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FDA Public Meeting on Pharmacokinetics and Antiviral Response, July 25 near Washington, D.C.

June 23, 2000

At this one-day meeting of its Antiviral Drugs Advisory Committee, the FDA will seek expert advice on using data relevant to actual drug levels in the body in its future drug approvals. We are interested for two reasons. First, pharmaceutical companies have often neglected obvious, rapid, and inexpensive testing that would help physicians use approved drugs more effectively. Second (although it is not a focus of this meeting), therapeutic drug monitoring -- dose adjustment based on blood levels actually achieved -- is clearly possible and may become important in HIV treatment in the future. (For example, we suspect that side effects are often more common in women because doses are set to the maximum tolerated (usually by men), and not adjusted for body weight. Adjustment based on blood levels -- reflecting drug absorption and metabolism, as well as body weight -- might work even better than using weight alone. In other medical fields some drugs are dosed by blood level; however, this strategy has not always proved useful.)

FDA Meeting Notice

The Food and Drug Administration (FDA) is holding a meeting of the Antiviral Drugs Advisory Committee, July 25, 2000, 8:30 a.m. to 5 p.m. at the Holiday Inn, The Ballrooms, Two Montgomery Village Avenue, Gaithersburg, MD. (You can contact the hotel directly for directions or to arrange accommodations at 301-948-8900.)

Topic: The committee will discuss current scientific data characterizing relationships between pharmacokinetic parameters (the absorption, distribution, metabolism and excretion of drugs) and virologic response to approved antiretroviral drugs used in the treatment of HIV infection. The primary objectives for the committee deliberations are to explore the usefulness of pharmacokinetic data to improve the evaluation of new drug formulations, alternative dosing regimens, and choice of dosing to optimize combination therapy with approved antiretroviral drugs. Other issues to be discussed include the relationship between pharmacokinetic parameters and drug toxicity, and safety requirements and pediatric considerations for alternative dosing regimens.

This is a policy-centered discussion, and no specific product is being considered for marketing approval at this meeting. The function of the advisory committee is to provide advice and recommendations to the agency on FDA's regulatory issues.

The meeting is open to the public, and an open public session for oral comment is scheduled from 1 p.m. to 2 p.m.

If you would like to make an oral presentation during the open public hearing, please notify the contact person (below) before July 11, 2000. Please provide a brief statement that includes the general nature of the evidence or arguments you wish to present, the name and address of your organizational affiliation (if applicable), and an indication of the approximate time requested for your presentation. Time allotted for each presentation may be limited, depending on the number of requests.

Written comments may also be submitted to the contact person by July 11, 2000.

Contact Person: Nancy Chamberlin, or Beverly O'Neil, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093), Rockville, MD, 20857, 301-827-7001, or by e-mail: CHAMBERLINN@CDER.FDA.GOV. Please call the FDA Advisory Committee Information Line, 1- 800-741-8138 (301-443-0572 in the Washington, D.C., area), code 12531, for up-to-date information on this meeting.

ISSN # 1052-4207

Copyright 2000 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.

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