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Public Policy

What is Public Policy?

If the term seems vague to you, you’re not alone. In its most general definition, public policy guides governmental actions that promote public welfare. More specifically, these actions result in decisions about “who gets what” towards a societal goal. At the core of public policy, lawmakers and governmental agencies create the rules and policies that guide and implement programs. Because of this, policy makers are very influential. They have the power to choose where to allocate funding and resources and they create legislation and rules that govern those programs and resources. One notable example of legislated policy in the United States is the Bush administration’s 2001 decision to ban federal funding and research on new stem cell lines.

The Cancer Therapy Evaluation Program

In the case of pediatric cancer, U.S. policies are implemented through the Pediatric Section of the Cancer Therapy Evaluation Program (CTEP), which is part of the National Cancer Institute's (NCI) Division of Cancer Treatment and Diagnosis. CTEP oversees and approves federally funded clinical and preclinical pediatric oncology programs. It establishes clinical plans for new anti-cancer therapies, acts as the liaison to the Food and Drug Administration and reviews and tracks clinical protocols. It also plays an active role in managing and distributing new agents from industry and academic sources.

The mission of CTEP is to “improve the lives of cancer patients by finding better ways to treat, control and cure cancer.” CTEP accomplishes this by working with the NCI to fund an extensive national program of cancer research, including clinical trials to evaluate new anti-cancer agents.

Research and Policy 

CTEP collaborates with the research community and with the pharmaceutical and biotechnology industries to develop new cancer treatments. Experts, patients and patient advocates work with CTEP to establish research priorities and select clinical research projects for NCI sponsorship. A primary goal of the program is to fill gaps in the national cancer research effort and avoid duplication of private sector efforts, although the private sector efforts are relatively limited.

According to the Institute of Medicine (IOM) of the National Academies, a nonprofit organization that provides advice about biomedical science, medicine and health to policy makers and the public: “Despite a wealth of tantalizing leads from basic science, there is a near-complete void in commercial R&D [research and development] for pediatric cancer. As devastating as cancer is in children, the numbers affected are too small to drive innovation in the private sector.”

In response to this, the IOM developed a new approach in 2005 that joins the National Institutes of Health (NIH), academic laboratories and the pharmaceutical industry in a “virtual R&D network.” This proposed “public-private partnership,” according to the IOM, is modeled on similar networks already in place for cystic fibrosis, tuberculosis, malaria and other conditions. The approach could also eliminate the current delays in pediatric testing of new cancer drugs in development for adult cancers.

Policy in Action

An example of policy in action is the Best Pharmaceuticals for Children Act, that Congress passed in 2001 to renew an incentive for pharmaceutical companies to carry out additional pediatric research. Over the past few years, this incentive has encouraged companies to increase the number of pediatric studies being conducted.

In this case, a group called Children's Cause for Cancer Advocacy worked with Congress to ensure that the legislation addresses the needs of pediatric cancer research more directly. As a result, the bill contains provisions to broaden the mission and membership of the Food and Drug Administration’s Pediatric Subcommittee of the Oncologic Drugs Advisory Committee, allowing for greater consensus in the pediatric oncology community about priorities for testing new therapies for the treatment of childhood cancer.

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