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U.S. Department of Health and Human Services


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Statement of Steven K. Galson, M.D., M.P.H., Regarding Unapproved Prescription Drugs - June 8, 2006

Good morning. As you’ve read in Dr. Von Eschenbach’s statement, the agency has significant public health concerns about marketed unapproved prescription drugs. Unapproved prescription drugs may not meet modern standards for safety, effectiveness, quality, and labeling. Tackling this problem should be seen as integral to the comprehensive drug safety efforts we have implemented over the last year.

As I know you are aware, the agency launched a broad initiative last year to ensure that consumers and the health care community get up-to-date drug safety information, so that they can make the best possible decisions about how to use drugs. The efforts we are announcing today emphasize FDA’s commitment to providing the American public with safe and effective drugs. While the FDA drug approval system is widely recognized for bringing safe and effective new drugs to the market, it is unfortunate that many older or existing drug products continue to be marketed in this country without required FDA approval. While this may come as a surprise to many, particularly in a year in which FDA celebrates 100 years of protecting the public health, we consider it a significant and serious drug safety issue that must be addressed since these products may pose risks to consumers.

The presence of unapproved prescription drugs on the U.S. market is in stark contrast to our current approach to drug safety. First, healthcare providers and consumers may not be able to recognize these products as lacking required FDA approval. These products may be included in widely used pharmaceutical reference materials such as the Physicians’ Desk Reference or advertised in medical journals. This means that healthcare providers cannot assume that drugs they may prescribe have been found by FDA to be safe and effective. They cannot assume that the product labeling has undergone scrutiny to ensure the appropriateness of its indications and directions for use, and they cannot rest assured that claims that a product is safe for use in children or other especially vulnerable populations are supported by sound scientific evidence. There may also be a lack of assurance that the product formulation and manufacturing practice standards will produce a safe and effective product. The product may be substandard, and it may not have the required identity, strength, and purity.

The Marketed Unapproved Drugs compliance policy guide, issued today, is a significant step forward. It outlines a prioritized, risk-based enforcement approach encouraging companies currently manufacturing drugs without required FDA approval to comply with the drug approval process and ensure the safety and efficacy of their marketed products. This guidance clearly articulates FDA’s expectation that manufacturers of products requiring FDA approval submit applications to FDA to show that their products are safe and effective. At the same time, the guidance discusses the approach the agency will use to efficiently and rationally bring such drugs into the approval process. The highest priorities for enforcement action will continue to include drugs with potential safety risks, drugs that lack evidence of effectiveness, and health fraud drugs. FDA will proceed on a case-by-case basis with these priorities in mind, with every effort made to avoid adversely affecting public health, imposing undue burdens on consumers, or unnecessarily disrupting the drug supply.

FDA has been working on the unapproved drugs issue steadily through the years. The issuance of this CPG demonstrates our renewed emphasis on this issue. Today, we are announcing that this is a significant focus for us going forward.

Our action against unapproved carbinoxamine products illustrates why unapproved drugs are a problem. FDA has serious safety concerns about use of carbinoxamine-containing products in children under the age of 2. Yet, numerous unapproved products containing carbinoxamine are specifically labeled for use in children as young as one month of age and many of these products are actually formulated and sold as infant drops. Also, although approved versions of carbinoxamine have been found effective for various allergic symptoms, some unapproved carbinoxamine products are labeled for treatment of cough and cold symptoms, an indication for which carbinoxamine has never been found safe and effective by FDA. All of this needs to change.

At FDA, providing the American public with safe and effective medical products is our core mission. Making sure that all marketed drugs have required FDA approval is a key part of that.