I think that it's no great surprise that many people see the US Food and Drug Administration (FDA) and its ilk in other countries as a gargantuan ball and chain dragging down progress. Yet few of these take the fully libertarian position that the FDA should be removed and the demand for safety assurance provided by a marketplace of review and certification organizations. Instead most such advocates argue for a return to the smaller FDA and much less onerous review process that existed in the past. They note that FDA administrators have perverse incentives to block as much progress as possible, and that they have followed these incentives across recent decades to greatly increase the amount of time and money required to obtain approval for new medical technologies.
FDA bureaucrats are blamed for letting through any technology that causes even a tiny amount of harm, while receive no personal benefit for approving something that is safe, and receive no personal penalty from slowing down or blocking perfectly safe technologies from approval. There is no such thing as a perfectly safe medical technology: it is always a cost-benefit analysis for even the most beneficial technologies developed to date, and the mass media tends to inflate every harm done without taking account of the benefits. Everything else proceeds from that, and the consequence is that ever fewer new medicines are approved, there is less funding for development, and many lines of research are abandoned because the cost of regulatory compliance has become too great.
The situation is actually much worse for aging research, as the FDA doesn't recognize aging as a medical condition that can be treated; there is no path through the regulatory process to obtain approval for a treatment for aging, and that fact echoes back down the funding chain to make it much harder to raise money for projects such as SENS rejuvenation research. Potential technologies for the treatment of aging would at best have to be shoved through the approval process as narrow therapies for specific age-related conditions, which may well have a distorting effect on development. Some people are less concerned by this than I am, but changing what the FDA considers to be a disease is a long process of lobbying. This costs money and time that would be better spent on research. Just look at the years of attempts to get FDA bureaucrats to consider sarcopenia a medical condition: that is still going on, with no end in sight.
A number of political advocacy organizations have been founded in past years with the intent of trying to cut down the influence, size, and costs imposed on medical development by the FDA. In most cases they are focused on the time cost rather than the financial cost, possibly because that is an easier rallying cry. These organizations are one of the expressions of frustration with a regulatory process run wild, that serves only itself, and is causing far more harm than good. People don't see the invisible cost of medicines not development and technologies delayed for years. Faster Cures is one of the earlier organizations, now with interests in many approaches to speeding up research, including the venture philanthropy ideals that have been expressed by Peter Thiel for some years. But today I'll point out another lobbying organization created by those frustrated by the FDA and its baleful influence on the pace of medical development:
Tomorrow's Cures Today Foundation
Millions of Americans are in pain and suffer needlessly. Thousands of Americans die unnecessarily as they wait for promising new drugs to make their way through an unnecessarily long approval process. What we see is death and suffering that is attributed to approving drugs with dangerous side effects; but what we don't see is the death and suffering due to regulatory delay. Those victims are invisible.
Rob Donahue used to ride horses. He was a modern-day cowboy until he was stricken with amyotrophic lateral sclerosis (ALS). Now his muscles are weak. He can't ride horses anymore. And his condition is worsening quickly. ALS will degenerate Donahue's neurons and nervous system, and he will probably die in less than five years. Another ALS sufferer, Nick Grillo, is trying to change all that. He's put together a petition on Change.org to urge the FDA to fast-track approval of a new drug, GM-604, that would help people like Donahue and others like him. "People can't wait five, ten, 15 years for the clinical trial process," said Grillo. "Things need to happen much quicker." But ALS is just one illness, and GM-604 is just one medicine. There are thousands of Americans suffering -- many with terminal illnesses -- while waiting on the FDA approval process.A paradigm change is essential because FDA culture has led to a situation where it costs an average of $1.5 billion and 12 or more years of clinical testing to bring a new drug to market. Medical innovation cannot thrive when only very large firms can afford to research and develop new drugs. Another problem is that the FDA's first goal is not to maximize innovation, but to minimize the chances that an FDA-approved drug leads to unanticipated adverse side effects and negative publicity. In particular, the FDA's efficacy testing requirements have resulted in an ever-increasing load of money and time on drug developers. We can't count on FDA bureaucrats to fix the broken system they created. Even Congress, whose cottage industry is to regulate, admits that the current FDA system is a roadblock to fast-paced innovation.
The missing seat at the table is for someone who represents freedom -- that is, the right of patients, advised by their doctors, to make informed decisions as to the use of not-yet-FDA-approved drugs. Absent from the congressional hearings over health care, however, has been a freedom agenda, specifically one designed to eliminate the FDA's monopoly on access to new drugs. We hear very little about those who suffer and die because they were not able to access drugs stuck in the FDA's testing pipeline, or about drugs that were never brought to market because FDA procedures made the development costs too high. There is an invisible graveyard filled with people who have died because of drug lag and drug loss. The FDA's deadly over-caution is why venture capitalists shy away from investing in biopharmaceutical startup firms. Venture capitalists are willing to take big risks on ideas that may fail. But failure due to regulatory risk is just too big a hurdle to overcome. Capital providers have other opportunities, even if those opportunities don't involve cures for disease.
High costs and slow innovation are the hallmark of a monopoly. And, as medical science continues its rapid pace of innovation, the cost of lost opportunities for better health will increase even faster. The solution is to introduce consumer choice and competition. FDA proponents would bolster the fear that "unsafe" drugs could flood the marketplace. But the FDA cannot define what is "safe." Only patients with their unique health conditions, treatment profiles, and preferences for taking risk can define what is safe for them.
View the full article at FightAging
