Decision time on Califf

Presented by the Coalition for Affordable Prescription Drugs (CAPD): Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Feb 15, 2022 View in browser   By Lauren Gardner and David Lim Presented by the Coalition for Affordable Prescription Drugs (CAPD) With Katherine Ellen Foley, Alice Miranda Ollstein and Adam Cancryn On Tap — The Senate is expected to vote today on Robert Califf's nomination to be FDA commissioner. — Covid-19 vaccines for kids under 5 now won't be available until later this spring at the earliest. What happened? — FDA authorized a new monoclonal antibody Friday that retains activity against the Omicron variant. It's Tuesday. Welcome back to Prescription Pulse. Did you have a favorite Health Policy Valentine? 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): New polling shows that Americans aren't fooled by Big Pharma. Voters clearly know that big drug companies are responsible for high drug prices. More than that, they want Congress and the Administration to take immediate action to protect patients by addressing the problem at its root: the high and rising prices set by Big Pharma. Learn more.   In Congress CALIFF FACES FINAL TEST IN SENATE — The Senate is set to vote to confirm Califf to lead FDA today at noon EST after a squeaker of a cloture vote Monday night. The 49-45 vote to limit debate was helped along by some convenient Republican absences — Shelley Moore Capito (R-W.Va.), Lindsey Graham (R-S.C), John Hoeven (R-N.D.), John Kennedy (R-La.) and Pat Toomey (R-Pa.). Based on your morning hosts' conversations with senators in recent weeks, some of those Republicans could end up on the "aye" side of the ledger at the final vote. White House principal deputy press secretary Karine Jean-Pierre told reporters on Monday Califf has met or is scheduled to meet with at least 47 senators. HHS Secretary Xavier Becerra and Biden counselor Steve Ricchetti are also making calls to Senate offices on Califf's behalf. "We are confident Dr. Califf will be confirmed with bipartisan support and urge the Senate to confirm him tomorrow," Jean-Pierre said. Just minutes later, Sen. Joe Manchin (D-W.Va.) took to the Senate floor to urge his colleagues to do the opposite, sharing the story of a young woman from his home state of West Virginia who died of a fentanyl overdose during the pandemic while isolating after a possible Covid exposure. Manchin said Califf's past tenure leading the agency showed he wouldn't take regulators in a new direction on opioid approvals, a point he also made in a Friday USA Today op-ed with Sen. Mike Braun (R-Ind.). "Dr. Califf has shown us who he is, and he has shown a complete lack of interest in actually making the difficult decisions we need the leader of the FDA to make," Manchin said on the floor. Anti-abortion groups assemble: Students for Life had been organizing a lobbying day, with activists flown to Washington from across the country, for later this week to try to convince more Republican senators to reject Califf. But after the early scheduling of the vote caught them off guard, they instead conducted a last-minute lobbying blitz by phone on Monday — thanking Sen. Roger Marshall (R-Kan.) and others who had already decided to vote no over Califf's record on abortion pills and urging them to stand their ground, while petitioning Sen. Rob Portman (R-Ohio) and others who remained on the fence. Coronavirus FDA DELAYS PEDIATRIC VAX MEETING — FDA announced Friday afternoon it would postpone a meeting of its independent vaccine advisers — initially scheduled for today — after receiving new information from Pfizer and BioNTech on their Covid-19 vaccine candidate for children under 5. The plan had been to consider authorizing a low-dose version of the shot as a two-dose series to jump-start the immunization process for the youngest children, the last segment of the population to become eligible for a Covid vaccine, while the companies evaluated a third dose after trial results suggested that was needed to ensure optimal protection from the virus. Peter Marks, FDA's top vaccine regulator, avoided offering many specifics about what in Pfizer's data prompted the agency to hit the brakes on the meeting, which had only been announced two weeks before. But his brief comments to media Friday signaled that the sheer number of pediatric Covid cases caused by the Omicron variant skewed whatever read of the data regulators had not that long ago. "What I can say is, the data that we saw made us realize that we needed to see data from a third dose as in the ongoing trial in order to make a determination that we could proceed with doing an authorization," Marks said. More on the delay: The delay came after extensive discussions Thursday between senior FDA officials and Pfizer over the company's vaccine data, which ultimately resulted in the agreement to hold off on the meeting, two people with knowledge of the matter told POLITICO's Adam Cancryn. They said they were reassured that the delay wasn't the result of any safety concerns — which would mean the data didn't show enough of a benefit to justify authorizing two vaccine doses without solid evidence that a third would yield the antibody response expected to protect babies and toddlers. But the decision, which Pfizer abruptly announced with FDA not far behind, caught many in the White House and HHS by surprise, touching off a scramble to figure out what had spurred the change of plans. CDC: BOOSTERS PREVENT HOSPITALIZATION BUT WANE AFTER FOUR MONTHS — Adults with mRNA boosters were less likely to be hospitalized for Covid-19 during the Omicron variant wave, even as some protection wanes after four months, a CDC study published Friday found. FDA AUTHORIZES NEW MONOCLONAL ANTIBODY — FDA authorized Eli Lilly's monoclonal antibody bebtelovimab on Friday, stating that it "retains activity" against the Covid-19 Omicron variant. Eye on FDA FDA RELEASES 2021 GENERIC DRUG REPORT — FDA approved or tentatively approved 776 generic drugs, many of which could help treat Covid-19, and issued nearly 1,800 complete response letters, the Office of Generic Drugs announced as part of its 2021 annual report. "COVID-19 related submissions included more than 75 original ANDAs, some which we approved in record time, as well as more than 1,200 supplemental applications," Sally Choe, the director of OGD, said in an accompanying blog. MEDICAL DEVICES UNPAID MQSA USER FEES RISING — The number of firms that have not paid invoices for the Mammography Quality Standards Act user fee program grew from about 3 percent in fiscal year 2020 to 7 percent in fiscal year 2021, an FDA spokesperson told POLITICO. Electronic billing was instituted for the program in April 2021. "This could be due to, in part, the continued impact of the COVID-19 pandemic as well as the need to obtain accurate email addresses for implementing the electronic billing process," the spokesperson said. FDA POSTS SECOND ESSURE INTERIM ANALYSIS — FDA on Monday released the second round of interim results from a postmarket surveillance study of Essure, a discontinued permanent sterilization device, now that all patients in the study have completed one year of follow-up. "Because the patients in the study are at different points in their follow up, the results presented are the overall interim study results from all patients thus far. Five-year follow-up of patients in the study is ongoing," the FDA update states. "The next interim analysis of study results is planned after all patients complete three years of follow-up."   A message from the Coalition for Affordable Prescription Drugs (CAPD):   Pharma Moves A number of moves in the HHS comms office: Kamara Jones will become the department's principal deputy assistant secretary for public affairs. She was previously deputy assistant secretary for strategic planning. Kelly Langford is joining HHS as online communications director after serving as senior principal for NGP VAN and as director of online fundraising for President Joe Biden's 2020 campaign. Ilse Zuniga is joining the department as press secretary for principal engagement after serving as press secretary to Sen. Tim Kaine (D-Va.). Pharma Worldwide SINGAPORE HEALTH AUTHORITY AUTHORIZES NOVAVAX VACCINE — The Singapore Health Sciences Authority issued interim authorization for Novaxax's Covid-19 vaccine on Monday. Several regulators across the globe have authorized the vaccine for use already. Novavax asked FDA in late January to authorize it for the U.S. Inside AgencyIQ Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. FDA sends revised supply chain guidance to White House — Last week the FDA sent a revised draft guidance on pharmaceutical verification systems to the White House's Office of Information and Regulatory Affairs for review . The guidance document is meant to explain how companies can comply with provisions of the 2013 Drug Supply Chain Security Act, a law which sought to implement a "track and trace" system to guard against counterfeit drugs. One of the ways the law sought to accomplish this is through the creation of a robust "verification system" to determine if products are authentic and how to handle inauthentic products (i.e., quarantine, destruction). The FDA published an initial draft guidance document on how pharmaceutical companies and drug wholesalers could create and maintain such a system in 2018, but some industry groups said the guidance was confusing (i.e., wasn't clear about how to differentiate between a "suspect" product and an "illegitimate" product). Other groups such as PhRMA said that requests for product verification, which the FDA said should be responded to within 24 hours, may be infeasible and should warrant flexibility. OIRA reviews typically take between several weeks and several months, depending on the complexity of the guidance. Document Drawer FDA will hold a virtual meeting to discuss a hiring and retention assessment conducted by Booz Allen Hamilton on March 15 at 9 a.m. EST. A message from the Coalition for Affordable Prescription Drugs (CAPD): Americans aren't fooled by Big Pharma. According to new polling, 80% of Americans want Congress to rein in big drug companies' skyrocketing prices. American voters clearly know that big drug companies bear responsibility for high drug prices and are looking to Congress and the Administration to take immediate action to protect patients. Learn more.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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