Report: Few companies post compassionate use policies

Few pharmaceutical and biotech companies post their compassionate use policies on their websites, and almost no companies comply with all of the reporting requirements that are mandated in the 21st Century Cures Act (H.R. 6), according to a report released Tuesday by Avalere Health. H.R 6, which has been passed by the U.S. House of Representatives and is expected to be on the Senate agenda in the lame duck session, would require that companies post compassionate use policies, contact information for submitting requests, procedures for making requests, criteria that will be used to evaluate requests, and the time required to acknowledge receipt of requests. Drug developers would have to comply with the compassionate use provisions within 60 days of enactment of H.R. 6, or when they start the first Phase II or III study of an investigational drug. ...