Ed Silverman , 2025-05-06 13:04:00
Top of the morning to you. Gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us. Remember, a prescription is not required. Our choice today is blueberry cobbler. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch. As always, feedback, criticism, and suggestions are welcome. …
Amid ongoing anticipation over tariffs on pharmaceuticals, President Trump signed an executive order designed to lower regulatory hurdles and make it faster for drug companies to manufacture their products in the U.S., STAT writes. The move also includes plans to place more pressure on foreign drugmakers to comply with quality control inspections. At the top of the list is a mandate for the U.S. Food and Drug Administration to reduce the amount of time to approve domestic pharmaceutical manufacturing plants. The agency is being directed to eliminate “duplicative and unnecessary requirements,” streamline reviews, and work with “domestic manufacturers to provide support before facilities start functioning.” Goals were not mentioned in the order. At the same time, the Environmental Protection Agency was ordered to accelerate approval of construction of facilities for manufacturing medicines, active pharmaceutical ingredients, and related raw materials.
Meanwhile, a key FDA official who oversaw inspections disclosed that he will retire on May 14, CBS News notes. Michael Rogers, the Associate Commissioner for Inspections and Investigations, announced his plans in an email to FDA employees on Monday. His office has a staff of about 3,600 people located throughout the nation in about 227 locations. Two FDA officials said Rogers had told colleagues privately that he was miserable in recent days, as the agency inspections office has reeled from sweeping cuts to its ranks ordered by U.S. Health and Human Services Secretary Robert F. Kennedy Jr. The cuts have come as FDA Commissioner Marty Makary has publicly touted plans to expand foreign surprise inspections, despite the agency privately struggling to keep up with inspections due to layoffs, early retirements, and resignations.
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