FDA outlines path to obtain reference drugs under REMS

FDA released draft guidance designed to help generics companies obtain reference drugs for bioequivalence (BE) studies when those drugs are subject to REMS and are not available through regular distribution channels.

The agency said companies submitting an ANDA may ask FDA to send a letter to a reference drug's sponsor stating that a proposed BE study will be conducted under protocols comparable to those in the reference drug's REMS and elements to assure safe use (ETASU). The letter also would say the agency will not consider it a violation of the REMS if the reference drug sponsor sells a sufficient quantity of the drug for the BE study. ...