The FDA is taking steps toward more effective enforcement in the marketing of drugs of abuse testing products. As part of this, they released a draft guidance that clarifies the agency’s thinking on laboratory and non-laboratory tests and is intended to assist companies prepare pre-market submissions and comply with FDA regulations. When the first guidance was released in 2000, DATIA aggressively lobbied against many of the included recommendations, which have been changed in the new guidance. For example, tests no longer need to bundle the cost of a confirmation test with the cost of the screening test, and the FDA recognizes that tests are most often performed by a person trained in their use. DATIA is leery, however, of the FDA’s intent with the guidance based on letters that the FDA sent to four laboratories. In the letters the FDA states “Under the Federal Food, Drug, and Cosmetic Act (the Act), an over-the-counter (OTC) test sample collection system for drugs of abuse testing is a device because it is intended for use in the diagnosis of a disease or other condition, or in the cure, mitigation, treatment, or prevention of disease (section 201(h)(2) of the Act).” DATIA is in the process of consulting with legal experts on the implications of the guidance, and will provide this information to DATIA members. View the FDA Press Release, and DATIA activity on this issue.
