In the last 20 years, the number of drugs that have been granted Fast Track status by the federal Food and Drug Administration has increased by more thAn five-fold. The program, which began in 1998, granted Fast Track designation to 21 drugs in its first year and 108 drugs in Fiscal Year 2017.
The program was authorized by Congress in 1997 through the Food and Drug Administration Modernization Act. In the words of the statute, the program is designed to expedite development and review of drugs when bringing a drug to market “for the treatment of a serious or life-threatening disease or condition” when the drug company demonstrates the drug’s “potential to address unmet medical needs for such a disease or condition.”
The goal is to get important new drugs and biologics to patients more quickly.
Origin during AIDS crisis
The impetus for the Modernization Act was the AIDS/HIV crisis, during the early stages of which there were no effective treatments. The first accepted Fast Track product was the AIDS drug Efavirenz.
Determination of whether a drug is eligible for the program involves consideration of multiple factors, including the drug’s likely impact on survival, day-to-day functioning, and the degree to which the condition, if left untreated, will progress to a more serious condition.
The FDA provides examples of such conditions: AIDS, cancer, heart failure, Alzheimer’s and severe bacterial and fungal infections. Diabetes, depression, and epilepsy also can be considered serious.
Methods of expediting approval
Drug companies can apply for Fast Track designation at any time during the process of drug development, including at the time of submission of the Investigational New Drug (IND) application. Under the Modernization Act, the FDA is directed to act on a drug company’s request for the designation within 60 calendar days of receipt of the request. In recent years, between 70 and 80 percent of Fast Track applications have been granted.
Once an application has been granted, the drug becomes eligible for different types of special treatment from the FDA. The FDA will meet more frequently with drug companies regarding Fast Track products than products that are not Fast Track designated.
In addition, drug companies can submit completed sections of a New Drug Application (NDA) or Biological License Application (BLA) and obtain prompt review rather than waiting for the entire application to be complete. This process is referred to as a “rolling review.”
The Fast Track program is one of four related processes for expedited review of certain categories of drugs.
Lists of approvals for New Drug Applications and Biologic License Applications are available at fda.gov.
Balancing speed and safety
Although getting new drugs to market promptly is desirable, the process must be balanced with the need for safety. The archetypal case of the need for caution is Thalidomide, which was used to treat nausea and difficulty sleeping in the 1950s and 1960s.
Thalidomide was widely used in Germany, but a drug reviewer for the FDA did not approve its use in the U.S. out of concern that there was not enough evidence about the drug’s safety. Thalidomide caused approximately 10,000 children, mostly in Europe, to have severe congenital deformities (phocomelia).
More recently, in 2012, Ponatinib was granted Fast Track status for treatment of chronic myeloid leukemia (CML). Within one year, the drug was found to cause a high frequency of serious adverse vascular events. Approval of Ponatinib was withdrawn, although it was later reintroduced for a much narrower class of patients for whom there were no alternative treatments.
Jeff Atkinson is a professor for the Illinois Judicial Conference and has taught health care law at DePaul University College of Law in Chicago.
September 1, 2019
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