FDA to streamline approval process
pharmafile | October 24, 2003 | News story | |
The FDA has launched a programme to speed up approval of new drugs in response to growing concerns about lengthening review times and the scarcity of new drug launches.
Chief Commissioner Dr Mark McClellan has stressed that there is no evidence that the time taken for top priority drugs to be approved has lengthened, and said the focus would be on improving quality rather than shortening review times.
"[The review] will focus on improving quality of submissions to the agency while streamlining the time to obtain the information, thought additional guidance, interactions, and clarifications of confusing areas such as combination products or pharmacogenomic tests", he said.
The Agency says companies often fail to provide data to support the claims they wish to make on the product label, or do not submit convincing evidence of adequate manufacturing facilities to produce the drug.
One recent example of this is Clarinex, Schering-Plough follow-up to its number one allergy treatment Claritin, severely delayed because of long-standing problems at its US manufacturing sites.
The FDA has pledged to identify all possible root causes for "multiple review cycles" and says early communication and other steps to improve quality of submissions were vital.
ImClone's cancer drug Erbitux was one case causing greatest concern last year, with the FDA's rejection of the drug coming as a surprise to investors. FDA employees have been implicated in an on-going investigation into fraud and insider trading at the biotech company.
Wider concerns about the overall drop in the number of innovative new drugs reaching the market have also influenced the review, with just 17 new chemical entities approved by the FDA in 2002, compared to 24 in 2001 and the record 53 in 1996.
Dr McClellan has echoed the remarks of Thomas Lonngren, the head of Europe's drug regulator EMEA, in blaming a falling number of submissions for the fewer number of launches experienced on both sides of the Atlantic.
The regulators agree there are a number of complex reasons behind the sluggish pipelines, citing an early 1990s dip in R&D investment now beginning to bite, as well as industry mergers and the new challenge of genomics and proteomics as leading factors.
The FDA says it will begin its review in those disease areas it believes to be most in need of improved therapies cancer, diabetes and obesity and will work with external experts and stakeholder groups to develop its strategy.
The news coincided with the US Government's budget for the Agency. One of the many new measures announced is a $13 million initiative to accelerate review of generic drug applications. This follows the launch of a Government programme to increase the use of generic drugs and clampdown on patent law abuses by the pharmaceutical industry.
