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Sunday, September 8, 2013

Sequester Cuts May Delay Drug Approvals—And More Clifford A. Hudis

Sci Transl Med
Vol. 5, Issue 201, p. 201ed14 
Sci. Transl. Med. DOI: 10.1126/scitranslmed.3007383

Sequester Cuts May Delay Drug Approvals—And More

  1. Clifford A. Hudis
  1. Clifford A. Hudis is Chief of the Breast Cancer Medicine Service and Attending Physician at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York, NY 10065, USA; Professor of Medicine at the Weill Cornell Medical, New York, NY 10065, USA; and President of the American Society of Clinical Oncology (ASCO).
  1. E-mail: hudisc@mskcc.org
Clifford A. Hudis
The U.S. Congress’s current mandatory budget cuts—sequestration—threaten unprecedented opportunities in all biomedical research and development. As a medical oncologist, these severe cuts raise the particular concern that translation of intricate knowledge about the molecular biology of cancer to new, targeted treatments will be impeded in part by an underfunded U.S. Food and Drug Administration (FDA). As of 16 August 2013, 7 of the 16 new drugs approved by FDA this year are for treating cancers (1). According to Richard Pazdur, director of the FDA Office of Hematology and Oncology Drug Products, “[T]he drugs are better,” and it is now a question of “how fast we’re going to approve them” (2). Clinical translation depends on an optimally functioning FDA, and sequestration may slow the approval process.
The pace of recent and ongoing advances is impressive by any historical comparison (particularly given the uncertain economy of the past few years). In 2012, 16 of the 39 new drugs approved were given Priority Review designation because of their potential to “provide a significant advance in medical care” (3). The priority designation requires that FDA complete its review of an investigational new drug (IND) application in 6 months rather than 10. In addition, FDA has classified 25 drugs with the new Breakthrough Therapy designation (signed into law on 9 July 2012) (4), because the drugs treat serious or life-threatening illnesses and demonstrate substantial improvement over existing therapies (5). This designation demands more interaction between the inventing company and FDA with a goal of shortening the review process. Both of these designations—along with FDA’s Fast Track status and Accelerated Approval (6)—reflect the agency’s public-health mission to speed access to safe

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