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Pediatric drug study costs increased nearly eightfold between 2000 and 2006, while the studies have become larger and more frequent, a study from the Tufts Center for the Study of Drug Development said.
Despite lower fourth-quarter income due to generic competition for one of its top products, Savient Pharmaceuticals saw significant earnings in 2006, according to financial results released by the company.
A recent article and editorial in the Annals of Family Medicine criticizing direct-to-consumer (DTC) advertising prompted a strong rebuttal from industry groups.
The FDA’s tentative agreement with drug and biotechnology companies to accept fees in exchange for quicker reviews of direct-to-consumer (DTC) ads is prompting criticism from industry observers who believe the plan is both a conflict of interest and a violation of the First Amendment.
The Democrats’ takeover of both houses of Congress will result in increased attention to the drug industry’s use of direct-to-consumer (DTC) advertising, but may not result in any real changes, industry observers say.
Law enforcement currently takes too prominent of a role in setting off-label enforcement policy, necessitating regulations to establish more consistent policy, an industry attorney said.
The federal government’s $435 million settlement with a subsidiary of Schering-Plough is part of a multiyear crackdown on off-label drug promotion that is likely to dramatically reduce practice, various sources say.
Pediatric drug study costs increased nearly eightfold between 2000 and 2006, while the studies have become larger and more frequent, a study from the Tufts Center for the Study of Drug Development said.