Howard Sklamberg Speaks with the Pink Sheet on Pharmaceutical Company Compliance Issues

Howard Sklamberg, a partner in Akin Gump’s health practice, was interviewed by The Pink Sheet for the article “Ex-US FDA Official Sklamberg On Park Doctrine Limits, Data Integrity.” Sklamberg, a former deputy commissioner for global regulatory operations and policy at the Food and Drug Administration (FDA), discussed several issues, including criminal prosecutions for violations of the Federal Food, Drug, and Cosmetic Act (FDCA) under the Park Doctrine, data integrity, and the mutual recognition agreement on manufacturing inspectional findings between the United States and European Union.

Addressing the need for faster, yet more rigorous, assessments of new drug applications, Sklamberg said he has not seen any change in the FDA’s evaluation process and believes it is paying “at least as much attention to detail as it had in the past.” Additional staffing as well as some internal efficiencies, he said, would lead to an increased pace. Additionally, he thinks “the mutual recognition agreement with Europe is going to free up resources that had been used in European inspections and redeployed.”

With regard to the Park Doctrine, which allows the government to seek a misdemeanor conviction against a corporate officer for alleged violations of the FDCA even if the officer was neither involved in nor even aware of the statutory violation, Sklamberg said he expects the FDA and Justice Department to continue to use it “in appropriate circumstances.” At the same time, however, he thinks the courts “will increasingly find that there are limits on how far it can be pushed.”

Sklamberg said last year’s mutual recognition agreement between the United States and European Union could lead to fewer duplicate inspections. Overall though, he pointed out that the agreement “preserves the right of the E.U. and the U.S. to make different enforcement decisions based on even the same set of facts.”

Finally, Sklamberg addressed the topic of data integrity, which he described as one “that should concern drug manufacturers around the world,” rather than just in India. With that in mind, he noted that the FDA has taken enforcement action globally and will likely continue to do so.

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