Quantifying The Food And Drug Administration's rulemaking delays highlights the need for transparency.
The Food and Drug Administration (FDA) frequently uses its rulemaking process to establish or modify the way it regulates drugs, medical devices, and other medical products. The federal agency's rulemaking is controversial because of its perceived complexity, lack of transparency, and lengthy duration. To shed light on the FDA's rulemaking process, we examined the evolution of significant rules that the agency published during 2000-12 for drugs, devices, and other medical products. We found that the rules' median time to finalization was 7.3 years, with the pre-rule phase and postreview deliberation within the FDA accounting for the majority of that time. Rules that involved mandatory cost-benefit analyses were associated with an additional delay of approximately two years. We also found that longer review times were significantly associated with a reduction in the stringency of final rules, compared to the originally proposed versions. We recommend improving FDA's rulemaking by allocating additional resources to increase efficiency and by embarking on initiatives to promote transparency by the FDA and other parts of the executive branch.
Thomas J
TJ
Hwang
Jerry
J
Avorn
Daniel
D
Carpenter
Aaron S
AS
Kesselheim
D003362:Cost-Benefit Analysis; D003657:Decision Making; D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005260:Female; D006801:Humans; D008297:Male; D020380:Needs Assessment; D017008:Negotiating; D011050:Policy Making; D011057:Politics; D018709:Statistics, Nonparametric; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
Legal/Regulatory Issues; Medical technology; Pharmaceuticals