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Presented by the Pharmaceutical Care Management Association: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By David Lim , Lauren Gardner and Katherine Ellen Foley | Presented by the Pharmaceutical Care Management Association | With help from Alice Miranda Ollstein
| | | — President Biden has contracted Covid-19. The treatment landscape has changed dramatically since President Trump was ill in 2020. — Reagan-Udall Foundation and other outside experts to evaluate key FDA offices, including those focused on tobacco regulation and food safety. — CDC endorses Novavax's vaccine, providing another option for unvaccinated adults. It’s Friday. Welcome to Prescription Pulse. Stay hydrated, folks. 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 Pharmaceutical Care Management Association: PBMs are working to lower patient costs for insulin. But the INSULIN Act will increase insulin costs while giving drug manufacturers another way to game the system to maximize profits. Drug manufacturers alone set insulin prices. Rather than increasing pharma’s profits, Congress should take on drug companies by addressing the root cause of high insulin costs: their price setting.
PBMs support reducing insulin costs for patients. Learn more about PBM efforts to lower insulin costs. | | | | | | | 
Biden says he's "doing great" after testing positive for Covid-19. The White House said Biden is experiencing "very mild symptoms," including a stuffy nose, fatigue and cough. He's taking Paxlovid, an antiviral drug designed to reduce the severity of the disease. | Adam Schultz/The White House via AP | BIDEN TESTS POSITIVE — Biden’s positive Covid test Thursday sent a jolt through Washington, no matter the seeming inevitability that he, too, would eventually catch an illness that’s affected millions of Americans. Unlike the last time a sitting president came down with the disease , the treatment profile for Covid is robust, and Biden is not at risk in the same way as Donald Trump was , POLITICO’s Daniel Payne writes. Biden immediately began taking Paxlovid, an antiviral regimen the administration has sought to promote, thanks to its high efficacy rate. Biden is also fully vaccinated and twice-boosted, a key development that gives him baseline protection against severe disease and hospitalization that Trump did not have as vaccines weren’t yet available. Another treatment effective against the Omicron variant that Biden could potentially receive is bebtelovimab, a monoclonal antibody that received emergency use authorization from the FDA in February for treatment of mild-to-moderate Covid-19 in people ages 12 and older at high risk for severe disease. A note from Biden’s doctor on his diagnosis did not mention that option as part of the president’s treatment but noted that he’d provide updates on “any changes in his condition or treatment plan.” CDC ENDORSES NOVAVAX VACCINE — Rochelle Walensky, director of the Centers for Disease Control and Prevention, recommended the two-dose Novavax vaccine for unvaccinated adults on Tuesday , Katherine reports. Walensky’s endorsement came hours after the agency’s external advisory committee voted 12-0 to recommend the vaccine. The need for a Novavax booster …: Some vaccine advisory committee members were concerned that Novavax is not yet available as a booster. For now, people who receive the Novavax vaccine — who were either resistant to receiving a messenger RNA-based vaccine or were medically unable to — must receive an mRNA booster. “There will be an urgency for those who do receive the Novavax vaccine to have some FDA comment also on the booster doses,” said Pablo Sánchez, a professor of pediatrics at Ohio State University and voting committee member. … and fall boosters: “There could be some kind of anticipated timeline for the late summer and fall,” said Camille Kotton, an associate professor of medicine at Harvard Medical School. “Some people are asking if they can get a booster dose now … or if they should wait,” she added, noting that the confusion may cause delays in shots getting into arms. BIDEN ADMIN TO ELEVATE ASPR WITHIN HHS — Biden officials are elevating HHS’ pandemic and disaster response office in hopes of addressing gaps exposed during the Covid pandemic, POLITICO’s Sarah Owermohle and Erin Banco write. The decision would make the Office of the Assistant Secretary for Preparedness and Response its own operating division, putting it on par with directors of other major departments, like the CDC and the FDA.
| | | | A message from the Pharmaceutical Care Management Association:   | | | | | | FDA CAN CONTINUE NORMAL OPERATIONS UNTIL NOVEMBER, BURR SAYS — The FDA has enough carryover funds from its user fee programs to maintain normal operations through the start of November, Senate HELP ranking member Richard Burr (R-N.C.) told reporters Tuesday . The carryover funds may allow the FDA to delay issuing pink slips for several weeks rather than at the beginning of August as some feared. A Senate HELP Committee aide told POLITICO the FDA is set to brief staffers Friday afternoon on the carryover balance state of play. The Congressional Budget Office on Thursday released a score of the user fee package advanced out of the Senate HELP Committee, which the independent experts estimate will save nearly $1.4 billion over 10 years if passed into law. But significant cost-saving provisions in the Senate legislation that aim to increase generic drug competition could be left out of the package after Burr last week introduced a stripped-down bill that only reauthorizes the user fee agreements. HOUSE PASSES CONTRACEPTION BILL — The House on Thursday passed a bill, H.R. 8373 , which would protect someone’s ability to access and use contraception and would protect a health care provider’s ability to provide birth control methods. Eight Republicans supported the bill, which passed 228-195 with unanimous Democratic support. INTO THE BYRD BATH WE GO — The Senate Parliamentarian began hearing arguments Thursday evening on the drug pricing language in Democrats' long-stalled reconciliation bill, but a ruling on whether key provisions can pass with fewer than 60 votes isn't expected until well into the weekend or early next week, our Alice Miranda Ollstein reports. Sen. Mike Crapo (R-Wy.), the top Republican on the Finance Committee, confirmed to reporters this week that his team is going through the bill "line by line" and plans to "go to the Parliamentarian with every Byrd challenge that we can find." But most Capitol Hill aides and outside experts say the provision most at risk of getting knocked out of the bill is the inflation cap for people on private insurance. FDA FUNDING HOPS ON HOUSE MINIBUS — The House passed a six-bill spending package on Wednesday that would include $3.66 billion in fiscal 2023 discretionary funding for the FDA, POLITICO’s Jennifer Scholtes reports. Senior lawmakers are still working out a broader funding deal, making a continuing resolution extending current levels past Sept. 30 likely. Notable amendments: The chamber adopted a couple of amendments indicating lawmaker interest in pet agency issues. One led by Rep. Abigail Spanberger (D-Va.) would direct some funding to finalize a proposed rule on direct-to-consumer TV ads for pharmaceuticals, and another led by Rep. Bryan Steil (R-Wis.) would shift $5 million to the Center for Drug Evaluation and Research from other offices “to combat the illicit importation of opioids, including fentanyl, through international mail facilities and land ports-of-entry.”
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U.S. Food and Drug Administration Commissioner Robert Califf testifies during a Senate HELP Committee hearing. | Jose Luis Magana/AP Photo | FDA ENLISTS EXTERNAL GROUP TO REVIEW FOOD, TOBACCO UNITS — FDA Commissioner Robert Califf said Tuesday that his agency commissioned the Reagan-Udall Foundation and other unnamed experts to review the offices related to food safety, tobacco regulation and inspections, Katherine reports. The announcement comes as the agency faces increasing congressional and public scrutiny and criticism over its role in the infant formula shortage and the regulation of electronic cigarettes . In addition to food safety and vape turmoil, a source with direct knowledge of the Office of Regulatory Affairs said that a slew of people have recently left the office — some as they take planned retirement and others as they have been fed up with organizational issues and inadequate pay. “As of July 2022, ORA has 35 vacant human and animal food investigator positions for which the FDA is actively recruiting. Without continuing initiatives like direct hiring authority and without incentives for retention, we expect to be challenged to maintain our current staffing levels and rate of inspections,” an agency spokesperson told Prescription Pulse. WHITE HOUSE LAYS OUT MONKEYPOX RESEARCH AGENDA — The White House announced Thursday a $140 million, 22-target research agenda for monkeypox to better understand and handle rising case counts across the country, POLITICO’s Daniel Payne reports . MORE MONKEYPOX VACCINES REACH NYC — On Wednesday, New York City health department announced 26,000 doses of the monkeypox vaccine are in transit after being stuck in Denmark, POLITICO’s Amanda Eisenberg reports. As of Tuesday, more than 700 people in the city had tested positive for the virus. CALIFF SAYS FDA FINISHING MONKEYPOX VACCINE REVIEW — Califf announced Thursday that the agency is in the process of completing its review of monkeypox vaccines being shipped to the U.S. to ensure they work as expected. “This involves more than just paperwork. It’s necessary work to help ensure the safety, quality and performance of the vaccines,” Califf tweeted . “While FDA works to finish our scientific review relevant for these doses, we are allowing them to be shipped right away, with the necessary documentation to follow soon after.” “We always have to consider the fact that FDA has information that they can't release publicly by law,” Trump-era FDA Commissioner Stephen Hahn told POLITICO. “I'm pretty confident that the folks in the [Office of Regulatory Affairs] as well as the commissioner's office are making this decision based upon the best available evidence."
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| | | Sens. Maggie Hassan (D-N.H.) and Rand Paul (R-Ky.) wrote a letter to Commissioner Califf asking for the FDA to clarify whether public health organizations are cleared to distribute naloxone . Chair of the Congressional Black Caucus Health Braintrust Robin Kelly (D-Ill.) and the majority of CBC members wrote Commissioner Califf a letter in support of the FDA’s proposed rule banning menthol cigarettes . The Pew Charitable Trusts, AdvaMedDx, Friends of Cancer Research and other groups sent a letter on Wednesday to lawmakers, advocating passage of legislation overhauling regulation of lab tests and diagnostics.
| | | | A message from the Pharmaceutical Care Management Association: America’s pharmacy benefit managers (PBMs) support lower insulin costs, and have taken steps to reduce out-of-pocket costs for patients relying on insulin.
The INSULIN Act won’t lower insulin costs. It gives Big Pharma companies another way to game the system to maximize profits. Rather than lining pharma’s pockets, Congress should take on manufacturers to reduce costs: increasing competition among insulin manufacturers and stopping patent abuses that block generic and biosimilar insulins from reaching the market for patients to use.
It’s simple. Insulin prices are high because there are only a few insulin manufacturers, shielded from competition, and those companies set and raise prices. PBMs, on the other hand, are the only entity in the prescription drug supply and payment chain dedicated to reducing drug costs. On average, PBMs reduce patient drug costs by nearly $1,000 every year.
Learn more about how PBMs are working to lower insulin costs. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
