On August 31, 2018, Michael Blume was quoted in InsideHealthPolicy in an article about a guidance policy issued by the Department of Justice (DOJ) that has provided industry lawyers a potentially new tool to fight the Food and Drug Administration (FDA) enforcement action brought against a company using guidance documents as the basis for enforcement.
According to the article, in November 2017, Attorney General Jeff Sessions issued a policy prohibiting departments from issuing guidance documents that aim to create binding standards by which regulated entities must comply. In January 2018, former Associate Attorney General Rachel Brand also issued a new policy prohibiting DOJ from using civil enforcement authority to adapt agency guidance documents into binding rules.
Commenting on the DOJ guidance policy, Mr. Blume said that companies who are facing enforcement action from FDA or DOJ should use the Brand memo as leverage. There are several arguments a company or a lawyer representing a company can make that may at least give DOJ and FDA pause before they pursue litigation.
Blume also noted, "The first argument ... is simply that whatever contact you as an enforcement attorney are looking at, we complied with the guidance. The Brand memo did not say that guidance means nothing. If industry or if your client or if your company was trying in good faith to comply with the guidance and did comply with the guidance, that is a good argument to tell people to back off. The Brand memo says nothing about that."