FDA takes further action on drug shortages
pharmafile | November 4, 2013 | News story | Manufacturing and Production, Sales and Marketing | FDA, Obama, US, drug shortages
The FDA has taken more steps towards banishing the long-standing problem of drug shortages last week.
The agency has now published its strategic plan on the issue – which was mandated by last year’s Food and Drug Administration Safety and Innovation Act (FDASIA) – which sets out the way the FDA intends to improve its response to imminent or existing shortages and tackle the underlying causes of the problem.
It has also published a proposed rule that will require all manufacturers of certain medically important prescription drugs to notify the FDA of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt their supply.
The 40-page strategic plan includes a number of new measures, including ways to streamline the FDA’s own processes, improve the databases and tracking procedures used to monitor potential shortages, and identifying the roles and responsibility of drugmakers.
Short-term measures under consideration include allowing critical drugs to be used a little beyond their expiry date, for example, while the FDA also intends to develop standardised approaches to risk-benefit assessments before it takes action on compliance issues.
Over the long-term, the document suggests the agency will develop early-warning signals for shortages and find ways to incentivise manufacturing quality, such as public recognition of manufacturers who have demonstrated a consistent record of high quality manufacturing.
“Although FDA cannot directly affect many of the business and economic decisions that contribute to drug shortages, FDA is well-positioned to play a significant role as manufacturers work to restore lost production of life-saving medications,” says the document.
The proposed rule suggests the FDA would have to be notified of a shortage “at least six months prior to date of the permanent discontinuance or interruption in manufacturing”, and also extends the notification to biologic as well as small molecule drugs.
Currently manufacturers are only asked to voluntarily provide shortage information in accordance with an executive order by US President Barack Obama, which was issued in 2011. Since then some progress has been made: the number of new shortages in 2012 was 117, down from 251 in 2011.
ISPE programme
Meanwhile, the International Society for Pharmaceutical Engineering (ISPE) has organised a series of events throughout 2014 that will bring pharmaceutical industry stakeholders together several times in the coming year to address the issues leading to shortages in the global drug supply.
The organisation published a report on drug shortages in June 2013 which indicated that quality issues – rather than economic considerations – are the leading cause of drug shortages.
Phil Taylor
Related Content
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …
Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …
Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …
