The U.S. Department of Justice (DOJ) unveiled two interim final rules intended to deal with enforcement activities in connection with policies enunciated over the past four years, including the so-called Brand memo, which banned federal prosecutors from using federal agency guidance as leverage in prosecutions of private-sector entities. While the terms of the Brand memo had been written into the Justice Manual in December 2018, this new rulemaking effort would seem to eliminate any prospect that life science companies will be prosecuted for mere violations of FDA guidance rather than for violations of the statute.

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