National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
September 8, 2009 • Volume 6 / Number 17

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FDA Update

New FDA Center and Advisory Committee Launch Regulation of Tobacco Products

Dr. Lawrence Deyton Dr. Lawrence Deyton

The historic Family Smoking Prevention and Tobacco Control Act was signed into law June 22 and gave the FDA authority to regulate tobacco products. On August 19, the FDA established the Center for Tobacco Products to oversee the law’s implementation and named Dr. Lawrence Deyton, clinical professor of medicine and health policy at George Washington University in Washington, DC, the center’s first director. The center and its regulatory activities will be funded by fees levied on manufacturers and importers of tobacco products.

Dr. Deyton said he is eager for the challenge to lead the tobacco products team at the FDA and “make progress in combating tobacco use—the leading cause of preventable death in the United States.” He previously served in leadership positions at the National Institute of Allergy and Infectious Diseases at NIH for 11 years.

Another activity mandated by the tobacco control bill began on August 25, with the creation of the Tobacco Products Scientific Advisory Committee; the chair will be appointed by FDA Commissioner Dr. Margaret A. Hamburg, and nominations are open for the other eight voting members, as well as three non-voting members from the tobacco industry.

Agency Issues New Rules for Obtaining Investigational Drugs

On August 12, the FDA published two new rules to clarify how seriously ill patients can access investigational drugs outside of the clinical trials system, once all standard treatment options have been exhausted. Since clinical trials have strict entry criteria, not all interested patients qualify to participate.

The first new rule expands access to investigational drugs for individual patients, intermediate-sized patient groups, and larger patient populations under a treatment protocol or an investigational new drug application (IND). Both patients’ physicians and the companies developing the investigational drugs will still need to work with the FDA to authorize any use outside of a clinical trial.

The second new rule clarifies how a company may charge patients for an investigational drug, both on and off clinical trials. The new rules do not guarantee that a manufacturer will be willing or able to provide access to a drug outside of a clinical trial.

The FDA defines investigational drugs as “new drugs that have not yet been approved by the FDA or approved drugs that have not yet been approved for a new use, and are in the process of being tested for safety and effectiveness.”

“For patients seeking expanded access to investigational drugs and biologics, the new rules make the process easier to understand,” said FDA Commissioner Dr. Margaret Hamburg in a press announcement.

The new rules will go into effect 60 days after their publication in the Federal Register.