Former FDA Official Howard Sklamberg Talks With Pink Sheet on FDA's Expansion of Foreign Inspections and Leadership Transition

Howard Sklamberg, Life Sciences & Healthcare Regulatory partner and former FDA Deputy Commissioner for Global Regulatory Operations and Policy, was quoted in the Pink Sheet article, "US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers." The story examines the agency's plans to expand unannounced inspections of foreign drug manufacturing facilities with a pilot program underway in India and China, along with the retirement of longtime inspections leader Michael Rogers.

Sklamberg pointed out that the impact of surprise inspections abroad is often overstated, describing the perception that investigators will uncover critical compliance issues simply by arriving unannounced as the "movie version of an inspection." He explained that this dramatic expectation rarely matches reality because "when foreign facility inspections are not announced, the surprise only lasts the first day," which inspectors typically spend gathering documents.

On Rogers' departure, Sklamberg said he was "incredibly trusted and well liked among inspectors at FDA" and called his retirement "a very big loss for FDA and the public."

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