Article: Increased Scrutiny Expected In Monitoring Phase IV Studies.

Article from:
BIOWORLD Today
Article date:
November 4, 2009
Copyright

Washington Editor

WASHINGTON - When a drug company asks the FDA to clear a product for marketing, the parties often agree that the company will conduct a postmarketing, or Phase IV, study.

So the company gets clearance and subsequently begins pumping its drug into the market. Meanwhile, the FDA goes back to work and the two never meet again unless serious problems surface with the drug.

At least that's what one member of the House of Representatives contends.

Rep. Bart Stupak (D-Mich.) had the chance to question Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), in reference to the agency's practices ...

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