FDA rulemaking process lacks transparency, efficiency

The FDA takes an average of 7.3 years to finalize rules that determine its regulation process, a study published in the February issue of Health Affairs found. Rules associated with cost-benefit analyses take the longest to review, and longer review times often mean the final rules are less stringent than the ones proposed initially.

The Unified Agendas of Federal Regulatory and Deregulatory Actions and Regulatory Plans provide annual data on the rulemaking process. Investigators led by Harvard University graduate student Thomas Hwang used these data to identify agency rules pertaining to drugs, devices, biologics, vaccines and blood products that went into effect between 2000 and 2012 and closely examined the rulemaking process.

There were 40 significant rules the agency issued between during that time, which were about 10 percent of all the FDA’s medical product rules throughout those years. For 20 of those, the agency performed cost-benefit analyses and nine of these represented an economic impact of $100 million or more. In the other 11, cost-benefit analyses were required.

It took an average of 7.3 years to finalize these rules. The pre-rule and post-rule phases took up the most time. The entire process took longest with the rules involving cost-benefit analyses, and the economically significant rules had a combined cost of $7 billion and benefits of $11 billion. In general, as the rulemaking process carried out, the FDA’s estimated benefits decreased by 15 percent and the costs increased by 25 percent.

The agency’s Office of Information and Regulatory Affairs reviews reduced rule stringencies for the rules with longer review times. An example of a rule with such reductions included postponing effective dates for the removal of metered dose inhalers containing environmentally unsafe chemicals.

The investigators also found that about 75 percent of public comments were available in electronic format for only four of the 40 rules. About half the comments came from industry, and requests for less stringent requirements among those four rules were 12 times more likely to be generated by industry.

Based on their findings, the authors called for more transparency in the rulemaking process.

“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,” they wrote.