The FDA, Where Life-Saving Medicine Goes To Die By Erik Telford
By Mel Fabrikant Saturday, December 28, 2013, 08:02 PM EST
America’s college and universities are on watch after two campuses, nearly 3000 miles apart, reported outbreaks of Meningitis type B (MenB)--a highly contagious, life-threatening bacterial infection. Outbreaks like these never would have occurred in Canada, the EU, or even Australia. Unfortunately, in America we’re forced to live in fear, as the Food and Drug Administration (FDA) needlessly stonewalls approval of life-saving drugs.
The FDA has approved vaccines for every strain of meningitis except MenB, which was responsible for 32 percent of meningitis cases in 2012. That’s not to say, however, that no such vaccine exists. A drug called Bexsero is used safely and to great effect throughout most of the industrialized world. Yet while its Canadian and European equivalents efficiently tested and approved the vaccine, the FDA has trapped Bexsero in a bureaucratic netherworld for years.
The results have been predictable. Totally preventable outbreaks of MenB have wreaked havoc on colleges in New Jersey and California, requiring at least one student to undergo a double amputation. Because the FDA obstinately refused to authorize Bexsero for distribution, students at Princeton University have continued to contract MenB, even six months after the New Jersey Department of Public Health declared an outbreak.
If the FDA had 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 (CDC), 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 Dr. 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 treatment than Bexsero.
We should be preventing outbreaks, rather than scrambling to treat them after the fact and the FDA should similarly fast-track its approval of Bexsero to prevent any further outbreaks of MenB. If the European Union and Canada have figured this out, why hasn’t the U.S.?
The FDA is supposed to serve as a consumer watchdog by preventing 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 glut, 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.
If America wants to remain the global leader in healthcare, technology, and innovation, it can’t afford to allow the FDA to continually stand in the way. Our over-reliance on the federal government to regulate our healthcare system has always been a dangerous proposition, and the FDA’s failure to adequately respond to this outbreak has called into question its seriousness about preventing disease outbreaks. By expediting its approval of Bexsero, 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.