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FDA Issues Letter Discussing its Enforcement Policy for Unapproved Drugs

The Food and Drug Administration (FDA) provided additional details on its enforcement policy on unapproved drugs in letters issued to sixty-six manufacturers and distributors of an unapproved expectorant drug product.

In the follow-up letters, FDA also announced that it intends to publish a Federal Register (FR) notice soon to further describe its enforcement policy with respect to unapproved drugs.

For historical reasons, some drugs are available in the United States that lack required FDA approval for marketing. The manufacturers of these drugs have not submitted new drug applications and received FDA approval for the legal marketing of their drugs. The new drug approval process plays an essential role in assuring that all drugs are both safe and effective. FDA believes, based on the available evidence at this time, that none of these unapproved drugs represents an imminent safety hazard. However, manufacturers of these drugs have not provided evidence of their products' safety or effectiveness, and so FDA has an interest in taking steps to obtain the required evidence without imposing undue burdens on consumers or disruptions in the market.

In October 2002, FDA sent warning letters to sixty-six companies about their marketing of single ingredient, guaifenesin extended-release drug products, without the necessary FDA approval for marketing. The warning letters followed the agency's July 2002 approval of one such product, Adams Laboratories' Mucinex. The warning letters and the follow-up letter explain that companies are required by law to submit scientific evidence demonstrating the safety and effectiveness of marketed drug products.

Following the Mucinex approval, the agency reviewed the marketing status of all strengths of single ingredient extended-release guaifenesin. FDA determined that such products should no longer be marketed in light of the existence of an FDA approved product.

FDA concluded that the unapproved products were on the market illegally and that taking them off of the market after a reasonable grace period when the similar approved product became available would, among other things, preserve the incentives for companies to develop and submit new drug applications as required by law. The scientific evidence provided in the new drug application is essential to prove the safety and effectiveness of drug products.

With respect to the single ingredient extended release guaifenesin products, FDA's longstanding policy is that all extended release drug products must obtain FDA approval. This policy has been codified in the Code of Federal Regulations since 1959.

To minimize disruption in the marketplace, today's letter allows its recipients a limited grace period to manufacture and distribute their products. But the letter also makes it clear that those products must be off the market by the end of November 2003.

FDA intends in the proposed FR notice to further describe its enforcement policy with respect to unapproved drugs. The goal of this notice is to clarify FDA's views about unapproved drugs and emphasize that illegally marketed drugs must obtain FDA approval.

In the notice, FDA will also explain that, in certain circumstances, it may provide a limited grace period when one company obtains approval of a New Drug Application for a product that other companies are marketing without approval. The purpose of the grace period will be to avoid an undue burden on consumers and industry. Companies marketing unapproved new drugs should not, however, expect any grace period to protect them from the necessity of leaving the market for some period of time while obtaining approval.

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