Unapproved means unapproved, and the U.S. Food and Drug Administration (FDA) is making moves against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. People are simply at greater risk when they ingest these unapproved substances. There are over 500 products being challenged this week. For the full extensive, detailed list, click HERE.

Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research states:

"Removing these unapproved products from the market will reduce potential risks to consumers. There are many FDA-approved prescription products, as well as appropriately marketed over-the-counter products, available to treat cough, cold, and allergy symptoms; so, we expect little or no negative impact on consumers from the removal of these unapproved products."

A major concern is that health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs' labels do not disclose that they lack FDA approval.

This is the 17th action on a drug class as part of FDA's 2006 Unapproved Drugs Initiative, including a final guidance entitled "Marketed Unapproved Drugs Compliance Policy Guide (CPG)," outlining its enforcement policies aimed at efficiently and rationally bringing all such drugs into the approval process. The FDA uses a risk-based enforcement program in order to concentrate its resources on those products that pose the highest threat to public health and without imposing undue burdens on consumers, or unnecessarily disrupting the market.

Consumers who believe they are taking an unapproved prescription cough, cold, or allergy product should contact their health care provider to discuss alternatives.

Federal law generally requires that prescription drugs in the U.S. be shown to be both safe and effective prior to marketing. The FDA's evidence-based system of drug approval and the OTC monograph system play essential roles in ensuring that drugs are both safe and effective. For instance, during the drug approval process the applicant must demonstrate that its manufacturing processes can reliably produce drug products of expected identity, strength, quality, and purity. Furthermore, FDA's review of the applicant's labeling insures that health care professionals and patients have the information necessary to understand a drug product's risks and its safe and effective use.

The Agency has serious concerns that drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling. Physicians and other healthcare practitioners, along with consumers, cannot assume that all marketed drugs have been found by the FDA to be safe and effective. For a variety of historical reasons, some drugs, mostly older products, continue to be marketed illegally in the U.S. without required FDA approval. The manufacturers of unapproved drug products have not received FDA approval and do not conform to a monograph for making over-the-counter (OTC) drugs. The lack of evidence demonstrating that these unapproved drugs are safe and effective is a significant public health concern.

Since the Compliance Policy Guide was published, FDA has removed numerous unapproved drug products from the market. Generally, the Agency has focused its enforcement efforts on classes of unapproved drugs or firms marketing unapproved drugs.

Source: United States Food and Drug Adminstration

Sy Kraft, B.A.