The Food and Drug Administration (FDA) has a detailed process for approving medications and medical devices. Sometimes the process is sped up for medications or cures that are the first of their kind or substantially better than currently available medications. Neither all medications nor all medical devices go through the same expedited approval process.
The FDA has four methods of making medications available as quickly as possible. Based upon consideration of various circumstances, a medication will be assigned to the appropriate process.
The Fast Track process is designed for medications that treat serious medical conditions that currently have an unmet medical need. While what is considered a serious medical condition is a matter of judgment, some conditions includes AIDS, Alzheimer’s, heart failure, cancer, epilepsy, depression, and diabetes, among others. The manufacturer must request Fast Track designation, but the request can be initiated at any stage during the FDA approval process.
Breakthrough Therapy is used for any medications that demonstrate via clinical trials that they will provide a substantial improvement over available treatment options. The manufacturer must request breakthrough therapy before the end of the second phase of its clinical trials.
Accelerated Approval allows medications for serious conditions that can fill an unmet medical need to be approved based on a surrogate endpoint, or a marker that can indicate the clinical benefit of a drug. Accelerated approval was created because it can take many years to understand whether a medication successfully treats a condition, and accelerated approval can save valuable time in the approval process. The manufacturer is required to continue to conduct studies to confirm the drug’s benefit. The FDA can withdraw the approval if the studies fail to prove any benefit.
Priority Review designation commits the FDA to take action on the new drug application within six months (rather than the standard 10 months). The FDA reviews each application and designates each one for either priority or standard review, but a manufacturer can also request priority review. Priority review is applied to any drugs that, if approved, would greatly improve the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
While the FDA has formal processes for both expedited and standard new drug applications, many medications and medical devices that obtain approval are later shown to have adverse effects. Medication and medical device manufacturers have a responsibility to test the safety and efficacy of their products and to properly warn patients and doctors of the associated risks.