The Food and Drug Administration is at it again. Despite a recent outbreak of type B meningitis at the University of California, Santa Barbara, the FDA will not allow students to be vaccinated against the disease, placing UCSB’s 20,000 students in harm’s way.
This form of the disease is rare, but deadly. Yet a vaccine against the B strain is approved for use elsewhere, but not in the United States. Authorities in the European Union, Australia, and Canada have all verified its safety. Last month, Princeton University students were granted special approval by the FDA to receive the vaccine after pleas from the Centers for Disease Control and Prevention.
At that time, I argued the latest cure should not be restricted only to those who attend Ivy League schools. Hypothetically, I asked, “What if the eight victims were spread throughout the country, or came from less prestigious intuitions? Would the CDC have allowed the use of an unapproved drug?” Now we know the answer—regulators will not provide less fortunate students with equal opportunities for treatment.
The UCSB students are still waiting for FDA approval. This remains the case even after three cases of type B meningitis were reported at the school. One victim was a promising student athlete, Aaron Loy, whose lower legs had to be removed. After an investigation, the CDC amended its letter to the FDA to request extending special permission to UCSB students because of the danger posed to the student body.
Even if the CDC concluded there was a low risk of further outbreak, there are no reasonable arguments to support legally prohibiting people, at their own expense, from purchasing vaccines—or other drugs—that have been proven safe and effective.
It is confusing why there is any delay in approval at all. It was irresponsible for the FDA to expose vulnerable Princeton students while a vaccine was readily available and in use in other first-world countries. It is morally reprehensible for the FDA to further delay allowing UCSB students to receive the same treatment as their Ivy League counterparts.
The FDA’s misregulation highlights one of the main problems with government bureaucracy. While the FDA was created with the best of intentions—to protect consumers—the organization has grown so incompetent it now harms the very consumers it is tasked with protecting.
Similar to other regulatory agencies, the FDA faces perverse incentives. If it approves a drug or product that ends up causing harm, the negative response will be very strong, and bureaucrats may lose their jobs. However, if it fails to approve something that will cause no harm, it receives little, if any, response. The unseen outcomes—those patients who would have been saved by medical or pharmaceutical advances—do not generate front-page news. Simply put, it is in regulators’ interests to err on the side of caution, even when doing so directly harms the public.
The other inherent issue with regulators is that they are slow to change. Without market competition, government organizations have little incentive to become more efficient. The FDA exemplifies this problem, and in doing so inhibits the effectiveness of modern medicine.
In his new book, The Cure in the Code, Manhattan Institute senior fellow Peter Huber argues that 20th century law is undermining 21st century medicine. Modern treatments may work for one patient, but not for another. Huber writes that this should come as no surprise. As medical advances become more individualized, the proportion of patients positively affected by treatments will likely shrink. But, the availability of specialized treatments will continue to grow, greatly benefiting patients—especially the terminally ill—if the FDA does not stand in the way.
Sadly, the organization appears to be doing just that. Last week, Hudson Institute distinguished fellow Christopher DeMuth, together with his son, fund manager Christopher DeMuth, Jr., described problems with the FDA’s approach to clinical trials in the face of medical advances. The DeMuths argued that the FDA's outdated doctrine “leaves the agency with wide discretion, at the end of years of development and evidence, to say ‘no’ or ‘tell us more.’ ”
The DeMuths were discussing the FDA’s overzealous review of the MS drug Lemtrada. Similar to the type B meningitis vaccine, this drug was found to be safe by 30 other countries’ regulatory bodies. The drug is clearly safe and effective, but it was unable to pass FDA review due to structural issues with double-blind trials. In effect, the FDA is doing its best to constrain medical progress rather than adapt itself to lifesaving medical innovation.
In business, the bottom line of profit provides continuous challenges. Private businesses undertaking unsuccessful experiments have no choice: they must recognize their mistakes or go bankrupt. Bureaucracies lack the crucial loss component of the profit and loss system. They instead have incentives to grow, resist change, and delay action.
Alternatively, drug manufactures are still businesses. They earn revenue through free exchanges with customers. These customers would not line up to buy pills from brands that have histories of killing patients. Healthy, living customers are vital to drug companies’ successes—the profit motive provides strong incentives against killing customers.
Sometimes companies make mistakes or create negative consequences for third parties. But, because of competition, these market failures are usually preferable to government failures, such as the FDA’s. This must be acknowledged when evaluating the costs and benefits of regulations.
The FDA has tremendous power over Americans’ lives. While the inefficiencies of some government offices, such as the Department of Motor Vehicles and the U.S. Department of Energy, are almost comical, refusing to recognize innovation when people’s lives are at stake is a serious matter. The FDA should follow the example of Europe, Canada, and Australia, and immediately approve the vaccine for type B meningitis for the entire country, not just for a few privileged Princetonians.
Jared Meyer is a policy analyst at Economics21, a center of the Manhattan Institute for Policy Research. You can follow him on Twitter here.