The US federal government is notoriously slow at promulgating new rules and bringing them into enforcement. But the US Food and Drug Administration (FDA) is taking that slowness to a whole new level for a host of potentially controversial final and proposed rules, some of which have lingered for decades.
On Friday, the US Department of Health and Human Services (HHS), which FDA operates under, released its semiannual inventory of rulemaking actions under development, which lists just a fraction of the rules FDA is working to either propose or finalize, and many of which have been delayed without explanation.
One of the prime examples of such a lengthy delay is for a final rule dealing with new postmarket safety reporting requirements for human drugs and biologics. First proposed in 2003, HHS now says FDA will need until March 2017, past President Barack Obama’s tenure in office, to take final action on the rule, which would further harmonize certain definitions and reporting formats with those used by the International Conference on Harmonisation.
The final rule would also add to or revise current reporting requirements for drugs and biologics, revise certain reporting time frames and propose other revisions to enhance the quality of safety reports received by FDA.
Another rule, which has been lingering since its Notice of Proposed Rulemaking (NPRM) comment period ended in 2009 (and which, last fall, FDA said would be finalized two months ago in April), would clarify how to describe the postmarket safety reporting requirements for combination products (combinations of a drug, device, and/or biologic). The finalization of that rule isn’t even on HHS’ list released on Friday.
Also not included in HHS’ list is FDA’s decision to push back the finalization of its rule on generic drug labeling, which also deals with postmarket safety and which Focus has covered extensively. That final rule is also expected to come post-Obama in April 2017 (after it was proposed in 2013, reopened for comments in 2015 and expected to be published last February). The House has even gone so far as to try to force FDA to re-write the rule.
On the device side, FDA offered a proposed rule in February 2013 that would ensure clinical investigations conducted outside the US in support of a premarket approval application, humanitarian device exemption application, an investigational device exemption application or a premarket notification submission would be conducted in accordance with good clinical practice.
FDA said in the fall of 2014 that the device rule would be finalized by January 2015, though now HHS lists (on its agenda posted 9 June) that it intended to finalize the rule sometime last month.
Meanwhile, another FDA rule, first proposed in 2006, which will reorganize, consolidate, clarify and modify current regulations concerning what companies must register establishments and list human drugs, including certain biological drugs and animal drugs, has been pushed back until sometime next month.
Also slated for release in July 2016: FDA’s amending of its current good manufacturing practice regulations to clarify and strengthen requirements for the label, color, dedication and design of medical gas containers and closures (first proposed in 2006).
“Despite existing regulatory requirements and industry standards for medical gases, there have been repeated incidents in which cryogenic containers of harmful industrial gases have been connected to medical oxygen supply systems in hospitals and nursing homes and subsequently administered to patients. These incidents have resulted in death and serious injury,” FDA explains. “There have also been several incidents involving high-pressure medical gas cylinders that have resulted in death and injuries to patients.
These amendments, together with existing regulations, are intended to ensure that the types of incidents that have occurred in the past, as well as other types of foreseeable and potentially deadly medical gas accidents, do not occur in the future.”
FDA also expects next December to propose regulations to define and implement certain statutory conditions under which compounded products may qualify for exemptions from some requirements. FDA had expected to make the proposal on 31 March.
Also Not Listed
on HHS’ agenda is FDA’s proposed rule to allow for the inclusion in device labeling of stand-alone symbols established as part of a standard developed by a national or international standards development organization, provided that such symbols are explained in the device's label. The rule also revises prescription device labeling regulations to authorize the use of the symbol statement "Rx only" on the labels.
The rule was first proposed in 2013 and expected to be finalized (as of last fall) by 31 March 2016.
The complete list of rules and their prospective dates, many of which get pushed back without any transparency or explanation, comes as Republican senators have taken issue with the way FDA is using draft and final guidance to regulate, rather than via rulemakings.
HHS Regulatory Agenda