 | ISBN: 978-1-58826-241-7 $32.00 | |
| 2003/211 pages/LC: 2003047045 Also of interest: Also of interest: Health Policy by James Brasfield and Driving Down the Cost of Drugs by Ramón Castellblanch | ||
The FDA's initial mandate to protect health grew out of pharmaceutical-related disasters in the early 1900s. Later criticisms that the agency's approach impeded industry competitiveness and failed to meet public need, however, led to a political compromise on its mission. The new FDA has cut its review time nearly in half and allows direct-to-consumer advertising, off-label promotion of drugs, and the "fast-tracking" of treatments. Ceccoli convincingly shows that this approval process, while redressing valid complaints, is also creating a new complex of problems that must be resolved.
"Well organized, written, and researched, Pill Politics clearly establishes the political nature of the FDA's drug approval process.... a welcome addition."—Kant Patel, Southwest Missouri State University
"Ceccoli tackles difficult topics clearly and succinctly.... this solid and timely study of the FDA also tests important theories in public policy and the political economy of regulation."—Kevin Buterbaugh, Southern Connecticut State University