's independent advisory committee will likely argue that any increased infection risk is enough to warrant recommending an additional booster, while others say the protection from hospitalization is sufficient. Missing from the meeting: The committee will not be discussing any particular vaccine application nor will it be voting. Last week, Pfizer and its partner, BioNTech, and Moderna asked FDA to authorize additional booster doses. Pfizer-BioNTech asked FDA to authorize boosters for those 65 and older, and Moderna asked the agency to authorize them for all adults. Setting the new tone: "Now is the time to discuss the need for future boosters as we aim to move forward safely, with Covid-19 becoming a virus like others such as influenza that we prepare for, protect against, and treat," Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, said in a statement.
| | | | 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. | | | | | | | | U.S. TESTING CAPACITY IN DANGER, WHITE HOUSE WARNS — White House officials, diagnostic manufacturers and public health experts are sounding the alarm that Covid-19 testing capacity built up during the Omicron wave could erode if Congress fails to authorize new funds and cases surge. The Biden administration estimates that the testing market will remain stable until early summer, but some manufacturers are already cutting back, David reports. "If we get to a point where companies really are turning off lines or laying off people — are not making investments in the Covid test market — and we have another surge, then we will not be ready to go," Tom Inglesby, White House senior adviser for Covid response, told POLITICO. "We will be in a situation that is potentially much worse than what we had with Omicron." Déjà vu: Covid-19 infections are on the rise in Europe, and testing manufacturers are shipping far fewer tests to the U.S. than just a few weeks ago. Scott Becker, the CEO of the Association of Public Health Laboratories, said the U.S. is repeating the same mistakes it made last summer when demand for testing plummeted and test manufacturers scaled back production. "It's like we've learned absolutely nothing as a system during this pandemic," Becker said. "I have no reason to believe that wouldn't happen again because they don't have the demand." Testing for the uninsured falling off a cliff: The White House plans to wind down the federal subsidies that guarantee free tests for uninsured people beginning today because of a lack of funding for the program. "Testing for the uninsured impacts about 30 million people in the United States," said Dan Lee, senior vice president of life sciences and growth at Covid-19 testing and sequencing company Helix. "You're gonna get less complete data. And unfortunately, it's less complete data in some of the places where you expect some of the highest transmission. So, we do expect that it will impact surveillance." What happens if cases surge again? "If we do see another big spike in cases, we're going to see the same exact thing happen with testing where it's going to take a while, at least three or four weeks for us to try and gear back up to meaningful capacity," said Mayo Clinic Laboratories president William Morice, who is also president of the American Clinical Laboratory Association board of directors. "It would be too late to do some of the things that they really want to do in terms of mitigating efforts."
| | | | A message from the Coalition for Affordable Prescription Drugs (CAPD):   | | | | | | FDA: DON'T SWALLOW AT-HOME COVID TEST LIQUID SOLUTION — People should take precautions to keep at-home Covid-19 test kits out of reach of children and pets because of potential harm if the packaged liquid solution is swallowed or comes into contact with the skin or eyes, FDA said Friday in a safety communication. "The liquid solutions may include chemical ingredients, such as sodium azide, that help the test work properly or act as preservatives," FDA said. "The test chemicals can be irritating or toxic if they get on your skin, nose, or eyes or if they are swallowed."
| | | FEDS SEEK COVID-19 HOSPITAL SAFETY COMPLAINTS FOLLOWING POLITICO REPORT — U.S. health officials are discussing how to ensure Americans file Covid-19 safety complaints, POLITICO's Rachael Levy reports. After POLITICO reported last week that some hospitals ask patients to remove their N95 masks, federal health officials became concerned that patients aren't aware of how to report hospital safety issues to regulators. The Centers for Medicare and Medicaid Services plans to notify hospitals that patients should be allowed to wear their N95s when entering and that they should work with state survey agencies about health care facility complaints.
| | | PFIZER TO SUPPLY UNICEF 4M COURSES OF COVID-19 ANTIVIRAL — Pfizer reached an agreement with UNICEF to supply 4 million courses of Paxlovid, its novel Covid antiviral, to 95 low- to middle-income countries, the company said Tuesday. Those countries can receive them at a not-for-profit price starting in April, pending authorization from their respective drug authorities. The company expects to be able to continue supplying courses of Paxlovid throughout the end of the year, pending countries' needs. TEVA AND ALLERGAN TO PAY RHODE ISLAND $28.5M IN OPIOID LAWSUIT — In a lawsuit settlement, Teva Pharmaceutical and AbbVie's Allergan agreed to pay Rhode Island a combined $28.5 million over 13 years for their role in the state's opioid epidemic. Additionally, Teva will provide the state with 50,000 kits of Naloxone, a nasal spray that can reverse opioid overdoses, and 67,000 30-pill bottles of Suboxone, used to treat opioid addiction, over the next decade.
| | | | DON'T MISS POLITICO'S INAUGURAL HEALTH CARE SUMMIT ON 3/31: Join POLITICO for a discussion with health care providers, policymakers, federal regulators, patient representatives, and industry leaders to better understand the latest policy and industry solutions in place as we enter year three of the pandemic. Panelists will discuss the latest proposals to overcome long-standing health care challenges in the U.S., such as expanding access to care, affordability, and prescription drug prices. REGISTER HERE. | | | | | | | | President Joe Biden on Monday warned U.S. companies to be on guard against Russian cyberattacks, POLITICO's Maggie Miller and Sam Sabin report. Biden urged companies to "harden your cyber defenses immediately." Surgeon General Vivek Murthy said on "Fox News Sunday" that a rise in Covid-19 infections in Europe should engender a new focus on "preparation, not on panic," POLITICO's David Cohen reports.
| | | FDA is holding a webinar today on its final guidance on patient engagement in clinical study design for medical devices at 1 p.m. EST.
| | A message from the Coalition for Affordable Prescription Drugs (CAPD): A new report finds that rebates do not result in higher drug prices. This new data offers clear evidence refuting drug companies' claims that the rebates PBMs negotiate are to blame for increasing list prices for brand drugs and shows that price trends in rebated and non-rebated drugs were comparable over the last four years. The report also highlights how rebates promote competition and lower insurance premiums. Don't be fooled by Big Pharma: their prices are the problem. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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