FDA Publishes Guidance on Marketed Unapproved Drugs

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FDA has published a guidance on 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 drug review.

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.

Drugs that “present direct challenges to the new drug approval and OTC drug monograph systems” also will be of high priority. These drugs include those in the three categories mentioned previously, along with unapproved drugs that directly compete with an approved drug, and drugs marketed in violation of a final and effective OTC drug monograph.

FDA also will prioritize unapproved new drugs that also violate the Food, Drug, and Cosmetic Act in other ways. These products include unapproved new drugs that violate CGMP regulations. This policy is intended to preserve the agency’s resources by pursuing all applicable charges against a drug or a firm and avoiding duplicative actions.


Finally, the agency will prioritize drugs that are reformulated to evade an FDA enforcement action. “Companies should be aware that the agency is not inclined to exercise its enforcement discretion with regard to such products,” according to the guidance. Factors that FDA may consider in determining whether to bring enforcement action against reformulated products include, the timing of the change, the addition of an ingredient without adequate scientific justification, the creation of a new combination that has not been marketed previously, and the claims made for the new product.

The enforcement priorities and potential exercise of enforcement discretion discussed in the guidance apply only to unapproved drug products that were being commercially sold as of Sept. 19, 2011, according to the document. “All unapproved drugs introduced onto the market after that date are subject to immediate enforcement action at any time, without prior notice and without regard to the enforcement priorities,” according to the guidance.

After it identifies illegally marketed products, the agency may take any of various enforcement actions, including requesting voluntary compliance; providing notice of action in a Federal Register notice; issuing an untitled letter; issuing a Warning Letter; or initiating a seizure, injunction, or other proceeding. The guidance is intended to provide notice that “any product that is being marketed illegally is subject to FDA enforcement action at any time,” according to the document.

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