HHS Plans OTC User Fee Carve-Out, Lawyer Questions Statutory Authority

HHS late Tuesday evening (Jan. 5) indicated it planned to exempt distilleries and other small businesses that supplied hand sanitizer during the COVID-19 public health emergency from FDA’s over-the-counter monograph user fee program. However, an industry lawyer said there doesn’t appear to be a statutory basis for such a carve-out. If HHS moves forward with its exemption, FDA will have to recalculate its user fee rates and likely will have to hike rates for the rest of the OTC industry,...