Proposed FDA Reforms Address Phase IV Studies, Patient Protection Office

Two prominent Democratic senators have announced FDA reform plans -- one calling for the government to require certain postmarketing studies on drug products, and another proposing the creation of a new drug safety watchdog office under the auspices of the FDA commissioner.

The separate bills, by Sens. Edward Kennedy (D-Mass.) and Christopher Dodd (D-Conn.), aim to address recent drug safety issues, including the discovery of adverse cardiovascular events related to the use of Cox-2 inhibitors and the link between antidepressant use and suicidal behavior in children.

Kennedy's Affordable Health Care Act, S. 16, would authorize HHS to require drug sponsors to conduct Phase IV studies if certain safety issues surface about the product after it's approved, including through the FDA's MedWatch postmarket surveillance system, epidemiological studies or scientific literature.

Dodd's proposed Patient Protection Act of 2005, calls for establishing a new Office of Patient Protection (OPP), which would remain in the FDA but would report directly to the FDA commissioner. OPP would have independent authority to act to protect patients, according to Dodd's announcement. The bill creates a new "watchdog office in the FDA" that could pull drugs off the shelf if they are deemed to be unsafe for patients, he said. Dodd would appropriate $100 million annually to fund OPP.