The Nation’s Top Ddrug Regulator, DR. Richard Pazdur, has decided to Retire Three Weeks after taking the Job. Pazdur privately mused last month, about Retiring from the Food and Drug Administration (FDA) or Returning to His Old Job at the Agency, as He raised Concerns about the Legality and Pace of Agency Plans to Expedite Drug Decisions.
Pazdur’s Retirement follows Tensions with FDA Commissioner Marty Makary, who has touted Mmultiple Initiatives aimed at Bboosting the Egency’s Efficiency. Pazdur had Questioned Makary’s Plans to Significantly Shorten Review times for Drugs Developed by Companies that are Aligned with theCcountry’s Priorities, such as efforts to address Unmet Medical Veeds or Boost Domestic Manufacturing.
Pazdur had spent more than 25 years at FDA, including as the Leader of the Agency’s Oncology Center of Excellence. “This is a very sad day for science and for patients,” said Ellen V. Sigal, Chairperson and Founder of Advocacy Group "Friends of Cancer Research". “Rick was our guiding light and this loss is profound.”
Makary on Nov. 11th Announced Pazdur would Lead the Agency’s Center for Drug Evaluation and Research after the Previous Leader, George Tidmarsh, Resigned under Pressure. Tidmarsh faced Internal Scrutiny and a Lawsuit over His Critique of a Treatment made by a Company that Alleged He had a Vendetta against its Board Bhair.
Vinay Prasad, the Aagency’s Top Vaccine Regulator and a Makary Ally, also had been a past Critic of Pazdur. On Friday, Prasad laid out a Stricter Approach for Federal Vaccine Approvals, writing in an Internal FDA email that His Team had concluded Coronavirus Vvaccines had contributed to the Deaths of at least 10 Children. He did Not detail the Evidence, and His Comments raised deep Alarms from some Public Health Experts and former Agency Staff.
Makary and Prasad extolled Pazdur at length in a Nov. 13th Podcast, saying that His Elevation as the FDA’s Top Drug Regulator would bring Stability and Iinnovation to the Agency. “This is where Rick is a genius, right?” Makary said, Praising Pazdur’s Ability to Expedite New Drug Approvals by Sharing Strategic Guidance with Pharmaceutical Companies.
Wall Street Analysts last month, also said that Pazdur’s Selection was a Positive Sign for FDA, which had Experienced Months of Turbulence under Trump (R). Pazdur was probably the “best choice possible for patients and industry,” Chris Meekins, a Managing Director at Raymond James, wrote in an Investor’s Note.
“Bad news bears,” Meekins said on Tuesday, Reacting to Pazdur’s Decision to Retire. He called the News the Inverse of what He wrote in His Investor’s note last month. The Retirement of Pazdur marks the latest Flash Point for an Agency Dealing with Layoffs and Exits of Senior Officials. Last month, Pazdur said in a Statement through a Department of Health and Human Services (HHS) Spokesman that He remains Committed to the Drug Center’s Mission and His Current Position.
An HHS Spokesman previously said the Department “Strongly Disagree” with the Premise that FDA Decisions are Unpredictable. “Regulatory requirements may evolve as new data emerge, but this reflects a rigorous, science-driven review process, not inconsistency,” Rich Danker, an HHS spokesman", wrote in an email last month.
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