While much energy has been focused on the US Food and Drug Administration (FDA) during the shutdown of non-critical governmental operations, another regulatory entity has also been affected, one whose approval is essential to the publication of regulations and guidance.
That entity is known as the Office of Information and Regulatory Affairs (OIRA), an office of the White House's Office of Management and Budget (OMB). The office is essentially a meta-regulator, overseeing the regulations of all federal agencies, including those of FDA.
OIRA generally works quietly and behind the scenes, offering minor critiques in most cases and serving as a clearinghouse of economic information on proposed documents. In some cases, however, it has contributed to significant delays of some regulations, most notably FDA's Unique Device Identification (UDI) rule and a laser products rule, both of which were released earlier this year after more than 12 months of delays each.
The intent of OIRA is to ensure that the executive branch is operating with a degree of oversight and accountability. As a result, a sign-off from the office is required for any regulation, guidance, meeting or collection of information (think polls or studies) that an agency wants to conduct.
Delays Even During Normal Times
But in recent years, the office has come under considerable criticism by some groups, who complain that the office has contributed to the delays of many rules that could stand to significantly benefit consumers.
One frequent voice of criticism has been the Center for Progressive Reform's (CPR) Rena Steinzor. Writing yesterday in a Huffington Post opinion piece, Steinzor charged that OIRA's process has "Evolved into a gauntlet for public health [initiatives]."
"Agencies doing their best to implement statutory mandates in a reasonable timeframe are subjected to withering rule-by-rule reviews. The process is analogous to examining the branches of individual trees without realizing that they are part of a dying forest; this myopia has obscured the causes and effects of regulatory failure for five presidents from both parties."
Even when it's working at its best, Steinzor continued, the office serves as a "bottleneck for protective regulation," often taking far longer than is statutorily mandated to review documents.
Get Ready for Delays
So what has OIRA been doing with FDA documents during the shutdown? From the looks of it, absolutely nothing.
A review of the OIRA website shows that the office has not processed any documents from FDA since 30 September 2013, and has not approved any since 27 September 2013. It has not processed or approved any documents from the US Department of Health and Human Services (DHHS) since 30 September 2013.
This could lead to significant delays in the near future. Under its user fee programs, FDA is bound to issue certain guidance documents and regulations by specific dates. Delays could be forthcoming, even assuming FDA releases them on time-a big if, considering FDA's website seems to imply that guidance development is not among its ongoing activities.
Work at a Standstill
A review of OIRA's website shows that it has 117 information collection review (ICR) documents awaiting review from DHHS, of which 13 are from FDA. OIRA also has eight regulations (proposed and final rules) awaiting approval from FDA, some of which have been sitting at the office since December 2011.
So if FDA has a backlog of documents to send to OIRA, and OIRA has a backlog of documents it still needs to get through before it can even start looking at the new ones, industry is presumably in for one thing: delays.
And while some of those delays may be welcomed, others are less likely to be. There are several guidance documents called for under the Food and Drug Administration Safety and Innovation Act (FDASIA) that have yet to be released, among them one on interactive reviews, devices that can be approved under humanitarian device exemptions and sold for profit, and a proposed rule to require the submission of pediatric study plans.
All of these documents were supposed to be released around September 2013, meaning it could be a while before industry sees the release of any new documents out of FDA.
Focus has reached out to FDA for comment on whether guidance and rulemaking development is ongoing and will update this piece if they respond.