The Fast Track legislation officially known as the Food and Drug Administration Modernization Act (FDAMA), may have worked better than skeptics have claimed according to Kalorama Information in its report World Pharmaceutical and Biopharmaceutical Market, 2010-2015 (Pipeline Analysis of the Top 50 Companies).
The legislation expedited development and approval for treatments of serious or life-threatening diseases were recognized and consolidated under the administrative umbrella of fast track product designation. Despite some early skepticism by the pharmaceutical industry, and even the FDA, that the benefits of designation were not readily apparent since the individual programs are generally available without designation, according to Kalorama Information, there are indications that fast track designation will be the improvement Congress intended.
Unlike the individual expedited development and approval programs, which affect only part of the drug development timeline, fast track designation has the potential to facilitate the entire process. Industry requests for fast track designation have dwarfed pre-FDAMA industry participation. Yet, the best predictor of the future success or failure of fast track designation is how well it is working now. One of the primary goals of the fast track provision of FDAMA was to expand the scope of expedited review and approval programs beyond treatments for AIDS and cancer to any treatment for serious and life-threatening diseases. Before FDAMA, two-thirds of the fast-tracked products were treatments for AIDS/HIV and cancer, and only one-third were for all other diseases. A review of the indications from the products in a survey sampling frame demonstrated a trend in the direction hoped for by Congress. Half of the indications were for AIDS/HIV and cancer, while the other half were for a variety of other diseases and conditions such as systemic lupus erythematosus, bypass surgery complications, hemolytic-uremic syndrome, sickle-cell anemia, Crohn's disease, amyotrophic lateral sclerosis, rheumatoid arthritis, and pneumococcal lung disease.
Another goal of the legislation creating the new fast track designation was to build upon, and presumably improve, the existing FDA fast track programs. One way that this could occur would be through participation of sponsors early in the development process. Survey results showed a positive trend in that direction because close to half of survey respondents had requested designation during Phase II or earlier. This also thwarted some of the early criticism of fast track as benefiting only the late stages of development.
However, there are some statistics that are not favorable for granting fast tract status to drugs. Out of a total of ten drugs which were withdrawn from the market from 1997 to 2000, seven had been approved on a fast-track basis. In the majority of these seven cases, it is at least questionable whether they were intended for life-threatening or serious disorders.
Improving the program, of course, does not mean putting up additional roadblocks on the path to development and approval. Congress was mindful of this when it set a low threshold for eligibility with permissive criteria language such as "intended to treat" and "potential to address." The FDA has conducted the program so far according to the spirit of the law. The FDA requires that fast track designation requests contain a plausible demonstration of the products' potential and emphasizes that requests should not be voluminous. More than half of survey respondents were able to prepare their requests in less than the time initially estimated by the FDA. The FDA has also been able to approve three-quarters of respondents' designation requests within two months.
More of Kalorama’s findings are contained in the report, which can be purchased at http://www.kaloramainformation.com/
