FDA Kicks Pharma, Device Rule Finalizations Down the Road, Past Obama’s Presidency

The US federal government is notoriously slow to establish new rules and apply them. However, the Food and Drug Administration (FDA) is taking this slow to a new level for a variety of potentially controversial proposed and final rules, some of which have persisted for decades.

On Friday, the Department of Health and Human Services (HHS), which operates under the FDA released its semi-annual inventory of actions for the development of regulations under development, which lists a fraction of FDA standards or work propose or End and many of which have been delayed without explanation.

Security Subsequent Marketing

One of the first examples of such a prolonged delay a final rule is facing new requirements for reporting on the post-market drug products for human use and biological security. First proposed in 2003, the FDA now says HHS will need until 2017 last March under President Barack Obama in office, to take the final action of the rule, which further harmonize definitions and reporting formats with used by the International Conference on harmonization.

The final rule also add or revise the existing reporting requirements for drugs and biologics, to review certain deadlines for reporting and suggest further changes to improve the quality of safety reports received by the FDA.

Another rule, which has been persistent since the regulation of proposed rulemaking (NPRM) comment period ended in 2009 (and, last fall, the FDA said it would be completed two months ago in April) clarify how to describe the information requirements post-marketing combination products (combinations of a drug, device and / or biological) security. The completion of this rule is not even on the list of HHS 'on Friday.

Furthermore, it is not included in the list of HHS 'is the decision of the FDA to delay the completion of its rules on the labeling of generic drugs, which also deals with the post-marketing and widely covered approach to security. It is also expected that this rule to come post-Obama in April 2017 (after it was proposed in 2013, open to comments in 2015 and should be published in February). The house was still trying to force the FDA to rewrite the rule.

Test Devices

On the device side, the FDA proposed a rule proposed in February 2013 to ensure clinical investigations conducted outside the United States in support of an application for premarket approval, the request for exemption from humanitarian system, an application for exemption investigational device or submission notification for marketing will be carried out in accordance with good clinical practice.

According to the FDA, in the fall of 2014 that the rule that the device could be completed in January 2015, but now lists HHS (in the agenda published on 9 June) that it intends to terminate the rule sometimes the last month.

Another Delay

Meanwhile, another rule FDA first proposed in 2006, reorganize, consolidate, clarify and amend the rules governing what companies must register establishments and list of medicinal products for human use, there including some biological drugs and animal drugs , it has been postponed until next month times.

It also goes on sale in July 2016: the change in FDA regulations for good current manufacturing practices to clarify and strengthen requirements for the label, color, dedication and design of medical gas containers and closures (first proposed in 2006).

"Despite regulatory requirements and industry standards of medical gas, there have been repeated incidents in which the cryogenic vessels of harmful industrial gases have been linked to the systems of medical oxygen supply in homes hospitals nursing and then administered patients. These incidents resulted in death and serious injury, "says the FDA." there have also been several incidents with medical gas bottles high pressure that led to death and injury to patients.

These changes, as well as current regulations are intended to ensure that the types of incidents that occurred in the past are produced, as well as other types of medical gases and potentially fatal accidents not predictable in the future. "
The FDA also expected next December to propose regulations to define and implement certain legal conditions under which aggravate products are eligible for exemption from certain requirements. FDA had planned to make the proposal on 31 March.

Also Unregistered

Nor on the agenda of HHS is the rule proposed by the FDA to allow inclusion in labeling of the symbols of autonomous devices established via a standard developed by an organization of national or international standards, provided that these symbols are explained in the unit label. The rule also revises the rules on labeling of the unit in order to allow the use of the statement symbol "prescription only" on the label.

The rule was proposed in 2013 and expected to be finalized (last fall) 31 Mar 2016.

The complete list of rules and possible dates, many of whom rejected without any transparency or explanation, as Senate Republicans questioned how the FDA uses the project and the final orientation regular, rather than through d regulatory Action