WASHINGTON — Drug companies are routinely flouting a law requiring that they publicly disclose detailed policies on how they handle patient requests to provide access to experimental drugs outside clinical trials, according to a STAT review.
A provision in the 21st Century Cures Act said drug makers must disclose their policies on so-called expanded access requests, which are generally made by terminally ill patients. The language doesn’t force companies to offer the experimental treatments, but it does aim to help patients navigate the system more easily — making readily available information including whether companies accepts the requests, who a patient can contact in such cases, and how long it typically takes the drug maker to respond.
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