Regulatory Shortcuts to
The FDA’s fast-track program is saving tens of thousands of lives by helping to
“develop and expedite approval of drugs and biologics that address unmet medical needs for
serious or life-threatening conditions,” according to the Tufts Center for the Study of
Drug Development. Initially focused on products for treating HIV/AIDS and cancer, the fast track
program now targets a growing number of diseases, including Parkinson’s, and “has on average
shaved two to two and a half years off the time usually required to develop a new drug and win
Within the program’s first five years, some 200 drugs received fast track
designations and two dozen of these were approved for marketing to consumers. “Fast track
designations for products aimed at treating diseases other than cancer and HIV/AIDS grew from more than 30
in 2001 to
more than 50 in 2003.”
“The fast track program has had a significant public health impact by speeding
access to new drugs… that afflict millions of patients and result in the loss of tens of
thousands of lives every year in the U.S.,” said Tufts Center Associate Director Christopher-Paul
Smaller emerging companies see the FDA’s fast track designation and accelerated
approval process as a way of hastening a drug s time to market, and sometimes of
legitimizing their science. Consideration under the accelerated approval program can even land a
biotech a development partner and better terms.
Fast track designation differs from “expanded access,” which allows patients
with serious and
life-threatening conditions to access investigational new drugs (INDs) prior to
Sponsors can request, fast-track designation at any time in the drug development
approved, benefits include:
More frequent meetings with the FDA to understand exactly what the agency
wants and quickly address any problems that arise throughout the process.
Option to submit a New Drug Application in sections rather than all at once.
Approval for a study evaluation based on a substitute measurement for the
usual clinical end point of prolongation of survival.
Fast-track designation may or may not lead to a Priority Review, which decreases
by four months the time the FDA targets for reviewing a marketing claim and approving
the completed application. It can, but does not necessarily guarantee accelerated approval.
The FDA also may grant accelerated approval to speed patient access to promising
drugs for serious life-threatening diseases that provide meaningful therapeutic benefit
over existing therapies. Based on preliminary evidence, approval is provisional, with the
sponsor required to conduct post-marketing studies to gather complete efficacy information,
verifying and describing the clinical benefit of the particular drug. Drug companies do not
always make good on their promise to complete these “catch up” trials. If the studies are not
completed with due diligence, or if they fail to verify clinical benefit, the FDA can withdraw
marketing approval or modify labeling claims. Lawmakers have proposed legislation that
would fine companies that fail to perform post-marketing studies within a designated time
frame following approval.
Post-marketing studies are essential in assessing optimal use of drugs and
biologics. Additional information, while not essential for approval, is important in
improving the prescribing and use of the product; product quality; or consistency in product
manufacturing. Post-marketing studies may confirm existing data, raise or answer questions, or
provide new data.
Previously approved drugs (e.g. Paxil, Vioxx, Bextra) may be withdrawn from
they prove to be riskier, have dangerous side effects, or are found to be less
effective than originally thought. Some drugs (Amgen’s GDNF) are withdrawn during clinical
trials because of the drug company’s perceived unacceptable risk to trial participants, while
others (Tysabri for MS) were not withdrawn until they’d already been approved and in use.
 Guidance for Industry Fast Track Drug
Development Programs — Designation, Development, and Application Review;
FDA July 2004
FDA’s Fast Track Initiative Cut Total Drug Development Time by Three Years,
According to Tufts Center for the Center of Drug Development; Press release
 East Bay Business Times March 11, 2005,
Fast track Speeds Drugs to
Market; Susan L. Thomas
FDA Center for Drug Evaluation and Research,
FDA, Oncology Tools
 FDA Center for Biologics Evaluation and Research Report to Congress
Reports on Postmarketing Studies