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A recent Roll Call commentary (Congress, FDA Need to Act to Protect College Students, Roll Call, March 20th) indicated that the FDA has inappropriately delayed access to a meningococcal serogroup B (or MenB) vaccine in the United States. This assertion is false. In fact, the FDA is committed to responding rapidly to public health threats.
The author correctly notes that a MenB vaccine is approved in other countries. However, the FDA does not have the authority to grant approval based solely on another regulatory authority’s approval of a product. The approval of any vaccine in the United States, including a MenB vaccine, requires submission to the FDA of a Biologics License Application by a manufacturer so the FDA can review the vaccine’s safety and effectiveness. Although the law generally prohibits the FDA from disclosing the existence of pending applications, Novartis has given the FDA permission to disclose that the firm plans to submit a BLA for Bexsero (serogroup B meningococcal vaccine) to the FDA for review in the second quarter of 2014. Pfizer, which also manufactures a serogroup meningococcal B vaccine, issued a statement on March 20, in which it acknowledged receiving breakthrough designation from the FDA for its vaccine, and that it intends to submit a BLA for review by mid-2014.
As part of our commitment to protecting public health, the agency works closely with manufacturers pursuing the development and approval of vaccines, many of which are intended to prevent serious infections. The agency uses all of the regulatory tools available to the agency by law, which allows the FDA to make innovative and effective new treatment options available to patients as quickly as possible.
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 an unapproved MenB vaccine, Bexsero, available as quickly as possible to universities affected. The FDA’s 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.
The agency takes its public health responsibilities 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, M.D., director of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration