Risk Evaluation and Mitigation Strategies (REMS) are the newest tool of the FDA to help manage and ensure safe drug use. REMS are a particularly important issue for oncology, because a disproportionate number of drugs with complex REMS are used in patients with cancer or hematologic disorders.

The Avandia issue has shed light on important issues in FDA regulation, including politics and regulating the practice of medicine.

Efforts to limit the commercial use of data on physician prescribing could have broad implications for regulatory programs that promote drug safety. At issue are a series of laws pursued by state legislators that would restrict access to information on the prescriptions written by individual doctors.

Congress seems increasingly intent on usurping the judgment of doctors. This will hit the poor especially hard.

The expansion of risk-management tools is an imprecise solution to the wrong problem.

Review of Neoconservatism by Irving Kristol.