Sklamberg Discusses FDA’s Request for Comment on Improving Agency Guidance

Howard Sklamberg, Life Sciences & Healthcare Regulatory partner and former FDA Deputy Commissioner, was quoted in the Law360 article, “FDA Seeks Comment On Ideas To Improve Agency Guidance.” The article discusses the U.S. Food and Drug Administration’s recent notice to request comment from pharmaceutical companies, healthcare providers and others on the agency’s strategies to improve how it develops and communicates nonbinding guidance.

Sklamberg told Law360 that the FDA aims to gather public input without delaying the issuance of guidance. “There's been some frustration by some in industry, by some in Congress, by other observers that some FDA guidances will remain in draft form for many, many years,” he said. “There have been calls for FDA to streamline its process and to have its process be more transparent.”

The FDA outlined its ideas in a draft report on best practices for issuing guidance. Sklamberg noted that lawyers may want to ask their clients if they would like to provide their input on the FDA’s proposals. “The fact that the agency understands the need to improve its processes regarding things like input and transparency means it is going to generally be open to getting input, even under its existing policies,” he said.

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