FDA updated a guidance for industry on serious adverse event reporting. The agency said it anticipates that some companies will have high absenteeism during the coronavirus pandemic, or they will have sent some non essential employees home, which could include regulatory compliance personnel.
The agency said companies may store reports they receive without submitting them to the agency for the duration. The standard deadline is to submit a report to the agency within 15 days of its receipt.
Prepared in advance
Rick Kingston, president of regulatory and scientific affairs for Safety Call International, said his firm has been preparing for this eventuality for some time. Safety Call manages adverse event reporting for a variety of companies including dietary supplement firms and pharmaceutical manufacturers among other things.
“In our practice we had planned for this kind of even more than two years ago,” said Kingston, who is also a professor in the School of Pharmacy at the University of Minnesota.
“We had designed all of our systems to be operated remotely, including our call center,” Kingston told NutraIngredients-USA.
Requirement has not gone away
Kingston said there have been some misconceptions about FDA’s move. Collecting adverse event information is still required.
“This means that if companies are having trouble staffing their regulatory department due to pandemic conditions, adverse event reports may be stored and submitted as soon as operations return to pre-pandemic levels. The important thing to remember here is that the reporting requirements have not been removed, rather they have just been adjusted for those that will need extra time,” he said.
Kingston said adverse event report might be assuming even greater importance during the present crisis. Some consumers seem to be getting desperate to find some prophylactic measure that will protect them in the case of an infection. Kingston cited as an example the tragic case of a couple of consumers, apparently acting on President Trump’s statements about the potential benefit of antimalarial drugs, who ingested a product mean to clean aquariums that contained a form of chloroquinine, the active ingredient in those drugs. The man died and his wife is in critical condition.
“One important thing the FDA stated in their guidance is that manufacturers should maintain the highest feasible level of adverse event monitoring and reporting throughout the pandemic period. This is especially important in a time when people might attempt to use all types of consumer products in a manner not intended thinking that they might be able prevent or treat Covid-19 infection,” he said.
In addition to the updated guidance on adverse event reporting, FDA has also posted a document that collates Covid-19 resources. It includes details about how to maintain social distancing in a manufacturing environment and the use of non alcohol hand sanitizers. The resource also reiterates FDA’s relaxation of some requirements for on site audits under the Food Safety Modernization Act (FSMA).
