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Tracy Beth Høeg, Makary Aide Who Investigated Covid Vaccines, to Lead FDA Drug Center
Tracy Beth Høeg, a top lieutenant to the U.S. Food and Drug Administration (FDA) Commissioner Marty Makary, will be the next leader of the Center for Drug Evaluation and Research (CDER), according to an announcement from the FDA.
“CDER plays a crucial role in ensuring the medicines we rely on are both safe and effective,” Høeg said in a statement. “This is an incredible opportunity to serve my fellow Americans.”
Høeg’s appointment as the agency’s top drug regulator comes after CDER Director Richard Pazdur filed paperwork to retire at the end of the month. Pazdur accepted the role less than a month ago at the urging of Makary. Høeg will be the fifth person to lead the center this year.
HHS responds to Governor Pritzker’s vaccine legislation
The U.S. Department of Health and Human Services (HHS) responded to recent legislative moves in Illinois. Governor JB Pritzker signed HB 767. This empowers the Illinois Department of Public Health to offer vaccine guidelines through its own Immunization Advisory Committee (IAC), while also expanding vaccine access.
However, HHS Communications Director Andrew Nixon responded to Illinois officials with, “Democrat-led states that imposed unscientific school closures, toddler mask mandates and vaccine passports during the COVID era are the ones who destroyed public trust in public health and should not be guiding policy.
“Now, the same governor who eroded public trust is trying to reinvent public health under the guise of ‘filling a void.’ The Trump Administration and Secretary Kennedy are rebuilding that trust by grounding every policy in rigorous evidence and Gold Standard Science – not the failed politics of the pandemic.”
12 Former FDA Chiefs Blast Prasad’s Move to Toughen Vaccine Standards
A dozen former U.S. Food and Drug Administration (FDA) commissioners are condemning a move by the agency’s current top vaccine official, Vinay Prasad, to propose radical changes to the way it reviews new immunizations.
The commissioners, whose tenures date back to the administration of former President George H.W. Bush, argued in an article published in the New England Journal of Medicine that Prasad’s planned policies are based on a “reinterpretation of selective evidence” that “breaks sharply with the norms that have anchored the FDA’s globally respected scientific integrity.” Those new rules, if enacted, “undermine a regulatory model designed to ensure that vaccines are safe, effective, and available when the public needs them most,” they wrote.
Prasad’s contemplated framework, outlined in a memo sent to agency staff last week, proposes mandating that all vaccine applications conduct large, randomized and controlled trials for new shots — even when updating older versions of well-studied shots for influenza and COVID-19.
That protocol would break from longstanding standards that enable speedy clearance of these updated shots based on their ability to spur an immune response, a critical tool in keeping up with evolving viral threats.
FDA to Lower Number of Trials Required for Approval of Drugs, Other Medical Products
The U.S. Food and Drug Administration (FDA) plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration for approval, FDA Commissioner Marty Makary told STAT on Wednesday.
While historically the FDA has required two trials for added assurance of a drug’s safety and efficacy, it has become increasingly flexible and many drugmakers already submit just one pivotal clinical trial for approval. Makary said that while the agency will still require two in some cases, the default will be one trial.
“You can achieve the same statistical power with one trial as you would with two trials when it’s designed and controlled appropriately,” Makary told STAT by phone.
EPA Rollback of Air Pollution Standards Threatens Adirondacks
The U.S Environmental Protection Agency (EPA) rolled back regulations on air polluters twice in the past week by exempting steel plants from rules governing coal-fired smokestacks and by asking a federal court to drop the 2024 improvements to the National Ambient Air Quality Standards for fine particles of soot.
“Coal fired power plants nearly destroyed the Adirondack Park’s forests, lakes and ponds with acid rain,” said Adirondack Council Clean Air Specialist and Director of Communications John F. Sheehan. “Things are starting to get better here after 30 years of pollution reductions. We don’t want to undo this win and once again lose trees and fish.”
“The 2024 soot standards were 25% better at protecting public health than the old standard, which now goes back into effect,” Sheehan said. “Rolling back National Ambient Air Quality Standards undermines public health and safety and will have lasting economic impacts for the country. The nation saves $20 in public health costs for every dollar spent cutting air pollution such as soot, ozone and sulfur dioxide.”
