FDA Announces Enforcement Priorities

Oct 06, 2011   

On September 19, 2011, the U.S. Food and Drug Administration (FDA) published its Guidance document entitled “Marketed Unapproved Drugs “ Compliance Policy Guide.” Found here, the document details the widespread availability of unapproved drugs on the market and explains the Agencys priorities with respect to enforcement. Because of the large volume of these drugs on the market and the FDAs limited resources, the Agency is forced to prioritize how it will exercise its enforcement discretion. Setting forth its highest priorities, the FDA intends to continue targeting unapproved drugs that pose significant health risks to consumers.

However, the Agency notes that it will also focus its enforcement efforts on those companies marketing unapproved drugs that are reformulated in an effort to evade FDA enforcement. As discussed in the Guidance, the FDA will consider “the timing of the change, the addition of an ingredient without adequate scientific justification (see, for example, 21 CFR 300.50 and 330.10(a)(4)(iv)), the creation of a new combination that has not previously been marketed, and the claims made,” when deciding whether to bring an enforcement action against those marketing reformulated products. While there are often legitimate reasons for a manufacturer to reformulate its product, it remains to be seen how FDA will focus its enforcement actions on only those that are reformulated in an effort to evade FDA enforcement.

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