Friday, August 23, 2024

Is the US prepared for tropical diseases?

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
Aug 23, 2024 View in browser
 
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By David Lim and Lauren Gardner

Programming note: Prescription Pulse will be on break next week. We will be back in your inbox on Sept. 4. 

Driving The Day

An Aedes aegypti mosquito sucks blood from a person.

Reported infections in the U.S. of diseases caused by insects like mosquitoes have doubled over the last two decades. | Luis Robayo/AFP via Getty Images

TROPICAL DISEASE BUZZ — As the CDC warns travelers about yet another tropical disease threatening anyone returning from South America or the Caribbean, public health experts are growing concerned about the U.S.’ ability to prepare for and respond to such outbreaks, Lauren writes.

Climate change, urbanization and world travel have increased the odds of those insect-borne diseases taking hold domestically. But the spread of illnesses like dengue and Zika can be difficult to predict and even more complex to handle than respiratory pathogens, according to Cyrus Shahpar, director of pandemic and biological threats intelligence at the White House Office of Pandemic Preparedness and Response Policy.

What the administration is doing: The White House pandemic office counts vector-borne diseases among its core priorities, Shahpar told Lauren.

In February, HHS and the CDC — which started as a malaria prevention agency — released a national strategy to prevent and control vector-borne diseases. The document, which features input from more than a dozen federal agencies, describes goals for the government to meet to improve its readiness for outbreaks while acknowledging gaps in surveillance and testing infrastructure and in available therapeutics.

Anna Durbin, a Johns Hopkins professor who studies experimental vaccines for tropical diseases, said it’s hard to convince drug companies to stick with the regulatory process for getting shots and treatments to market given the variability of outbreaks.

Worries persist: Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, said he wants to see the White House office do more. He’s concerned that the strategy lacks urgency about the threat of vector-borne diseases that could flourish in regions like the Gulf Coast, where he lives.

Harris County, which includes Houston and has its own vector control department, is an exception, Hotez said. He’d like to see the federal government be more bullish on deploying advanced surveillance technologies to ascertain what pathogens are spreading where so governments can plan interventions like spraying.

Latest CDC warning: The agency issued a health advisory on Aug. 16 warning clinicians to monitor returning travelers for Oropouche virus disease, which is endemic to the Amazon basin but has spread. Eleven American travelers have been identified, but authorities are concerned because of the risk of stillbirth or birth defects if pregnant people get infected.

“Zika was terrifying,” Hotez said of the virus, which also causes the birth defect microcephaly, which causes a small head size, in newborns. “Now we’ve got at least two viruses doing that.”

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Lauren successfully eliminated one mosquito from her home while writing this morning’s story.

Reach out and send tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

Eye on the FDA

A woman receives a Covid-19 vaccination.

Updated Covid vaccines will be ready for the upcoming respiratory virus season. | Joe Raedle/Getty Images

COVID SHOTS ON DECK — The FDA signed off Thursday on Moderna’s and Pfizer-BioNTech’s updated Covid vaccine formulations for the 2024-2025 respiratory virus season, Lauren writes.

The agency approved the vaccine for people 12 and older. It also updated the emergency use authorization for children ages 6 months through 11 years to include the new formula.

CDC Director Mandy Cohen formally recommended the updated Covid shots for individuals 6 months and older in June.

Pharmacies and providers are expected to have both options available in the coming days. The FDA has yet to endorse Novavax’s updated Covid shot, but the company said earlier this month it expects to begin offering it at the start of the season.

In the Courts

FDA SUED OVER NCI DECISION — A North Carolina pharmaceutical company, Liquidia, is suing the FDA over the agency’s decision to grant a three-year exclusivity period to United Therapeutics’ Tyvaso DPI, an inhalation powder used to treat high blood pressure in the lungs.

“This decision violates clear congressional intent to allow NCI exclusivity only for true innovations that are supported by new clinical studies that demonstrate safety and/or efficacy of the innovation,” Liquidia CEO Roger Jeffs said in a press release.

Liquidia argues that the action is improper and stifles its efforts to bring a competing drug to market, which is now delayed until the exclusivity expires on May 23, 2025. The lawsuit was filed in the U.S. District Court for the District of Columbia.

“The FDA generally does not comment on possible, pending or ongoing litigation,” the FDA media office said in an email when asked about the lawsuit.

Attempts to reach United Therapeutics for comment were unsuccessful.

Pharma Worldwide

WHO RECOMMENDS NEW TB REGIMENS — The World Health Organization recommended three new treatment regimens for some drug-resistant strains of tuberculosis that rely on a nine-month duration of oral drugs instead of an 18-month regimen.

“It should be remembered that around half a million people fall ill with MDR-TB/RR-TB every year, and many die from it,” said Dr. Lorenzo Guglielmetti, Doctors Without Borders’ director of the endTB project and co-principal investigator of the clinical trial underpinning the new recommendations.

U.K. AGENCY GREEN-LIGHTS ALZHEIMER’S DRUG — Eisai and Biogen announced Thursday their early Alzheimer's disease treatment Leqembi received marketing authorization from Great Britain’s Medicines and Healthcare products Regulatory Agency.

But the U.K. National Institute for Health and Care Excellence said the medicine’s benefits are too small to justify its costs in a draft guidance.

“This is a new and emerging field of medicine which will no doubt develop rapidly,” Dr. Samantha Roberts, chief executive of NICE, said in a statement. “However, the reality is that the benefits this first treatment provides are just too small to justify the significant cost to the NHS.”

WHAT WE'RE READING

Planned Parenthood clinics in Florida are offering IV sedation to patients seeking placement of an intrauterine device as birth control, Joe Mario Pedersen of Central Florida Public Media reports.

GSK CSO Tony Wood talks with Endpoints News’ Andrew Dunn about his company’s pharmaceutical pipeline.

Document Drawer

The FDA issued final guidance containing an electronic submission template for medical device makers submitting products through its de novo pathway for review.

FDA Commissioner Robert Califf met with top Government Accountability Office staff — including Comptroller General Gene Dodaro — earlier this month to discuss “medical products and food safety,” according to newly disclosed public calendar documents.

 

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