FDA still overcautious on meningitis vaccine after student dies
posted at 3:21 pm on March 21, 2014 by Kevin Glass
Drexel University student Stephanie Ross died last week from Meningitis B, a straing of the bacteria that has been seen in recent outbreaks on college campuses. It’s thought she had contracted the bacteria while visiting friends at Prinecton University. Approval for a Meningitis B vaccine has languished, waiting approval from the Food and Drug Administration.
Jared Meyer of Economics21 points out that Princeton and the University of California, Santa Barbara have been granted special exemptions to vaccinate their students, and that the meningitis B vaccine has been used safely in the United States and around the world:
The FDA is responsible for creating an environment where a vaccine that has been proven safe and is approved for use in Canada, Australia, and the European Union cannot help Americans. Companies know the immense financial costs, time commitment, and regulatory uncertainty associated with getting the FDA’s approval for a drug. Because of this, they often hesitate at the barriers to bringing a drug to market—to the detriment of consumers.
Surprisingly, the FDA admits the vaccine against type B meningitis is safe. The vaccine is referred to as an “investigational new drug.” If the FDA agrees that the drug is safe, and has approved it for the entire Princeton and UCSB campuses, why is it still not available for widespread legal use in the United States? The answer boils down to an institutional problem that causes specific harm, and even death, to Americans.
It’s pretty universally recognized that the FDA is too slow to approve new drugs. College students are often required to be vaccinated before attending school – but none are vaccinated for meningitis B because the FDA has yet to approve the drug. These outbreaks are entirely preventable and these problems can be traced directly to the FDA.
FDA reform is something that not enough Americans get exercised about, but their archaic procedures probably impact more people on a day to day basis than most government regulations. For more on the subject, read the FDA Review, a project of the Independent Institute, which catalogues the FDA’s malpractice and options for reform.
Update, 3/25 (Ed): Meningitis B is a meningococcal disease, which is caused by bacteria and not a virus as the post originally indicated. The correction has been made above; thanks to reader Chris C for the correction.