The FDA's Use of Accelerated Approval Programs in Medicine

Since the outbreak of the 1992 AIDS/HIV epidemic, the Food and Drug Administration (FDA) has relied upon ‘Accelerated Approval’ programs. These programs provide pharmaceutical manufacturers greater leniency when commercializing a potentially life-saving drug and also allows both patients and physicians to take more extraordinary measures to combat a life-threatening illness.

The umbrella term of accelerated approval programs applies to four types: (1) the fast-track designation, (2) the breakthrough designation, (3) the accelerated approval pathway, and (4) the priority-review designation. Each program is used based upon select criteria and requires, in every case, a post-confirmatory trial to determine whether there is a clinical benefit to the drug or not.

Historically, accelerated approval programs were not as commonplace as today. Now, the FDA’s usage of accelerated approval programs is ubiquitous. To elaborate, since 2015, the FDA has granted manufacturers the loosened regulatory benefits in the majority of cases as it relates to oncological fields. While the FDA has advanced the timeline of certain oncological drugs, the program has not always been a success.

Lidocaine was once prescribed to cardiac patients under accelerated approval status. This was because lidocaine showed remarkable promise at quelling heart arrythmias, but in a post-confirmatory trial, the results showed that lidocaine adversely affected heart patients on a magnitude of 3.6 times to 1.0 when compared to the control group.

Even today, professionals are torn regarding the risk-benefit assessment that must be conducted by the FDA and associated sponsors on accelerated approval drugs. For example, critics of accelerated approval programs believe untested drugs pose a risk, financially and physically, to patients. If there is an urgency to push out potentially life-saving drugs, why is there not a similar sense of urgency to protect the patient’s life? Conversely, the proponents state most are volunteers but recognize that, in some ways, physicians may be promising a false hope to some patients.