Department of Health and Human Services

Patient Network

Bringing Your Voice to Drug and Device Approval and Safety

Speeding Up Drug Approval

The FDA has developed three successful approaches to making drugs available as rapidly as possible: Fast Track, Accelerated Approval, and Priority Review. Each of these approaches is described below.

Fast Track

Fast Track works to get important new drugs to the patient earlier. Drugs designed to treat serious diseases or that fill an unmet medical need qualify for Fast Track.

  • Drugs that treat serious diseases. These drugs impact survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are all examples of serious diseases. Diseases such as epilepsy, depression and diabetes are also considered to be serious diseases.
  • Drugs that fill an unmet medical need. These drugs provide a therapy where none exists or one that may be better than existing therapy.

Fast Track drugs may be eligible for some or all of the following:

  • More contact with FDA to discuss the drug’s development plan and proposed clinical trials, and to make sure the right data is collected to support drug approval.
  • Eligibile for Accelerated Approval.
  • Rolling Review, which means that a drug company can submit sections of its New Drug Application (NDA) as they are completed, rather than waiting until every section of the application is completed before submitting it.
  • Discussions with FDA if the drug Fast Track status is not granted.

Accelerated Approval

Accelerated Approval allows earlier approval of drugs that treat serious diseases or that fill an unmet medical need based on a surrogate endpoint.

A surrogate endpoint is a marker—a laboratory measurement, or physical sign—that is used in clinical trials to help investigators find out whether the drug offers improvement for the patient.

Surrogate markers can save valuable time in the drug approval process. For example, instead of having to wait to learn if a drug actually can help cancer patients to survive longer, the FDA might now approve a drug based on proof that the drug shrinks tumors. Tumor shrinkage is considered reasonably likely to predict a real benefit to the patient. The drug company will still need to conduct studies to confirm that tumor shrinkage actually does predict that patients will live longer. These studies are known as phase 4 confirmatory trials.

Priority Review

Priority Review means that FDA will review a new drug application in about 6 months. (Standard Reviews can take as long as 10 months.) A Priority Review is given to drugs that offer major advances in treatment, or provide a treatment where no good therapy exists. Drugs that fall into the Priority Review may show

  • Proof of increased effectiveness in treatment, prevention, or diagnosis of disease.
  • Elimination or reduction of a drug reaction that limits treatment.
  • An increase in the patient’s willingness or ability to take the drug according to the required schedule and dose.
  • Proof of safety and effectiveness in a new and specific population, such as children.

Priority Review requests are made by the drug company. Within 45 days, FDA decides whether to approve the Priority Review. This “Priority” does not change the clinical trial period, the scientific and medical standard for approval, or the quality of evidence necessary.