Former FDA Official Howard Sklamberg Comments on FDA Layoffs, Oversight, and State Inspection Plans in The Associated Press, Other Outlets
Howard Sklamberg, Life Sciences & Healthcare Regulatory partner and former top FDA inspection and enforcement official, was quoted in The Associated Press, Bloomberg Law, and SupplySide Supplement Journal regarding significant agency changes.
In The Associated Press article, "FDA Hiring Contractors to Replace Fired Staff Who Supported Safety Inspections," he highlighted inspection challenges amid staff departures, stating, "If you put all this together, even if you didn't have a reduction in the number of people who do the inspections, you're reducing their support," adding that "the natural result is going to be fewer inspections."
In the Bloomberg Law story, "FDA's Drug Office Handling Disputes, Complaints Goes Dark," Sklamberg — former director of compliance at the Center for Drug Evaluation and Research (CDER) — said the division is "very well respected within FDA and with industry," and that if shut down, it "would be a huge loss and would be an impediment to timely and thorough review of drug applications."
In the SupplySide Supplement Journal piece, "FDA plan to delegate food inspections to states sparks concerns over 'Wild West' oversight of supplements," he expressed concerns about states' varying capabilities with dietary supplement inspections, calling the transfer "a very complicated task" and noting that "states do not generally do dietary supplement inspections the way FDA does [to FDA standards]."
Read The Associated Press article.
Read the Bloomberg Law article (subscription required).
