Trump Signs Stimulus Measure That Prevents Drug Shortages and Revamps OTC Rules
President Trump signed a stimulus measure Friday that would help prevent drug shortages and change how the FDA deals with over-the-counter drugs.
The emergency law requires the FDA to prioritize and expedite reviews of drug applications and inspections to help mitigate or prevent drug shortages. It also requires drugmakers to report when active pharmaceutical ingredients or devices associated with drugs cause supply disruptions and to have contingency plans to ensure back-up supplies and provide details about production volumes.
The new law allows the FDA to approve changes to OTC drugs administratively as opposed to going through a full notice and comment rulemaking. It also allows manufacturers to seek an 18-month market exclusivity for products deemed “innovative.”
The legislation gives the FDA new authority to collect user fees for OTC drugs, due at the time a request is submitted. Beginning in fiscal 2021, the agency may charge $500,000 for labeling changes, and $100,000 for requests unrelated to labeling.
The House passed the measure in a voice vote Friday and the president signed it within hours. The Senate passed the bill two days earlier by a vote of 96-0.
Read the full text of the bill here: www.fdanews.com/03-27-20-BILLS-116hr748eas.pdf. — Jordan Williams