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Policy: Health Care

FDA bureaucracy stifles access to life-saving drugs

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Opinion,Health,Op-Eds,Health Care,FDA,Pharmaceutical Industry

Ten months after a potentially deadly meningitis type B infection struck American college campuses, the federal government is finally getting around to making life-saving vaccines available to students at the affected schools.

Students at the University of California, Santa Barbara will have access to a vaccine broadly used to prevent the disease throughout the industrialized world, within “several weeks,” the Centers for Disease Control and Prevention claims, hopefully bringing one of the U.S. regulatory state’s most shameful chapters to a conclusion.

However soon the vaccines arrive in Santa Barbara, it will be too late for Aaron Loy, an 18-year-old freshman lacrosse player who underwent a double amputation after contracting meningitis B in November, more than eight months after the first case of the bacterial infection was isolated at Princeton University, 2,500 miles to the east. Loy is one of a dozen students who came down with the disease that kills, on average, 10 percent of those who contract it.

Throughout the outbreak, the Food and Drug Administration has had the needed preventative vaccine trapped in a bureaucratic sea of red tape. First developed 20 years ago, the drug has undergone extensive clinical trials, and has been tested on more than 8,000 human subjects. Regulators in Canada, the European Union, and Australia approved the drug for use well before the American meningitis outbreak, but despite its vast resources and the wealth of scientific research available on the drug, the FDA has been unwilling to approve it.

The FDA’s timeline between the first case at Princeton in March and this week’s long-awaited news that vaccines would be made available to UC-Santa Barbara students is a case study in gross mismanagement. Though meningitis B is highly contagious and can spread like wildfire in settings like colleges, where many people live together in tight quarters, the FDA waited nine months before making any available. Agency officials never offered a reason for the delay in approving the drug.

The agency then shipped a small supply of drugs to Princeton in December, but not to UC-Santa Barbara, even though both schools had equal need for the vaccine. Finally, the FDA determined this week that the vaccines could be shipped to Santa Barbara after all, in “several weeks," though the disease can maim and kill within 24 hours.

The FDA could have worked around its own red tape and expedited approval of the vaccine. That's not unusual. Recently, the FDA fast-tracked approval of a vaccine for the influenza strain H5N1, even though there had not yet been reported cases of H5N1, and the vaccine had been subjected to significantly less clinical research than the meningitis B vaccine.

These aren’t the actions of a functioning consumer watchdog. They’re the death rattles of a bureaucracy about to collapse under its own weight. The FDA is tasked with ensuring that Americans have access to safe and effective drugs. If it had done its job as well as regulators in countries with a fraction of the biotechnological capacity of the United States, Aaron Loy might still have his lower legs, and parents of students at Princeton, UC-Santa Barbara, and colleges around the nation would be breathing a little easier tonight.

It’s long past time for Washington to reform the bureaucracy that is putting our public health at risk.

Erik Telford is Senior Vice President of the Franklin Center for Government and Public Integrity. Thinking of submitting an op-ed to the Washington Examiner? Be sure to read our guidelines on submissions for editorials, available at this link.
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