FDA Says Hurricane Sandy Will Affect Review Target Dates, Regulated Industry

Posted 05 November 2012 | By Alexander Gaffney, RAC 

Hurricane Sandy left much of the US' eastern seaboard battered and flooded after coming ashore in late October, and the damage and delays it caused are having regulatory implications, the US Food and Drug Administration (FDA) said in an announcement.

In a 1 November 2012 statement, FDA Commissioner Margaret Hamburg said her agency was heavily focused on the storm and its potential to affect regulated industry.

"We often think of major storms like Sandy in terms of the risk to life and damage to property," Hamburg wrote. "But at FDA we also have to focus on the effects of natural disasters on the safety of the products we regulate and that consumers and patients depend on" - including medicines and medical devices.

Continued Hamburg: "Flooding, extreme temperatures, and power outages can create a multitude of safety problems for those products and the facilities where they are made and stored."

The commissioner highlighted FDA's use of a geographic information system (GIS), which plots the physical location of all regulated facilities on a map, which can then be paired with weather data to determine the likely effect of a storm on a particular company or area. "This information prepares FDA offices across the country to act immediately in the event of a natural disaster by showing us the location of the affected facilities," Hamburg explained.

In the wake of the storm, Hamburg said FDA is in the process of reaching out to potentially affected companies to determine which manufacturing facilities need to be re-inspected, and which inspections need to be prioritized. "As we assess the damage, we need to inspect facilities and focus on situations that pose the greatest risk to public health and safety," Hamburg added.

Review Dates Delayed, Disrupted

But even in Washington, DC, where Sandy had little physical impact, FDA's regulatory operations have also seen disruption. The Office of Personnel Management (OPM), the federal office charged with closing and opening government facilities, shut down FDA for two days as the storm bore down on the region (29-30 October).  

The closure of its offices for two days would not be without consequence for sponsors with target dates around those two days, the agency said. Products covered under the Prescription Drug User Fee Act, Medical Device User Fee Act, Biosimilar User Fee Act and other user fees are ascribed target dates by which FDA aims to make an approval decision.

For products being reviewed during this time, FDA said it will, "Assess the practicality of meeting the goal and will extend the goal as needed, but no more than the number of business days that the federal government and FDA buildings were closed." Some-but not all-applications will be affected, largely depending on if the application was at the start or end of its review cycle.

Closures may also have affected the delivery of applications to FDA, and the agency said in a statement that, "The closure may present issues regarding calculation of applicable review or regulatory clocks."

"The effective receipt date may depend on the type of submission (e.g., electronic versus paper submissions) and when the FDA center to which the submission was sent resumed its document receiving services, among other factors," wrote FDA. Sponsors should contact the appropriate review division to determine the date of submission recognized by FDA, it said.


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