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November 2008
Vol. 18 No. 11
Policy and Advocacy
FDA Advisory Groups Warn Against Home Stockpiling of Antivirals for Pandemic Flu

Two advisory committees to the Food and Drug Administration (FDA) have recommended against home stockpiling of antivirals in preparation for pandemic influenza following a meeting in which  IDSA and other medical societies outlined their concerns.

The committees were reviewing proposals from two drug companies--GlaxoSmithKline and Roche—to develop products called MedKits consisting of the companies’ influenza antiviral drugs and patient instructions. Each of the MedKits would contain enough medication to use for either treatment (5-day course, twice daily) or prophylaxis (10-day course, once daily). The companies developed their proposals in response to a request from the Department of Health and Human Services (HHS).

At a joint meeting of FDA’s Antiviral Drugs and Nonprescription Drugs Advisory Committees on Oct. 29, IDSA and other medical societies expressed their reservations about the proposals.  “Every policy carries potential risks and benefits,” said Luciana Borio, MD, of IDSA’s National and Global Public Health Committee. “This policy introduces an uncertain time-lag between acquisition of prescription and drug-taking, and therefore introduces uncertainties regarding the risks and benefits, making this proposal particularly difficult to evaluate. An adequate science base is needed to inform this calculation.”

To understand the benefits, Dr. Borio said, more information is needed about the correct dosing and duration for the treatment of severe influenza--an important proxy for pandemic flu. “We might only learn that information once a pandemic occurs,” she said. At that point it would be difficult to get appropriate advice to individuals who have stockpiled the treatments in advance.

Other concerns include the difficulty for patients to assess when to start a prophylactic course and the possibility of drug resistance. Dr. Borio asked the committees, “Is it wise for the government to promote family purchase of a therapeutic of uncertain benefit, which might potentially be rendered ineffective due to changing susceptibility of influenza viruses, and which carries a limited shelf-life?”

Finally, she noted, the policy wouldn’t alleviate the need for public health stockpiles.

On a related front, IDSA has continued to express concerns to HHS about home stockpiling of antibiotics for a potential anthrax attack, including the importance of evaluating home stockpiling strategies and exploring other options for rapid access.

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