Risk Management And Intrusions On Medical Practice: Striking A Balance

All drugs have risks. Scott Gottlieb suggests that the federal government should leave management of those risks to medical professionals. At issue is legislation to strengthen the Food and Drug Administration's (FDA's) authority and ability to manage those risks over a drug's life cy...

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Bibliographic Details
Published in:Health Affairs 2007-05, Vol.26 (3), p.678-680
Main Authors: Enzi, Michael B, Kennedy, Edward M
Format: Article
Language:English
Subjects:
Acne
Bills
Clinical trials
Corporate sponsorship
Critical path
FDA approval
Federal regulation
Legislation
Patients
Pharmacists
Pharmacovigilance
Physicians
Pregnancy
Prescription drugs
Product life cycle
Product safety
Restrictions
Risk management
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Summary:All drugs have risks. Scott Gottlieb suggests that the federal government should leave management of those risks to medical professionals. At issue is legislation to strengthen the Food and Drug Administration's (FDA's) authority and ability to manage those risks over a drug's life cycle. The Enhancing Drug Safety and Innovation Act (S. 484) would codify the FDA's authority to impose restrictions on distribution and use after approval of a drug and require those restrictions to be adapted to new information about the safety of the drug. The legislation strikes a realistic balance between risk management and intrusions on medical practice. [PUBLICATION ABSTRACT]
ISSN:0278-2715
1544-5208
DOI:10.1377/hlthaff.26.3.678