By Mark Land, AAHP president
November 20, 2017
Risks associated with the therapeutic use of healthcare products are real. Manufacturers and the U.S. Food and Drug Administration (FDA) balance these risks all of the time when making marketing authorization decisions. These risks can be evaluable or unanticipated. Evaluable risks from the direct chemical, physical, or biological actions of the therapeutic agent can be measured and extrapolated to the intended patient population. This evaluation rests on the assumption that the quality attributes of the product remain constant. Unanticipated risks from problems in manufacturing are often insidious, requiring several lots of a product to be removed from the market.
Product recall is a terrifying concern for manufacturers of healthcare products. The risks to consumers, expense, and negative publicity are challenging issues when faced with a recall decision. However, with planning, the recall process can be less terrifying and more efficient and effective. The recall process is an organization-wide undertaking. Recall preparedness is diminished when the organization mistakenly believes that such preparedness is the responsibility of the quality and regulatory teams alone. This can be particularly true for homeopathic firms unpracticed in risk analysis and recall execution.
The safety record of homeopathic products may give the impression of immunization from unanticipated actions of the therapeutic agent. Quality problems, until recently, rarely forced a homeopathic product recall. Cross contamination and the appearance of super potency, among other reasons, have forced homeopathic products from the market. Manufacturers can reduce uncertainty within the recall process by being well prepared.
The decision to recall a product is made more difficult due to lack of information and the time pressure within the corporate and regulatory recall deliberation process. When faced with the risk of harm to consumers, FDA and manufacturers will rightly risk error in favor of public safety.
Recalls of nonprescription drug products are voluntary, although FDA has many mechanisms to incentivize manufacturers to recall a product. FDA regulations and guidance require that you have a recall plan that is tested and proven effective. FDA’s written regulations and guidance documents are the best place to start your recall preparedness plan. Ryan Gooley of Stericycle wrote an excellent article for AAHP on the recall process and how best to prepare.
Preparedness is critical in taking the right action when faced with a potential recall. Your goal should be to make the best decision for consumers and execute your recall plan efficiently.