Overhauling Drug Regulation: Senate Bill Addresses Key Deficiencies

The passage of the bill in the Senate is seen as a positive step towards addressing the deficiencies in the drug approval process. The Department of Health, Education, and Welfare's Review Panel on New Drug Regulation has identified four main issues that need to be addressed: lack of openness and public accountability, inadequate science environment at the FDA, imprecision in standards and procedures for pre-market approval, and limited FDA authority in the post-marketing period.

Former FDA commissioner Donald Kennedy has taken some administrative measures to address these problems, but the Review Panel believes that legislation is necessary to bring about significant changes. While the bill that recently passed the Senate is not perfect, it is seen as a substantial improvement over the current situation and is deserving of support.

The current system of regulation, which requires pre-market clearance of prescription drugs based on evidence of safety and effectiveness, is deemed fundamentally sound by the Review Panel. However, there is a need for greater transparency and accountability in the process. The FDA's science environment also needs improvement, and there is a call for more precise standards and procedures for pre-market approval.

Additionally, the FDA's authority in the post-marketing period is considered limited, and this is seen as a deficiency that needs to be addressed. The bill passed by the Senate is seen as a step towards addressing these deficiencies and improving the overall drug approval process.

Overall, the overhaul of the law regulating new drugs is seen as an important health policy issue. The recent study by the Review Panel has highlighted the deficiencies in the current system, and the passage of the bill in the Senate is seen as a positive development that brings about substantial improvements.