FDA to let dying have experimental drugs

In 2007, terminally ill patients in the USA are expected to gain expanded access to unapproved medications. As soon as its proposed guidelines become final later this year, the Food and Drug Administration will proactively assist physicians in getting experimental drugs into the hands of their dying patients, the Food and Drug Law Institute says it has learned.

The FDA is taking action on the controversial issue of access to unapproved drugs as the landmark case of Abigail Alliance versus the agency's Commissioner Andrew von Eschenbach heads toward a possible showdown in the US Supreme Court (Marketletter January 1 & 8), notes the article published in the FDLI Insighter column on the Institute's web site (www.fdli.org). On March 1, the US Court of Appeals for the District of Columbia will hear the FDA's rehearing petition on its May 2006 ruling that terminally ill patients have a constitutionally-based right to have access to experimental drugs that are not fully approved by the agency.

Six months after the ruling by the three-judge appeals court panel, The FDA published a proposal for "significant regulatory changes" to expand access to unapproved drugs.