The pharmaceutical and medical device industries continue to be under close scrutiny by the FDA when it comes to product safety and the reporting of adverse events. With stringent regulatory requirements that’ll make any company or patient cringe, there’s no way to hide from authorities. And, rightly so.
But, guess what? There are also adverse event reporting rules in place for manufactures of dietary supplements, such as vitamins, minerals, herbs, and other nutritional foods. While these products don’t go under a pre-market review like prescription drugs, everything on the market is required to be safe. And, if the FDA finds a problem with your product through adverse event reports or other literature, they can (and have done so) take action.
According to the FDA’s Dietary Supplement and Nonprescription Drug Consumer Protection Act, nutrition companies are required to:
- Report a serious adverse event (SAE) no later than 15 business days after the report is received
- Submit any new medical information related to a submitted SAE report within 1 year of the initial report and no later than 15 business days after the new information is received
- Maintain records related to each report of an SAE for a period of 6 years
- Permit an authorized person to have access to the records during an inspection
Health Canada outlines similar rules:
- Submit a case report for each serious adverse reaction to the natural health product that occurs inside Canada within 15 days after the day on which the licensee becomes aware of the reaction
- Annually prepare and maintain a summary report that contains a concise and critical analysis of all adverse reactions to the natural health product that have occurred inside Canada within the last 12 months
Like pharmaceutical, biotechnology, and medical device companies, manufactures of dietary supplements have various options when it comes to the tools they use for collection, reporting, and analysis of adverse events. Some companies perform these activities in spreadsheets while others prefer to utilize the same safety and pharmacovigilance systems drug and device companies use. Take Herbalife, for example. In recent years, the global nutrition company implemented Oracle’s Argus Safety to help monitor adverse events.
Yes, spreadsheets may seem inexpensive and require minimal training, however, they simply lack the functionality that’s essential for the tracking and reporting of adverse events. On the other hand, systems that are specifically built for these types of activities are much more effective reliable, and compliant with global rules and regulations.
Regardless of the solution your company uses, it’s important to have the business processes and systems in place in order to remain competitive and compliant in the marketplace.
