Blog Post
06/05/2017
By Jonathan A. Havens

Recently-confirmed U.S. Food and Drug Administration (FDA or the Agency) Commissioner Dr. Scott Gottlieb indicated in his first remarks to Congress as the Agency’s chief that FDA will be taking steps to lower drug prices. Interestingly, and as Gottlieb admitted in his testimony before a House Appropriations subcommittee, the Agency does not have a direct role in drug pricing. Gottlieb also noted in his statement that that the Trump administration’s federal hiring freeze at FDA is officially over.

Blog Post
03/08/2017
By Jonathan A. Havens

The American Health Care Act (AHCA), released by House Republicans late on March 6, 2017, would repeal and replace certain portions of the Affordable Care Act (ACA). The legislation does not address section 4205 of the ACA, from which the U.S. Food and Drug Administration’s (FDA or the Agency) Menu Labeling Rule emanates. This means that covered establishments should expect FDA to move forward with enforcement of the Rule starting on May 5, 2017.