FDA Set to Expand Access to Unapproved Drugs

In 2007, the FDA appears poised to grant greater access to experimental, unapproved medications by the terminally ill, but whether or not this development will ultimately benefit society is a matter for debate.

In a May 2006, 2-1 ruling on the case Abigail Alliance v. von Eschenbach (Abigail Alliance, a non-profit, sued the FDA; their mission is to help cancer patients get their insurance companies to buy any experimental drug that has passed safety testing), the U.S. Court of Appeals for the District of Columbia ruled that patients had a right to access investigational medicines. Since then, the FDA created a proposal to expand access to unapproved drugs and invited the public to comment on those rules.

When the FDA issues its new guidelines, it is expected that education and outreach efforts will provide patients all the information they and their physicians need to process their applications. However, critics worry that experimental drugs will only provide false hope and may end up causing more suffering and harm.

Critics point out that these post-phase I drugs have been tested for safety on only a relative handful (few tens) of people and may not have shown any safety side effects. The new FDA rules might derail the current controlled safety and testing protocols by providing more widespread access to investigational drugs. "Why should people enroll in a randomized, controlled study--where they could be put in the group receiving only conventional treatment--when they could just get their insurance to pay for whatever drug they thought was best?" asks Ezekiel J. Emanuel in The New Republic.

in his article, Mr. Emanuel points out that the FDA has allowed access to investigational medicines, introducing (in 1987) a Treatment Investigational New Drug (IND) program. "The FDA gives Treatment INDs on the condition that the drug has shown some evidence of being effective (not just safe, as the Abigail Alliance would have it) and that giving it to the patient won't inhibit the collection of research data," he writes. "But the advantage is that the administration of the drug is carefully monitored for safety."

Will the FDA's new rules put patients on the road to recovery, or merely speed the terminally ill on their way? For certain, the debate on this issue has only just begun.

Article References
FDA Primed to Help Dying Patients Gain Easier Access to Unapproved Drug, PharmaLive site accessed on 01/30/2007.

Drug Addiction, The New Republic, site accessed on 1/30/07.