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- Title
FDA Policies and Wellness-Based Healthcare: Approving and Paying for Prevention.
- Authors
Gottlieb, Scott
- Abstract
The US Food and Drug Administration maintains an exceptionally high regulatory standard when it comes to granting claims that a product can prevent or reduce the risk of disease. The result is that the path for approval of drugs aimed at the primary and secondary prevention of disease is difficult, lengthy, and costly. Even when a preventive treatment or screening test receives the agency’s approval, Medicare may not reimburse patients for the products. The Centers for Medicare & Medicaid Services has been reluctant to open up new areas of reimbursement, especially when it comes to molecular diagnostics aimed at identifying the potential for developing disease. Yet these diagnostic tests are an essential part of clinical strategies aimed at risk reduction. The protracted regulatory approval processes for prevention and risk reduction claims, along with the unclear pathway for gaining reimbursement for these products, are slowing the development and incorporation of prevention-based treatments in our medical armamentarium. [AHDB. 2010;3(2 suppl 6):S109-S111.]
- Subjects
UNITED States; PHARMACEUTICAL policy; PREVENTIVE medicine; DRUG approval; HEALTH insurance reimbursement; CENTERS for Medicare &; Medicaid Services (U.S.); UNITED States. Food &; Drug Administration
- Publication
American Health & Drug Benefits, 2010, Vol 3, pS109
- ISSN
1942-2962
- Publication type
Article