The FDA has its problems, but the quagmire involving getting new drugs to market is not as dire as the agency's critics insist, and neither is the agency the plodding, prohibitive monster that they depict.

That was the premise of the keynote address given Monday by David Kessler, dean of the Yale University School of Medicine and former commissioner of the FDA, at the 21st annual JP Morgan H&Q Healthcare Conference in San Francisco.

Kessler, who helmed the FDA from 1990 until 1997, not only defended his tenure, but also pointed out that the agency has continued improvement trends in approval and review times, despite gaps in leadership.

"For years, the FDA was perceived as the bottleneck that stalled the process, primarily due to the extensive amount of time it took to get drugs approved. However, since the inception of the Prescription Drug User Fee Act [PDUFA] in 1993, approvals have been accelerated in key areas," Kessler said.

He cited as examples a decrease in the number of new molecular entities (NMEs) approved in two years or more and an increase in those approved in one year or less.

Kessler said those who blame the FDA for being overly cautious and for the lengthy approval times are looking at surface statistics and would draw truer insight if they examined more precise numbers that broke data down into more meaningful information.

"There is a distinct difference between approval time, which denotes the time between application submission and market approval, and review time, which involves the time it takes the FDA to make decisions on its own clock," he said, while referring to a chart showing that even though approval times had risen in the previous seven years, review times had remained steady.

He said the FDA had met all of its PDUFA goals, including improvement in the number of first-cycle approvals, and overseeing a shift that eventually allowed the U.S. to outrank countries abroad in getting drugs to market first.

Kessler said the median approval time had shown remarkable advancement since the 1980s, when it took 33 months to reach the approval stage, vs. 12 months at his departure, and 15 months currently.

"Two thousand two was not a year of fanfare, but the FDA is on the right track," he said, adding that last year, more drugs were approved on first cycle than in the past seven years.

He offered more reasons for the long approval times and decreases in the number of new drugs annually, saying drugs that are submitted, reviewed and rejected serve to worsen the review time statistics, and that drugs are rarely submitted and approved in the same year.

We are only as good as what comes in the door, and the 14 NMEs filed in 2002 have predominant implications for 2003, just as many of the 17 approvals in 2002 came in during the previous two years," he added.

Kessler proffered his own solutions to some of the dilemmas afflicting the FDA. They included killing two birds with one stone by addressing the 14 percent to 17 percent attrition rate at the agency, which is significantly higher than that of its federal counterparts such as the NIH, by creating a less contentious relationship between the academic, government, pharmaceutical and investment communities.

Kessler pointed out that a recent survey indicated that 80 percent of the FDA's employees were at least thinking of leaving the agency, and referred to the public blame-assigning battles between the aforementioned groups.

Other solutions offered included the establishment of a national biological laboratory, much like the one in the 1950s that was founded to focus on high-energy physics; the use of genomics in clinical trials to render clinical research less arduous and time consuming; and a commitment to train a new generation of physician scientists who are proficient in clinical research.

Kessler dismissed any idea of reorganization at this stage, citing a resulting continuation of morale and efficiency erosion at the agency.