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Pandemic or Not, More Stockpiling Is Needed

May 5, 2009 – 4:59 pm

FDA is warning consumers to be wary of Internet sites and e-mails promoting unapproved H1N1 virus treatments. “Consumers who purchase products to treat the novel 2009 H1N1 virus that are not approved, cleared or authorized by the FDA for the treatment or prevention of influenza risk their health and the health of their families,” says Michael Chappell, acting FDA Associate Commissioner for Regulatory Affairs, in the agency’s announcement. “In conjunction with the Federal Trade Commission, the FDA has developed an aggressive strategy to identify, investigate, and take regulatory or criminal action against individuals or businesses that wrongfully promote purported 2009 H1N1 influenza products in an attempt to take advantage of the current flu public health emergency.”

But is FDA worried about counterfeit Tamiflu and Relenza popping up? I am. Hoarding already seems to be happening, but the drug industry as well as doctors are working to prevent it, reports a New York Times article. The unintended consequence of limiting antiviral prescriptions to influenza-stricken patients, however, could mean that healthy patients seeking backup antivirals may look elsewhere, opening up a new market for counterfeiters.

Think of the risks that counterfeit antivirals could pose. Fake products could leave patients unprotected against viruses, or minimally protected if the fakes contain some legitimate ingredients. That could lead to drug resistance. In addition, patients may even be exposed to potentially harmful ingredients.

The good news is that drug manufacturers are trying to stave off counterfeiting threats. Check out this page on Roche’s site, maker of Tamiflu. And Relenza may be harder to counterfeit, given the fact that it is delivered through an inhaler. But the Royal Pharmaceutical Society of Great Britain is still worried.

What can worry teach us? To stockpile even more than we did. Drug manufacturers have been building up supplies in the National Strategic Stockpile, but there are sure to be some lessons to be learned. Were enough supplies stockpiled? Did pharmacies and hospitals themselves stockpile enough supplies?

Building up enough supply to outweigh demand may run counter to economic bottom lines, but such steps may be needed to avoid the panic that could push patients toward counterfeits.

Daphne Allen

  1. One Response to “Pandemic or Not, More Stockpiling Is Needed”

  2. FDA reported that in October the agency ordered (and later tested) products represented online as Tamiflu.

    One product sent to FDA arrived from India unlabeled. The envelope consisted of “white tablets taped between two pieces of paper that were found to contain talc and acetaminophen” not “oseltamivir, the active ingredient of Tamiflu.”

    FDA is pushing patient education hard to get worried patients to resist online products that come from unregistered pharmacies without prescriptions.

    But with the H1N1 vaccine in short supply (I know because I have been calling our family doctors over and over), will FDA’s warnings be enough?

    By dallen on Oct 23, 2009

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