When cases of a potentially fatal strain of meningitis began cropping up at Princeton last year, university officials trying to stop its spread could recommend little beyond precautions like frequent handwashing and not sharing beverage containers.
Although a vaccine against the rare bacteria that was causing the illness on campus existed in much of the developed world, it was not available in the United States. Novartis, its Swiss-based manufacturer, had not applied here for licensure of the vaccine, called Bexsero, because it seemed unlikely to be used enough in the United States to offset the cost of entering the market.
In all, it took nine months after the first case was detected in March 2013 before Princeton students could be immunized and nearly a year before they had completed the two-shot course, and that happened only after extraordinary interventions from the Centers for Disease Control and the Food and Drug Administration to allow the vaccine into the country.
By the end of the outbreak, seven more students had contracted the disease on the Princeton campus, and a student at another university died after contact with Princeton students. In a second outbreak involving four students at the University of California, Santa Barbara, a lacrosse player had to have his feet amputated.
The episode highlights a drug approval process in the United States that experts say does not always take into account public health needs. Regulators typically do not seek out new treatments, but wait for pharmaceutical companies to apply for approval of new products. Drugmakers weigh their estimates of sales potential against the high costs of application. And that calculation is often more fraught in the United States than in other countries, in part because American regulators are historically loath to grant approval based solely on foreign trials, so they require expensive new studies.
RTFA for all the hoops everyone had to jump through to get the appropriate treatment into the United States and available where it was desperately needed.
A second segment of the article introduces the novel notion – for the United States – that we might alter regulations and procedures to allow for need instead of profit margins. Golly.