Meningitis Outbreaks Call for FDA Leadership. Don’t Hold Your Breath

Henry Miller:

 

Vaccination is one of the most important advances in public health in recent centuries, and hundreds of vaccines have all but eradicated many of the infectious disease scourges of the past. But two recent college campus outbreaks of Meningitis B (MenB), which is caused by serotype B of a bacterium called Neisseria meningitidis, or meningococcus, show that more needs to be done. What we need right now is not scientific or technological ingenuity, but more enlightened and responsive government oversight.

Since the first MenB cases were reported at Princeton University nine months ago, the federal government has taken insufficient and piecemeal steps to stem the further spread of the highly contagious and potentially deadly disease. The second outbreak has occurred at the University of California, Santa Barbara over the past month. Twelve students in all have been infected. Worldwide, there are 20,000-80,000 cases of MenB annually, with a mortality rate of about 10 percent. Of those who survive, about one-fifth suffer from devastating permanent disabilities such as brain damage, deafness, or limb loss. One UCSB case is a freshman lacrosse player whose feet had to be amputated.

As students and administrators at UCSB have learned to their dismay, there is no approved MenB vaccine in the United States although one called Bexsero, manufactured by Novartis, has been approved by regulators in the European Union, Australia, and Canada, and is available in those countries. The same vaccine is in clinical trials in the United States, but characteristically, the FDA has slowed the testing and approval process, so officials at the affected campuses have been forced to appeal to the federal government for special permission to import and administer it.

 

Why not reciprocity?? Burned by the FDA

Alex Tabarrock asks why the US FDA has to duplicate drug approvals already completed by reliable nations – e.g.. Germany, Great Britain. Is there any explanation other than aggregation of power to the bureaucracy?

If you lived in Great Britain or Germany and your physician prescribed a pharmaceutical, would you ask them, ‘has this pharmaceutical been approved by the U.S. FDA?’ Probably not. At FDAReview.org Dan Klein and I argue that international reciprocity is a no-brainer:

If the United States and, say, Great Britain had drug-approval reciprocity, then drugs approved in Britain would gain immediate approval in the United States, and drugs approved in the United States would gain immediate approval in Great Britain. Some countries such as Australia and New Zealand already take into account U.S. approvals when making their own approval decisions. The U.S. government should establish reciprocity with countries that have a proven record of approving safe drugs—including most west European countries, Canada, Japan, and Australia. Such an arrangement would reduce delay and eliminate duplication and wasted resources. By relieving itself of having to review drugs already approved in partner countries, the FDA could review and investigate NDAs more quickly and thoroughly.

Unfortunately, even when they can, the US FDA does not take advantage of international knowledge as the WSJ notes in European Sunscreen Roadblock on U.S. Beaches:

Eight sunscreen ingredient applications have been pending before the U.S. Food and Drug Administration for years—some for up to a decade—for products available in many overseas countries. The applications were filed through the federal TEA process (time and extent application), which allows the FDA to approve the ingredients if they have been used for at least five years abroad and have proved effective and safe.

…Henry Lim, chairman of dermatology at Henry Ford Hospital in Detroit and a member of the American Academy of Dermatology, says multiple UVA filters still awaiting clearance in the U.S. have been used effectively outside the country for years.

‘The U.S. is an island by itself on this one,’ he said. ‘They’re available in Canada, available in Europe, available in Asia, available in Mexico, and available in South America.’

(…snip…)

Dr