May 10, 2017
Partner Kristi Wolff
was quoted in the Law360
article “5 Top Priorities As Gottlieb Takes Reins At FDA.” The article discusses five key debates that attorneys expect Scott Gottlieb to prioritize at the U.S. Food and Drug Administration.
Gottlieb will have to make key decisions on the agency’s approach to menus and nutrition labels. The FDA delayed calorie disclosures until May 2018, and nutrition label deadlines are approaching in July 2018 and 2019. “I would expect that industry will look to get guidance on where that's going to go relatively quickly because it is a huge undertaking for a lot of companies,” Kristi noted. “If your deadline gets bumped back an additional 12 months or 24 months, that relieves a lot of pressure, and so you'd want to know that sooner rather than later certainly.”
Gottlieb will be responsible for oversight of off-label promotion, which he has advocated for more leeway of. “This has been a concern for industry, dietary supplements and food, for a while now, that they are required to exist within a regulatory structure that they feel doesn't allow them to make truthful statements about their products,” Kristi said. “And if you look at Dr. Gottlieb's statements ... it would seem that he is potentially open to ... new leeway.”
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