Congress, FDA Need to Act to Protect College Students | Commentary
Last week, a Drexel University sophomore named Stephanie Ross had her life cut short by meningitis, a highly contagious bacterial infection that can wreak havoc on college campuses and other high-density living environments. Ross, 19, was a mechanical engineering major at Drexel, which requires students to receive all available meningitis vaccinations before enrolling. But tragically, the vaccine that treats the strain of meningitis in question — that is, the vaccine that could have saved Ross’ life — is suspended in regulatory purgatory, and the federal government continues to put millions of college students at risk by refusing to expedite its approval.
Meningitis type B, the strain of the disease that Ms. Ross is believed to have contracted, has terrorized college campuses across the country for the past year, infecting more than a dozen students at Princeton, UC-Santa Barbara, and now Drexel, a private university in Philadelphia with more than 15,000 undergraduate students. MenB is responsible for about a third of U.S. meningitis cases, but is the only strain not currently preventable by an FDA-approved vaccine. Yet that’s not to say that no such vaccine exists —rather, the MenB vaccine is readily available and in use throughout most of the industrialized world.
Bexsero, a drug tested on more than 8,000 human subjects and approved for use in Canada, the European Union and Australia, has proven to be a safe and effective method of treating MenB, but the Food and Drug Administration has presumably kept it tied up in red tape for years. Multiple outbreaks have occurred on American college campuses as a result, leading to physical deformities and death.
Because the FDA has not approved Bexsero, the U.S. has been forced to reactively post-treat these deadly outbreaks instead of proactively preventing new cases. After the first case of MenB was isolated at Princeton over a year ago, the FDA should have moved quickly to approve the vaccine for widespread use. Instead, at least seven additional students contracted the disease, which on average kills about 10 percent of those affected. While Princeton was waiting for its vaccines, a second strain of MenB broke out 3,000 miles to the west at UC-Santa Barbara, causing one freshman lacrosse player to have his feet amputated. The government’s response to these outbreaks was so delayed that some parents sent their children out of the country to be vaccinated before allowing them to return to campus.
The FDA needs to set aside its unwillingness to circumvent its own bureaucracy, stop pointing fingers, and take action to prevent further MenB outbreaks. It can begin by granting a fast-tracked special license for Bexsero, as it has done on many other occasions in attempts to prevent infectious outbreaks, most recently with a vaccine for the H5N1 strain of influenza. The federal government also needs to develop a rapid response procedure so that communities afflicted by these outbreaks are not left waiting months for life-saving medicine.
The buck stops with Congress, which oversees the FDA and must hold it accountable. A year after the initial MenB outbreak at Princeton, the FDA still has not approved Bexsero, and Congressional overseers should investigate ways to make the agency more nimble and responsive. For instance, Congress should pursue reciprocity policies with nations that have available quantities of the vaccine, which may provide an alternative pathway for vaccines to come to the U.S. market.
Reciprocity policies would hardly be ground-breaking territory for the FDA, as the agency already works with many of its foreign counterparts to harmonize international regulatory standards. As scholars at the Manhattan Institute have noted, if the FDA and other advanced regulators have “(largely) the same safety standards, there should at least be reciprocal approval for vaccines (and likely many drug classes as well) where the biological understanding of the underlying mechanisms of action are well understood.”
The government’s decision to import small quantities of the MenB vaccine on an ad hoc basis instead of making it available nationally seems to invite tragedy, which sadly struck last week in Philadelphia. Had Ms. Ross attended a university in Toronto, London or Sydney, among other cities, she would long ago have had access to drugs that —in all likelihood — would have saved her life. But because of her government’s failure to mitigate an emerging public health crisis, she, her classmates, and millions of other college students were left vulnerable to the disease — and it’s long past time for Washington to deliver them the protection they need.
Erik Telford is senior vice president of the Franklin Center for Government and Public Integrity.