Reformulation targeted in FDA unapproved drug plan
For a variety of reasons 1000s of products, based on 100s of active pharmaceutical ingredients (API), are marketed without approval from the US Food and Drug Administration (FDA). Resources to tackle the problem are limited and as such the FDA is taking a risk-based approach to enforcement.
“This approach includes efforts to identify illegally marketed drugs, prioritisation of those drugs according to potential public health concerns or other impacts on the public health, and subsequent regulatory follow-up”, writes the FDA in guidance for staff and industry.
Companies that modify a product to evade anticipated enforcement against a specific formulation are high on the FDA’s list of priorities. The FDA will consider the timing of the change, the scientific justification of new ingredients, and claims made for the new product when choosing its response.
Regulatory actions will be bundled together in cases when companies are suspected of multiple violations. For example, if current good manufacturing practice (cGMP) failings are identified the FDA will pursue this alongside the unapproved drug case to make best use of limited resources.
Other priorities for the FDA are unapproved products: with potential safety risks or with limited evidence of efficacy; that are promoted deceptively; or that present a direct challenge to the new drug approval process.
The risk-based approach only applies to drugs first introduced before the new guidance. “All unapproved drugs introduced onto the market after [September 19 2011] are subject to immediate enforcement action at any time, without prior notice”, the FDA said.
