The FDA: Where Life-Saving Drugs Go to Die

The FDA: Where Life-Saving Drugs Go to Die
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America’s colleges and universities are on watch after two campuses, nearly 3,000 miles apart, reported outbreaks of Meningitis B (MenB) -- the highly contagious, life-threatening bacterial infection that was responsible for 32 percent of meningitis cases in 2012. Outbreaks like these never would have occurred in Canada, the EU, or Australia: There, citizens have access to a MenB vaccine called Bexsero. Unfortunately, in America we’re forced to live in fear as the Food and Drug Administration needlessly stonewalls its approval of this drug.

The totally preventable college outbreaks, in New Jersey and California, have required at least one student to undergo a double amputation. Students at Princeton University continued to contract MenB six months after the New Jersey Department of Public Health declared an outbreak.

If the FDA found cause for concern during its evaluation, its delay in approving the vaccine might be sensible, but it hasn’t provided a reason for the holdup. Even the Centers for Disease Control and Prevention, the FDA’s sister organization tasked with promoting public health, has cast doubt upon the validity of the FDA’s roadblock. Last month, CDC meningitis expert Amanda Cohn recommended the drug to treat and prevent future MenB outbreaks.

Moreover, the FDA has the authority to circumvent its own customary red tape and expedite approval of drugs in response to life-threatening outbreaks like this. In fact, it’s not all that uncommon. Just last month, the FDA fast-tracked approval of a vaccine for the influenza strain H5N1 -- a decision that will certainly save both lives and millions of dollars in care and treatment. However, at the time of the drug’s approval, there had been no reported cases of H5N1, and the vaccine had been subjected to far less rigorous evaluation than Bexsero has today.

The FDA is supposed to prevent corporations from marketing unsafe and ineffective medical products. However, like so many other government agencies born out of the best of intentions, the FDA has ballooned into an unrecognizable bureaucratic monster, standing in the way of medical innovation. For too long we’ve allowed government inefficiency to dictate the pace of life-saving achievements in medicine, and now we’re paying the price.

We should be preventing outbreaks rather than scrambling to treat them after the fact, and the FDA should fast-track its approval of Bexsero. If America wants to remain the global leader in health care, technology, and innovation, it can’t afford to allow the FDA to stand in the way. Our reliance on the federal government to regulate our health-care system has always been a dangerous proposition, and the FDA’s failure to adequately respond to this outbreak has called into question the agency's seriousness about preventing disease outbreaks. By expediting its approval of Bexsero, the FDA can stem future MenB outbreaks and inoculate American students still at risk of contracting this deadly disease.

Erik Telford is senior vice president of the Franklin Center for Government and Public Integrity.

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