An April 10 Manhattan Moment op-ed by Jared Meyer indicated that the Food and Drug Administration has inappropriately delayed access to and approval of a serogroup B meningococcal (or MenB) vaccine in the United States.
This assertion is false. FDA is committed both to responding rapidly to public health threats and to approving products for serious medical conditions in a timely manner.
While infections caused by MenB are uncommon in the U.S., they can be very serious. Under the FDA's expanded access program for investigational products, the agency has worked closely with the Centers for Disease Control and Prevention to make the unapproved MenB vaccine, Bexsero, available as quickly as possible for use on two college campuses. The expanded access program allows the use of an investigational drug, including a vaccine, that is not approved in the U.S. to treat or prevent serious or immediately life-threatening conditions when no comparable or satisfactory approved therapy is available. The FDA stands ready to work with CDC as needed moving forward.
In addition, the approval of any vaccine in the United States requires submission of a Biologics License Application to the FDA by a manufacturer so that the FDA can review the vaccine's safety and effectiveness. Novartis and Pfizer, two manufacturers that are developing vaccines to address MenB, have made public that they intend to submit such license applications as early as mid-2014. We are committed to reviewing the applications as quickly as possible.
In fact, both Novartis and Pfizer have publicly acknowledged that the FDA has granted breakthrough designation for their MenB vaccines. Breakthrough Therapy Designation, a provision of the FDA Safety and Innovation Act of 2012, provides for intensive collaboration between the FDA and drug developers and allows the agency to use all available tools to expedite safe and effective drugs or biologics for serious conditions to the market. This includes an agency commitment to finish its review of marketing applications within six months.
The FDA takes its public health responsibilities very seriously and is committed to working with manufacturers to bring important medical products to patients. The health and well-being of patients is the agency's top priority.Karen Midthun is director of the Center for Biologics Evaluation and Research at the Food and Drug Administrationâ€©â€©Thinking of submitting an op-ed to the Washington Examiner? Be sure to read our guidelines on submissions for editorials, available at this link.