In December 2006, the FDA proposed revisions to its expanded access programs.  At that time, FDA Commissioner Andrew von Eschenbach said, "This proposed reform is carefully designed to balance several objectives.  One Goal is to enable many more patients who lack satisfactory alternatives to have access to unapproved medicines, while balancing the need for safeguarding the individual patient.  Another equally important goal is to ensure that continued integrity of the scientific process that brings safe and effective drugs to the market."

Since the proposed rules were published in December 2006 and the comment period closed in March 2007, NPAF would like to express its concern about the failure of the FDA to issue final rules relating to expanded access programs and to limits on charging for investigational drugs.  NPAF along with the Cancer Leadership Council strongly supports and eagerly anticipates the prompt issuance of these rules in final form.  Patients seek more treatment options, which should be facilitated by the adoption of the expanded access program outlined in the proposed rule.  Moreover, the rule on charging for investigational drugs will enhance patient opportunities to access those new products and to participate in clinical trials.