- The Food and Drug Administration plans to more quickly notify the public when a food or medical product has been withdrawn from market, issuing draft guidance to industry and announcing changes to its process for reporting recalls.
- "FDA has decided that the public would benefit by having recall information about FDA-regulated products as soon as possible, even though further evaluation remains to be done," wrote Douglas Stern, who directs the agency's Office of Enforcement and Import Operations, in a Jan. 18 blog post.
- An annual review of enforcement actions shows the FDA recalled more than 9,000 products in fiscal year 2017 across all of its primary offices. Food products were the most frequently recalled, but the regulator also pulled nearly 2,000 drugs and biologics from public sale.
Under Commissioner Scott Gottlieb, the FDA has more frequently communicated new policy objectives, as well as its efforts to improve transparency and enforcement. Gottlieb's recent announcements on changes to the FDA's recall processes follow in this vein.
On Thursday, the regulator published draft guidance that details when a company should issue a public warning, as well as the information that should be included. As part of that guidance, the FDA also outlined its plans to more quickly publish information about recalls.
Currently, food and drug recalls are made public through a weekly online enforcement report. Recalls are only included in the report, however, after the FDA has made a classification of the risk a recalled product poses to the public.
One hang-up in that approach is the time required to appropriately categorize those risks.
"Recall classifications can sometimes take weeks — or even months when FDA needs to conduct a complex evaluation," Stern wrote.
In an effort to speed the process, the FDA will now post "not-yet-classified" recall notices in its enforcement report, conveying information about potentially harmful products to the public sooner.
While recalls may not always get the headlines, the FDA is quite active in flagging risky products. In financial year 2017, the agency recalled 9,199 products — up from the 8,305 the prior year, but in line with recent trends. Of those 9,000-odd recalls, nearly 1,500 were characterized as Class I recalls, meaning the FDA believed there to be a "reasonable probability" that use of the products would cause serious adverse health consequences or death.
Most recalls involved food, but 1,176 of the pulled products were drugs regulated by the FDA's Center for Drug Evaluation and Research.