When looking over the history of the FDA, change has generally not come from within. As an agency, it requires laws to provide it with authority to issue regulations. It can only change within the parameters it is authorized. Given the fact that it has jurisdiction over about one-fourth of the economy, perhaps the ship has just become too big to steer. And perhaps it is wrong to expect bureaucrats to be visionaries, especially with leadership in such short supply.
The last time the agency had real long-term leadership was Dr. David Kessler, who managed through two Administrations of different parties to administer the agency as it met the challenges posed by Congressional reform.
But even one of his key initiatives – to regulate tobacco – failed because that type of change could not occur within the agency, it was dependent on Congress, who was unwilling to act. After Dr. Kessler, Dr. Jane Henney was at the helm, but only for about two years. The next leader of promise was Dr. Mark McClellan who talked a big talk, but then walked a big walk and left after 17 months. Dr. Crawford – 2 months. There is no denying that the agency’s lack of leadership and a rapidly changing environment have led to a decline it is effectiveness.
The last really big changes for the FDA that resulted in an improved drug approval process occurred in the 1990s when Congress passed laws that allowed the agency to speed up the process and to get life saving drugs into the hands of people whose lives were at stake. That was when FDAMA and PDUFA came into being. Driven by the demands of people with HIV, fast track and accelerated approval were brought into existence. PDUFA brought a commitment and framework to severely curb the amount of time taken to consider drugs for approval. It wasn’t a change that occurred from within, it required an Act of Congress – literally. The challenges that the agency faces today may be too big, and require leadership that is non-existent, for there to be a real restoration of the agency and to serve the goals of efforts such as the Critical Path Initiative.
Today there are several proposals for FDA Reform, including giving the agency more authority in post-marketing enforcement. How soon that reform will come up during an election year is anyone’s guess, though the pace and intensity of the reform effort may be vary depending on which party has control over Congress after the fall.
In the meantime, individuals within FDA might want to steer the ship, though it has been years since anyone really tried. But it historically it appears that it is the waves outside that push it in a new direction, not those who are working on board, especially when there is no captain.