Prescription drug safety legislation introduced in House

Democratic Reps. Henry Waxman (Calif.) and Edward Markey (Mass.) have introduced legislation (HR 1561) that they say would make greater strides toward ensuring the safety of prescription drugs than Senate legislation (S 484) introduced by Sens. Edward Kennedy (D-Mass.) and Mike Enzi (R-Wyo.), CQ HealthBeat reports (CQ HealthBeat, 3/20).

The Senate legislation would require drug regulators and companies to develop plans to monitor each new drug for side effects during its first three years on the market (Kaiser Daily Health Policy Report, 2/9).

Waxman and Markey in a release said their legislation would make enhancements to the mandatory clinical trial database that is included in the Kennedy-Enzi bill.

Waxman in a statement said, "We need only look to recent high-profile postmarket safety problems, like Vioxx, to know that our drug safety system is in desperate need of some serious improvements."

He added that while the Senate bill is "a significant step in addressing these concerns," the House bill "goes even further giving FDA the full complement of tools it needs to protect our citizens from unsafe products" (CQ HealthBeat, 3/20).