Following on the heels of more than 40 state legislatures, the U.S. Congress passed a federal right-to-try law giving patients access to unapproved drugs outside of the standard clinical trial and Expanded Access system. Unfortunately, the new federal law only creates more questions, which this article explores.
With one notable exception, the federal government has not enacted any major new regulatory schemes targeting pre-approval access of investigational products outside of clinical trials. That exception, the federal Right-To-Try law represents the culmination of three years and forty individual state initiatives. Similar to previous efforts such as reimportation, it represents an attempt by the legislature to fix what some people opine as an overly cautious and conservative U.S. Food and Drug Administration (“FDA”). Unfortunately, as with other “legislative fixes,” the law does not preempt competing state laws leaving industry to cope with over 40 different requirements.
To read the full article, visit Life Science Compliance Update.