FDA Lessens Drug Restriction for Dying Patients

By Rachel Stockton (rachels@foodconsumer.org)

The Food and Drug Administration (FDA) launched a new website today that will assist in getting investigational drugs to patients who have no other options, and who are ineligible for clinical trials. The purpose is to provide information to both patients and health care providers by outlining options they may have available to them by are unaware of.

Since the1970s, the FDA has allowed patients to access some drugs that have not been finally cleared by the FDA, such as some HIV medications.  Over the years, large patient groups consisting of those with cardiovascular disease, cancer, and HIV have been approaching the FDA for greater access to some of these investigational drugs.

There are several reasons why patients look to some of these other drugs for help, such as if the drug they are currently taking either doesn't help, or the patient's side effects are too severe.  For those who are open to other options, the new website helps the patient and his health care provider decide whether or not they want to take part in a clinical trial, which will be used to assess whether the positive aspects of the drug outweigh the negative side effects.

The FDA is now allowed to offer expanded access, sometimes called "compassionate use," to patients who have a serious or immediate life threatening illness without participating in a clinical trial.  The new website was designed to allow the FDA to take such investigational drug requests on a case by case basis.

In order to gain access to some of the drugs, several criteria will have to be met.  One is that the patient must have a life threatening illness for which there are no comparable options.  The drug manufacturer must also "allow" the patient access to the drug and must work with the patient's physician to come up with FDA authorized arrangements.  The constant oversight is necessary to mitigate risk to the patient, the website maintains.