Study: Agencies Falling Short on Regulatory Transparency

Posted 24 January 2013 By Alexander Gaffney, RF News Editor

Federal agencies in the US, including the US Food and Drug Administration (FDA), could stand to do a better job at responding to public comments, claims a report out from the Government Accountability Office (GAO).

GAO's report, "Agencies Could Take Additional Steps to Respond to Public Comments," comes in response to a review initiated to probe how agencies seek public comment on proposed regulations. In advance of final regulations, agencies are supposed to issue a notice of proposed rulemaking, or NPRM. Some agencies go as far as to issue advanced notices of public rulemaking (ANPRM) if a rule is expected to generate a large amount of comments, if it is expected to be controversial or if the framework for the regulation is not yet set.

While the agencies generally comply with those regulations, some also take advantage of a "good cause" exception which allows for the publication of final rules without the NPRM. While such rules still require approval from the Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA), the public's opportunity to comment on the regulation is vastly diminished in such circumstances.

What's a 'Good Cause' Exemption?

The "good cause" exemption is met by any one of three conditions: if publication of the proposed rule would be impracticable, unnecessary or "contrary to the public interest." The former is most often used in cases when an approaching statutory deadline leaves an agency with too little time in which to seek public comment, and is used most often of the three exemptions, GAO said. In other cases, the statute specifically directed an agency to issue a rule without a NPRM or authorized it to do so. Collectively, this exemption was used in 84 out of the 123 major agency rules examined by GAO.

But even when agencies received comments, they didn't always do an adequate job in responding to them or taking them into account in the final iteration of the regulation. "This is a missed opportunity, because GAO found that when agencies did respond to public comments they often made changes to improve the rules," it said. In some cases, it may be a matter of scale. A regulation proposed by FDA that receives 10 comments is vastly different than one published by its parent agency, the Department of Health and Human Services (DHHS), that received 4,627 on what constituted a "pre-existing condition" under the Patient Protection and Affordable Care Act.

Still, every attempt should be made by agencies to respond in a transparent manner, GAO argued. "When agencies do not respond to comments requested, the public does not know whether the agency considered their comments, or if it intends to change the rule," GAO explained. "As the courts have recognized, the opportunity to comment is meaningless unless the agency responds to significant points raised by the public."

FDA Doing Well-or is it?

The good news for those keeping close tabs on FDA: It's doing a pretty good job. Only two rules promulgated by the agency were found to have skirted public notification rules using the "good cause" exemption, and in neither case did the rule involve any medical products.

The one caveat: GAO's analysis wasn't a comprehensive look at every regulation promulgated by every agency. Its 123-rule sample, culled from rules from at least as far back as 2007, could very well have missed several FDA rules meeting its standard for lack of public transparency.

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Categories: FDA

Tags: NPRM, ANPRM, Transparency, Latest News, GAO, regulations, regulatory

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