FDA: Killing in the Name of Safety
The recent outbreak of meningitis in Los Angeles has led to the deaths of three young men. The affected gay community has been encouraging people to get vaccinated and is even offering vaccinations free of charge.
Acting quickly is critical to battling this dangerous infection. But for the even deadlier type B strain of meningitis, taking preventative action is impossible because the FDA has not approved the vaccine.
This remains the case even though an existing vaccine, Bexsero, is unquestionably safe. It is approved for use in the European Union, Canada, and Australia, and it has been used without incident in limited situations in the United States.
Bexsero was used, after much delay, against meningitis B outbreaks at Princeton University and at the University of California, Santa Barbara. The FDA should know that vaccines are most valuable before outbreaks, not months after people have become ill.
Meningitis B outbreaks are an example of how the FDA’s antiquated and drawn-out approvals process impedes medical progress. Unfortunately, people pay for this failure with their lives.
Drexel University sophomore Stephanie Ross died in March after contracting meningitis B while visiting Princeton friends. Another victim was a promising UCSB student athlete, Aaron Loy, whose lower legs had to be amputated.
The FDA creates an environment where safe drugs cannot help Americans. Pharmaceutical companies know the immense financial, time, and uncertainty costs associated with gaining FDA approval. Because of this, they often hesitate to bring drugs to market—to the detriment of Americans.
Similar to other regulatory agencies, the FDA faces perverse incentives. If it approves drugs that end up causing harm, negative responses will be very strong. However, if it fails to approve safe drugs, it rarely receives attention. The unseen outcomes—those patients who would have been saved by pharmaceutical advances—do not generate front-page news. It is in regulators’ interests to err too far on the side of caution, even when doing so directly harms the public.
The other inherent flaw in government bureaucracies is that they are slow to change. Without market competition, they have little incentive to adapt to modern times and become more efficient.
While the inefficiencies of some government offices, such as the DMV, are comical, the FDA’s refusal to adapt to innovation when people’s lives are at stake is a serious matter. For this reason, Congress should require that the FDA use cost-benefit analyses when delaying approval of potentially helpful drugs.
Patients with terminal illnesses and their families are desperate. Yet bureaucrats are required to tell dying cancer patients they cannot try experimental drugs, even those that have been proved safe. This makes no sense. Taking a chance on these drugs at worst provides the terminally sick with hope, and at best saves lives.
The FDA has existed since 1906—before penicillin. It has had trouble keeping up with medical innovation. Personalized, effective treatment based on data analytics and DNA sequencing is possible if the FDA does not stand in the way.
As Manhattan Institute senior fellow Peter Huber argues in his new book, The Cure in the Code, 20th century law is undermining 21st century medicine. FDA policies are constraining medical progress rather than adapting to lifesaving medical innovation.
It is difficult to speed up the FDA approval process. AIDS activists accomplished this in the late 1980s, and many recall images of protestors lying with signs that read “Killed by the FDA.” Maybe the L.A. gay community, inspired by the Oscar-winning film Dallas Buyers Club and the deaths of three men in the prime of their lives, will continue this noble fight against government overreach.
It is time to stand up for medical progress and put an end to destructive FDA policies that cause needless suffering. Everyone should be free to benefit from pharmaceutical innovation. No matter what entrenched bureaucrats say, the right to self-defense does not end where FDA authority begins.
Jared Meyer is a policy analyst at Economics21 at the Manhattan Institute for Policy Research. You can follow him on Twitter here.
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