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.
Terri Henderson, 6, center, whose mother is El Salvador, attends a rally with members of Congress at Union Station's Columbus Circle to announce the Restore Opportunity, Strengthen, and Improve the Economy (ROSIE) Act on July 29, 2014. The legislation provides incentives for government contractors to pay a living wage and other benefits that would help low-income workers.