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Manhattan Moment: FDA's outdated review process leaves people dying for drugs

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Opinion,Health,Op-Eds,Obamacare,Health Care,FDA,Manhattan Moment

A 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. This quick response likely prevented further deaths. Unfortunately, similar preventative action is impossible for the equally deadly meningitis B strain while the vaccine awaits Food and Drug Administration approval.

The vaccine in question, Bexsero, is unquestionably safe. The European Union, Canada and Australia have already approved the vaccine, and it has been used without incident in limited situations in the United States.

After much delay, the FDA allowed Bexsero to be used against meningitis B outbreaks at Princeton University and at the University of California, Santa Barbara. The medical experts at the FDA should know that vaccines are most valuable before cases appear, not months after people have become ill.

These meningitis B outbreaks, which Bexsero could have prevented or curtailed more quickly, are just one 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, promising UCSB student athlete Aaron Loy, had to have his lower legs amputated.

The FDA’s outdated review process creates an environment in which safe drugs cannot begin helping Americans because of administrative backlog. The immense costs and uncertainty associated with gaining FDA approval also makes companies hesitant to develop new drugs — to the detriment of Americans.

The FDA faces perverse incentives: If it approves drugs that end up causing harm, negative responses will be very strong, but the public rarely knows if the FDA fails to approve safe drugs. 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.

Although the inefficiencies of some government offices, such as the DMV, are rather comical, the FDA's refusal to adapt to innovation when people's lives are at stake is a serious matter. Because of this, the FDA should use cost-benefit analyses when delaying approval of potentially helpful drugs.

The FDA has existed since 1906 — before penicillin — and is showing its age. Personalized, effective treatment based on data analytics and DNA sequencing is possible if an outdated FDA does not stand in the way. However, without market competition, the FDA has little incentive to adapt to modern times and become more efficient.

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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