May 1, 2005
Dear Lester (or if there's a nomination hitch, To Whomever It May Concern),
As Spring is the time of new beginnings and rebirths, we would like to congratulate you on becoming commissioner of the one of the world's largest and most important government bureaucracies. You are now responsible for regulation and oversight of products that account for over a trillion dollars annually in the United States as well as the health and well-being of over 295 million citizens.
The agency that you head is currently recuperating from a series of health scares in which concerns from internal advisors about toxicities associated with certain antidepressants and widely prescribed analgesics approved by the fast-track process appeared to fall on deaf ears. Criticism of your handling of aseptic standards at a UK facility of a major flu vaccine manufacturer hasn't helped. Neither has US Republican congressmen, who cite a “crisis of confidence” in an agency that has developed an overly cozy relationship with industry. Many appear to suffer from collective amnesia, conveniently forgetting previous carping about risk aversion at the FDA and unacceptable delays in the approval of lifesaving medicines.
You and we appreciate, however, that the FDA is not in crisis. Rather, it has suffered some blunt trauma and you must now orchestrate the healing. That is why it is critical that in your role as commissioner, you now take steps to ensure that the agency further streamlines the drug approval process and addresses problems in monitoring serious adverse events.
In the next few years, it will not be pharmaceutical companies, but increasingly biotech that will be producing new experimental medicines and technologies. This means that unlike medicines of the past, which have taken decades of development, an increasing number of new drug applications at your agency will have their origins wholly or in large part in biological discoveries reported just a few years before.
As a consequence, more and more of the products under review will be unfamiliar experimental treatments, requiring new knowledge and new reference points. The increasing use of pharmacogenomic information in defining indications, as laid out in your recent Guideline (see p. 510), will only add to this knowledge-based information torrent streaming in from applicants and trial sponsors.
And yet it seems that under your leadership, the FDA is destined to move in the opposite direction. Your recent budget proposal was heavy on protecting Americans “from risky products and potential terrorist threats” but palpably light on mobilizing the increasing knowledge base of biology in the cause of better treatments. The one area you highlighted for savings was IT. Specifically, as acting FDA commissioner you commended “savings of $5,116,000 through continued consolidation and/or postponement of information technology expenditures” in order to “fully embrace the President's Management Agenda and the Secretarial priorities.”
But the FDA's IT systems are woefully outdated, even by the standards of the average office computer. In December, according to Scott Gottlieb, a former senior adviser for medical technology to the FDA commissioner, your agency requested Neurocrine Biosciences to refile its new drug application for a sleep aid called Indiplon (a pyrazolopyrimidine). This was not because the company had omitted data or because the agency had identified safety concerns. It was because the FDA could not 'navigate' the company's electronic application (rather like grandma struggling with the video remote). And then there are reports that the FDA cannot accept portable document formats (PDFs) submitted via e-mail: perhaps some of the $20 million worth of increased user fees to be collected under PDUFA (the Prescription Drug User Fee Act) could tackle the PDF deficit?
Overhaul of your antiquated computer system might also provide a solution to the process of adverse event reporting. The current system is paper based and consequently severely hobbled because it is passive and depends on the diligence of overworked physicians, who fill out and send lengthy reports, via drug companies, to the FDA. The result is your agency becomes aware of life-threatening toxicities often only months or even years after a critical mass of fatalities appear on the radar.
If you were to seriously upgrade IT, your agency could take advantage of the increasing amounts of medical data that are finding their way onto electronic medical records and into electronic prescriptions. That's why your 'to-do' list should prioritize the development of computerized systems for proactively gathering toxicity information and the refinement of algorithms for spotting potential toxic events and establishing causal links between drugs and side effects. These tools would provide a powerful complement to existing passive reporting. Indeed, you already have pilot programs underway with healthcare networks, such as the Veteran Administration hospitals and New York-Presbyterian Hospital.
It may still be unfashionable to commend European initiatives, especially among Republican congressmen, but it is becoming obvious that, at least on the question of electronic submission, the European Medicines Agency (EMEA) now leads the FDA. The FDA needs to keep pace with technological change and to foster a framework for evaluating drugs that are the fruits of secured knowledge and not mere hopeful endeavor.
It is your job to fix the FDA's inefficient and antiquated computer system. In doing so, you'll go a long way to fixing drug safety monitoring and overwork within the agency. Lester (or Whomever), it's your legacy we are concerned about. Oh yes, and other people's lives.
Sharp-eyed readers will notice that the Patents and Bioentrepreneur sections have been moved toward the front of the magazine. The Computational Biology section has also been relocated before the Research section. These changes have been implemented to bring news, opinion and feature content together, and to group technical content toward the back. Any feedback concerning these changes is welcome (email@example.com).