Last week, FDA published a guidance titled Marketed Unapproved Drugs—Compliance Policy Guide, which describes the agency’s enforcement priorities with regard to products that lack regulatory approval or that are not marketed in accordance with the over-the-counter (OTC) drug review. The document is a revision of the June 2006 guidance of the same name.
Because FDA lacks the resources to take immediate action against all illegally marketed products, it will give higher priority to enforcement actions that involve unapproved drug products in certain categories, including drugs with potential safety risks, and drugs that lack evidence of effectiveness.
Another high-priority category for FDA is health-fraud drugs. The guidance defines health fraud as “[t]he deceptive promotion, advertisement, distribution, or sale of articles . . . that are represented as being effective to diagnose, prevent, cure, treat, or mitigate disease (or other conditions), or provide a beneficial effect on health, but which have not been scientifically proven safe and effective for such purposes.” Drugs that present a direct risk to health will be the agency’s highest priority in this product category. [Read more…]