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Presented by Nomi Health: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Lauren Gardner, David Lim and Katherine Ellen Foley | Presented by Nomi Health | | | | — FDA’s outside vaccine advisers will consider Novavax’s bid to make a fourth Covid-19 vaccine for the U.S. — FDA user fee reauthorization appears to hit a speed bump in the Senate but is set to move forward in the House. — Emergent and Johnson & Johnson to split, each claiming the other violated their contract. It’s Tuesday. Welcome back to Prescription Pulse. The D.C. Public Health Lab on Saturday confirmed a positive orthopoxvirus case in a district resident who recently traveled to Europe. Samples have been sent to CDC for monkeypox testing. 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).
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Clinical trial participants are monitored during Novavax Covid-19 vaccine testing in Australia two years ago. Today, FDA advisers will decide whether to approve the shot. | Patrick Rocca/Nucleus Network/ABC via AP | DECISION TIME FOR NOVAVAX — Today marks a significant day for Maryland-based vaccine maker Novavax: FDA’s independent advisers will vote on whether to recommend the agency authorize its Covid-19 shot for emergency use in adults. But why does the U.S. need another Covid vaccine in its arsenal when nearly 77 percent of adults here are fully vaccinated? The benefits of having another vaccine technology have become clear with the diminished status ofJohnson & Johnson’s Covid vaccine . The Novavax vaccine could also be used by the small percentage of people allergic to a component in the messenger RNA offerings. But FDA’s evaluation of Novavax’s data raised two red flags when it was released on Friday, Lauren reports: a potential causal link to cases of heart inflammation and a lack of manufacturing data proving the company can consistently make a product that adheres to FDA’s high purity standards. “Multiple events of myocarditis/pericarditis were reported in temporal relationship to [Novavax vaccine] administration, similar to myocarditis following mRNA COVID-19 vaccines and raising concern for a causal relationship to” the Novavax vaccine, FDA said in its briefing document. The company said in a statement Friday it believes “there is insufficient evidence to establish a causal relationship.” Tom Shimabukuro, the head of CDC’s Immunization Safety Office, will give a presentation on vaccine-associated myocarditis this morning. FDA also said manufacturing data and product information for the vaccines Novavax intends to use under an EUA were still being tested and submitted when the agency conducted its review. Under FDA’s EUA guidance to manufacturers, applicants must ensure vaccine quality and consistency — a longstanding issue for Novavax — to receive authorization. PFIZER TO EXPAND MICHIGAN FACTORY FOR PAXLOVID — On Monday, Pfizer announced a $120 million investment in its Kalamazoo facility, which will support the production of components used in its Covid-19 therapeutic, Paxlovid. The increase will spur the creation of more than 250 jobs, the company said. CDC COVID MORTALITY DATA ON 2-WEEK PAUSE — CDC’s National Center for Health Statistics’ vital statistics system will undergo a two-week upgrade that will pause its Covid-19 surveillance data updates. Data updates are expected to resume on June 20.
| | | | A message from Nomi Health:   | | | | | | HOUSE MAY CONSIDER UFA BILL UNDER EXPEDITED RULE — The House appears poised to vote this week on H.R. 7667 (117) . The bill would reauthorize FDA’s medical product user fees under suspension of the rules, a speedy legislative process that would allow legislation to advance with two-thirds of the chamber present and voting. The potential procedure suggests leadership is confident members will back the measure, which won’t be open for floor amendments. SENATE UFA PACKAGE HITS SPEED BUMP — A Senate HELP Committee markup of the chamber’s own user fee reauthorization package might slip past the initially scheduled Wednesday date after an agreement on a manager’s amendment was not reached in time, two sources close to the negotiations told POLITICO. A GOP Senate HELP Committee aide separately pointed to ranking member Richard Burr (R-N.C.) as focusing on getting policies addressing the agency’s oversight of the infant formula crisis into the amendment. “The FDA continues to struggle with accountability,” the GOP aide said. “Addressing recent and systemic failures, including the creation of a baby formula shortage and the way that crisis has been handled, is essential if we’re considering expanding FDA’s responsibilities in these agreements.”
| | | | DON'T MISS DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED: Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today. | | | | | | | | EMERGENT, J&J TO MUTUALLY CUT TIES — Emergent BioSolutions, a specialty pharmaceutical manufacturing plant, and Johnson & Johnson have each accused one another of violating the terms of their contracts. The U.S. government had tasked Emergent with manufacturing millions of Covid-19 vaccines from AstraZeneca and Janssen, the Johnson & Johnson subsidiary. On Monday, Emergent notified Johnson & Johnson of a “material breach” of its contract. Emergent said that by winding down production of its Covid-19 vaccine and confirming it would not be purchasing the minimum of agreed-upon vaccines, Janssen could owe Emergent between $125 million to $420 million should it end the contract early, per an SEC filing. Johnson & Johnson on Monday formally told Emergent that it would dissolve their manufacturing agreement because of Emergent’s “failure to supply Covid-19 vaccine drug substance,” the company said in a statement. The company told Emergent on May 31 that it intended to break off the manufacturing agreement. Johnson & Johnson added that Emergent’s SEC filing form “is false and misleading both with respect to the contrived breach allegation against Johnson & Johnson and in its failure to disclose our prior notice that Johnson & Johnson would terminate the supply agreement.” Both companies have hit major potholes: In early May, FDA updated the authorization for Johnson & Johnson’s Covid-19 vaccine, restricting it to adults who were unwilling or unable to receive mRNA vaccines. FDA reviewed additional data and concluded the risk of developing thrombosis with thrombocytopenia syndrome, a rare but serious side effect of developing blood clots with low platelet counts, merited limiting the vaccine’s use in adult populations. In November 2021, the Biden administration terminated a $628 million contract with Emergent after the company had extensive problems scaling up vaccine production. A congressional investigation recently found that the company had to discard hundreds of millions of contaminated or low-quality doses of both Johnson & Johnson and AstraZeneca Covid-19 vaccines.
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Monkeypox cases are now confirmed in 12 states and the District of Columbia. | Centers for Disease Control and Prevention | U.S. PREPS FOR MORE MONKEYPOX — The United States ordered 36,000 more doses of Jynneos, a relatively new vaccine to fight monkeypox outbreaks, the HHS announced Monday, Daniel reports. The order comes as case counts in the U.S. continue to tick up, leading the agency to prepare for more cases and exposures that would increase demand for the shot. As of Saturday, the government had 36,000 doses in its stockpiles, the HHS said. The U.S. owns more than 1 million doses that are held by the shot’s maker, Bavarian Nordic, and more than 16 million additional doses can be finished and filled by government request, the agency said. LOBBY WATCH — The Alliance for Regenerative Medicine hosts its congressional fly-in today and Wednesday. Among the group’s asks is reauthorization of prescription drug user fees.
| | | | 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. | | | | | | | | WEDNESDAY: Closing arguments in the Federal Trade Commission’s challenge of Illumina’s acquisition of Grail are scheduled to be heard at 1:30 p.m. EDT.
| | | Amanda Malakoff has joined the Rare Disease Company Coalition as its executive director. She previously was senior director of member relations for the National Association of Manufacturers. Beth Cameron, formally the National Security Council senior director for global health security and biodefense, has been named senior adviser for global health security at the U.S. Agency for International Development.
| | | FDA issued final guidance for medical device manufacturers Monday containing recommendations on what electromagnetic compatibility information should be included in a device submission. FDA’s pharmacy compounding advisory committee will meet Wednesday to discuss four substances nominated to be added to the 503A Bulks List.
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