The ‘new normal’ for Covid — and tropical diseases

Jun 25, 2024

Presented by Pharmaceutical Care Management Association

Driving The Day

A nurse puts a syringe into a tray.

CDC advisers will vote on vaccine recommendations this week. | Thomas Lohnes/AFP via Getty Images

THREE THINGS TO WATCH AT ACIP — The CDC’s Advisory Committee on Immunization Practices meets this week for its annual June confab as members settle into a meeting cadence that resembles pre-Covid times.

Here are the three discussions we’re monitoring as the committee gathers Wednesday through Friday:

Covid-19 vaccines for the fall: The FDA’s vaccine advisers unanimously recommended earlier this month that manufacturers formulate their shots for the 2024-2025 respiratory virus season based on the JN.1 strain. The agency initially concurred — but then asked vaccine makers a week later to use the KP.2 variant, a descendent of JN.1, “if feasible.”

Paul Offit, a Children’s Hospital of Philadelphia vaccine expert and an FDA panel member, said he worries that approach could dampen the view of Novavax’s Covid shot, which takes longer to make than messenger RNA options and is already planned to incorporate the JN.1 strain.

“I just worry that there would be a sense that Novavax is an inferior vaccine when it’s not,” he told Prescription Pulse.

At a recent Covid-19 Vaccine Education and Equity Project webinar, top FDA vaccine regulator Peter Marks said Covid-19 descendants “will probably be closer” to KP.2 than JN.1.

“From a clinical perspective, there’s only a small amount of data that suggests that, but on first principles, it seems like a good idea,” Marks said. “The best vaccine is the one in your arm,” he added.

Chikungunya vaccine update: Advisers are scheduled to discuss chikungunya and dengue vaccines on Wednesday afternoon, including chikungunya’s epidemiology in the U.S. and the “cost-effectiveness of use of live attenuated chikungunya vaccine among adults living in U.S. territories.”

The confluence of climate change, urbanization and poverty is causing mosquito-borne diseases to take off in the Gulf Coast, said Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. He’s watching out for those two diseases, as well as Zika, yellow fever and parasitic and flea-borne illnesses like Chagas disease and typhus.

“These illnesses are going to become a new normal — if not now, then in the future,” he said.

New groups and updates: We’re watching out for updates on avian flu and respiratory syncytial virus shot uptake in pregnant women and babies.

Another agenda item that caught our attention: the debut of an HPV vaccines working group. HHS has set a goal of increasing the proportion of teens who receive recommended doses of the shot, shown to protect against cervical and other cancers, to 80 percent by 2030.

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. We’re doing our best to dodge the summer colds descending upon D.C. — how about you?

Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

A message from Pharmaceutical Care Management Association:

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In Congress

Cathy McMorris Rodgers departs the U.S. Capitol.

Several GOP members of the House E&C Committee, including its chair, Cathy McMorris Rodgers, are scrutinizing how the FDA conducts foreign inspections. | Francis Chung/POLITICO

GOP PRESSES FDA ON FOREIGN INSPECTIONS — An investigation by top House Energy and Commerce lawmakers into how the FDA conducted foreign inspections over the past decade found “tremendous variation in inspection outcomes” by inspectors with 10 or more inspections in China and India.

The inquiry comes as the FDA attempts to boost the number of foreign inspections after they cratered to near-zero during the Covid-19 pandemic. Persistent drug shortages have drawn scrutiny of drugmaker supply chains, which rely heavily on India and China.

“The Committee is seriously evaluating the disturbing possibility that some of the variation in inspection outcomes could be the result of bribery or fraud,” E&C Chair Cathy McMorris Rodgers (R-Wash.), Investigations Subcommittee Chair Morgan Griffith (R-Va.) and Health Chair Brett Guthrie (R-Ky.) wrote to FDA Commissioner Robert Califf.

However, when referencing reports of foreign manufacturers attempting to “bribe or improperly influence inspectors” the lawmakers initially cited a Philippines FDA report, not a U.S. FDA report. The committee late Monday resent the letter to the FDA with a corrected citation.

FDA spokesperson Amanda Hils said the agency will respond to the committee. "We understand the importance of our foreign inspection program for the health and safety of the American public and the FDA has been responsive to the Committee’s inquiries on this issue," Hils said in an email. "We will continue to engage on any specific questions they have on this or related topics."

The GOP lawmakers said that interviews with FDA officials and employees “may be necessary” and requested responses from the FDA by July 8.

“In the event that the FDA fails to begin production of the requested documents by the deadline specified above, the Committee will consider utilizing compulsory process given the importance of protecting the health and safety of the American people,” Rodgers, Guthrie and Griffith wrote, hinting subpoenas are on the table.

An E&C Committee Democrat spokesperson said Democratic lawmakers weren't looped in until after the letter was sent to the FDA.

SANDERS SETS NOVO HEARING DATE — Mark your calendars for Sept. 24 — that’s when Novo Nordisk CEO Lars Jørgensen is expected to testify before the Senate HELP Committee on the prices of its GLP-1 drugs Ozempic and Wegovy, Chair Bernie Sanders said Monday.

That’s a departure from the original deal Sanders announced on June 14, when the committee said the hearing on the weight-loss and diabetes drugs would be held in “early September.” Novo had offered to send Jørgensen to the Hill on Sept. 25 or 26, the last two days the chamber is scheduled to be in session before the November election.

“We remain committed to discussing solutions that ensure access and affordability for all patients within the complex U.S. healthcare system,” a Novo spokesperson said in a statement.

The development comes after Sanders threatened to subpoena the company’s top North American executive, a fight that spilled out into public view as POLITICO obtained letters in which Novo Nordisk called the chair’s statements about its cooperation with the committee “simply untrue.”

A message from Pharmaceutical Care Management Association:

Industry Intel

TEVA DEBUTS GENERIC GLP-1 — Teva Pharmaceuticals launched a generic GLP-1 injection Monday, an alternative to Novo’s Victoza. The drug’s base peptide is liraglutide, which has been shown to be less effective at inducing weight loss than semaglutide, the building block ingredient for the company’s Ozempic and Wegovy brands.

Still, a generic option for one GLP-1 could help ease the cost burden for patients as well as access issues, since Victoza is on the FDA’s shortage list. But that will also depend on whether pharmacy benefit managers continue to prefer branded alternatives, said Erin Fox, a pharmacy expert at the University of Utah who monitors drug shortages.

And it’s unclear whether generic liraglutide’s availability will help people trying to get Ozempic or Wegovy, Fox said.

Future capacity boost: Speaking of Novo, the company said Monday it will invest $4.1 billion to build a second fill-finish plant in Clayton, North Carolina, focused on injectable drugs for obesity “and other serious chronic diseases.”

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Eye on the FDA

DUCHENNE DRUG DECISION IN FOCUS — Doctors for America’s FDA task force on Monday blasted the agency’s decision last week to expand the label for Sarepta’s Elevidys gene therapy for Duchenne muscular dystrophy, arguing it undermines the regulator’s credibility.

The organization of doctors advocates for affordable health care for Americans and takes issue with treatments being made available to consumers at high price points if the safety or efficacy is questionable.

The group took issue with Marks’ memo detailing his “different conclusion” from agency reviewers about the drug’s efficacy based on a confirmatory trial required for its earlier accelerated approval. The product failed the primary clinical endpoint of that study.

“These instances of approvals based on subjective notions rather than scientific evidence demonstrate the need for an external evaluation of the FDA’s procedures and regulations, and consideration of potential reforms to agency policies,” the group said in a statement. “The public should have confidence that no single FDA official has the ability to overrule multiple expert review teams and top lieutenants to unilaterally approve a drug.”

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WHAT WE'RE READING

The FDA authorized the first menthol-flavored vapes Friday in a bid to help adult smokers transition to less-dangerous tobacco alternatives, David reports, roiling public health advocates who say the products will appeal to children.

Document Drawer

The FDA updated its list on Friday of off-patent, off-exclusivity prescription and over-the-counter drugs without approved generics.

The FDA published final guidance containing compliance advice for small labs pertaining to the agency’s recent laboratory-developed test final rule.

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In an environment of escalating drug prices set solely by drug companies, the pharmaceutical industry is spending hundreds of millions of dollars to advance self-serving policies undermining PBMs and employee pharmacy benefits. It’s time for policymakers to understand these policies will boost the profits of drug companies, and directly target the ability of America’s employers to offer affordable health care coverage.

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