Desperate Times Do Not Equal Desperate Measures

Biomanufacturing, COVID-19

Amid the coronavirus disease (COVID-19) crisis, BioFabConsulting would like to highlight the importance of adhering to the regulations to maintain patient safety. The FDA's mission is to protect and promote public health by helping safe and effective products reach the market, and the regulations are in place to uphold that mission.

A public health emergency, such as the COVID-19 pandemic, drives industry to find solutions to help combat the crisis and mitigate the effects of the pandemic. The urgency for new solutions can be beneficial to push the bounds of current technology to uncover a helpful treatment. However, such urgency to deliver potentially helpful products to sick patients as quickly as possible may lead to misbranding or adulteration, and deviation from the regulations, which promote sufficient testing and data collection to support a product’s safe and effective use.

In the past weeks, the FDA has warned several companies for marketing unproven products to treat, prevent or diagnose coronavirus disease (COVID-19), leading to misbranded and/or adulterated products. If false, unproven claims are made on a product’s label, marketing material, including internet websites and advertisements, or if the label is misleading, the product is misbranded. Further, a product may be deemed adulterated if it is marketed without appropriate authorization (i.e., a marketing application). During a public health emergency, adulteration occurs if a product does not fall within the scope of the Emergency Use Authorization (EUA). In the current pandemic, if the product is not in high demand due to shortages or deemed to have a potential benefit to treat, diagnose, or prevent COVID-19, then it must be brought to market via traditional regulatory pathways.