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One In, Two Out Executive Order Will Likely Increase Use of Internal FDA Communications

June 16, 2017

President Donald Trump’s executive order on new regulations will likely lead to increased use of internal communications to make drug policy at the FDA, an expert said at an FDAnews conference on drug-device combination products last week.

In January, Trump signed the “one in, two out” order requiring the repeal of two regulations for each new one, but it may be hard to adapt this mandate in the context of the FDA’s work, according to Bradley Merrill Thompson of Epstein Becker & Green.

Much of the agency’s policymaking is done through clarification rather than new regulations, Thompson said, but a broad interpretation of the order may place even clarifying guidance under that umbrella.

If that’s the case, Thompson said, look for the FDA to increasingly rely on internal documents such as Standard Operating Procedures or Manuals of Policies and Procedures.

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