The Food and Drug Administration is expected to expand access to experimental medications for terminally ill patients later this year, but is resisting an attempt by a patient-advocacy group to make access to unapproved drugs a constitutional right.  Some bioethecists believe the dilemma is  a priority issue between the patient’s need for access to treatments and the government’s responsibility to ensure public safety. 

Last month, the FDA proposed to expand patients’ drug access by making it easier for physicians and other providers such as hospitals to understand when they can obtain unapproved medications. 

In the U.S. Court of Appeals for the District of Columbia, a groundbreaking case is examining whether terminally ill patients have a right of due process to experimental drugs. If successful, the lawsuit would break the long-standing regulation that a drug must undergo three phases of testing before becoming available to the public.

The new rules are intended to give physicians clear directions on when to grant access to medications, even perhaps at the earliest stage of development, in cases in which the FDA deems the potential benefits outweigh the risks.   read more…