By Mark Land, AAHP President
July 1, 2018
Product recalls are an important tool for manufacturers and the Food and Drug Administration (FDA) to minimize exposure to potentially harmful or ineffective products. Drug product recalls are voluntary — that is to say FDA does not have legal authority to recall a drug product. They do however have many tools at their disposal to encourage recall and discourage use of drug products.
Health care product recalls have dropped on average by 12 percent since 2014 and by 28 percent from the peak in 2012.1 The foregoing is even more impressive when the growth of business over that time is taken into consideration. Significant percentage declines are noticed in both the drug and biologics centers. Recalls on devices however have increased significantly beginning in 2011 (Table 1).
Recalls are classified based on risks to consumers. There are three classifications for health care product recalls. FDA uses the definitions below when classifying recalls.2
Recall classification means the numerical designation, i.e., I, II, or III, assigned by FDA to a particular product recall. This indicates the relative degree of health hazard presented by the product being recalled.
- Class I: Use of, or exposure to, a violative product will most likely cause serious adverse health consequences or death.
- Class II: Use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class III: Use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Nearly two thirds of recalls are Class II. Over time Class II recalls have declined consistently with the overall decline in recalls. Classes I and III recalls have been remarkably stable in number and percentage since 2015 (Table 2).
Recalls of homeopathic products have been relatively rare over the past 10 years5 (Table 3).
Recent high profile cases involving children’s products are well known. These cases and subsequent recalls in 2018 have demonstrated that FDA has a low threshold of tolerance for risk regarding homeopathic products. FDA has taken the position that homeopathic products are not proven safe and effective.3 If the numerator is zero in the benefit risk equation, any risk is unacceptable. Therefore FDA will likely always encourage a recall involving a homeopathic product presenting a health risk to consumers.
Recalls are expensive. Every recall is different, so the financial impact varies greatly. It’s based on a number of factors, including the number of units affected and the global reach of the recall.4 There are also indirect costs that need to be factored in. Direct cost of recall for a widely distributed product often approach $1 million or more.6 Indirect costs assuming minimal loss of distribution are equally high.
Our goal is to promote health among consumers of our products. Proper investment in GMP controls and sound preparation for a recall are our best chance to minimize risk to our consumers and to our businesses.
AAHP is sponsoring a webinar on recall basics this month on July 25, 2018. Leading experts in recall management will present basic concepts in this area. Take advantage of this webinar to sharpen your preparedness and become acquainted with experts in the field.
- United States Food and Drug Administration Enforcement Statistics Summaries 2008–2017, https://www.fda.gov/downloads/iceci/enforcementactions/ucm592790.pdf.
- United States Food and Drug Administration Enforcement Policy General 21 CFR 211§7.3 Definitions, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=7.3&SearchTerm=recall.
- United States Food and Drug Administration A New Era for Homeopathic Drug Product Regulation. March 22, 2018, https://www.fda.gov/drugs/developmentapprovalprocess/smallbusinessassistance/ucm601866.htm.
- Stericycle Expert Solutions Quarterly Recall Index Second Quarter 2016, http://www.stericycleexpertsolutions.com/wp-content/uploads/2016/08/STCExpertSOLUTIONS-RecallIndex-US-Q22016-FINAL.pdf.
- United States Food and Drug Administration Recall Datasets, https://www.fda.gov/aboutfda/transparency/opengovernment/ucm225433.htm.
- Author’s calculation of recall costs for an OTC product in wide distribution within the United States.