This week, pharmaceutical industry regulators and manufacturers moved quickly to address public health concerns regarding the outbreak and spread of the H1N1 virus infection (swine flu). The following is an overview of key developments.

RxResponse, a network partnership established by the Pharmaceutical Research and Manufacturers of America (PhRMA) and serves as a single-point of contact for the pharmaceutical supply system, declared it was on “Alert Status.” The announcement means that partnership members are closely monitoring developing information regarding influenza cases in the United States and will collaborate with other health agencies to ensure an efficient supply chain. “Americans need to know that the medicines they rely on will be available even in an emergency. RxResponse provided federal and state crisis managers with the critical information they need about the pharmaceutical supply chain to help communities affected by an emergency return to normal as quickly as possible,” said Billy Tauzin, president and CEO of PhRMA in a prepared statement.

While industry works to develop an effective vaccine, the US Food and Drug Administration and the Federal Trade Commission issued a public alert to the public to take caution against Internet sites and other promotions claiming to diagnose, prevent, mitigate, treat, or cure the 2009 H1N1 influenza virus. The agencies are advising the operators of these sites that they must either remove the fraudulent promotions or correct them to avoid enforcement action. FDA warns that such products have not been approved, cleared, or authorized for their reported claims. “In conjunction with the Federal Trade Commission, 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,” said Michael Chappell, acting FDA Associate Commissioner for Regulatory Affairs.

On April 30, before the congressional Subcommittee on Health and the Committee on Energy and Commerce, Joshua M. Sharfstein, MD, FDA’s principal deputy commissioner and acting commissioner presented a statement detailing the agency’s response to the outbreak. FDA approved several emergency use authorizations this week, legally permitted according to the Federal Food, Drug, and Cosmetic Act under “serious or life-threatening disease or condition.” These actions (effective for one year) made two FDA-approved drugs, GlaxoSmithKline’s (London) Relenza and Roche’s (Basel) Tamiflu, available to public health and medical personnel,  makes available the emergency use of disposable resipirators (N95 units), and makes the flu panel diagnostic test to qualified laboratories. The authorization also makes Tamiflu available for use in patients under 1 year of age.

FDA has formed a Vaccine Team to facilitate the availability of a vaccine when it becomes available, an Antiviral Team to evaluate antiviral drugs and monitor its distribution, an In Vitro Diagnostics Team to identify and evaluate diagnostics to help test for the virus, a Personal Protective Equipment Team to help make this equipment available to reduce risk of exposure to the virus, a Blood Team to ensure blood supplies and products, a Shortage Team to facilitate the availability of antivirals to the American public, and a Consumer Protection Team to help protect consumers from fraudulent and potentially dangerous medical products.

GSK says it has contacted governments around the world to ascertain demand for its Relenza antiviral. The company is raising production levels to as much as 60 million treatment packs per year at a rate of 5 million per month within the next 12 to 14 weeks. GSK has also been in discussion with the World Health Organization (WHO), the US Department of Health and Human Services, the European Centre for Disease Prevention, and the US Centers for Disease Control and Prevention regarding vaccine development. The company says it “stands ready to begin manufacture of a potential vaccine against the new influenza A (H1N1) strain virus once WHO and other public health authorities make recommendations for composition of the vaccine.”

Sanofi Pasteur (Lyon, France), the vaccine division of Sanofi-aventis, announced it also has been in discussion with world health organizations and has invested in a major expansion of it influenza vaccine production capacity. The company says it will continue to manufacturer seasonal influenza vaccine as recommended by WHO as it prepares to develop a vaccine against the new H1N1 virus.
 
Roche has responded to a request by WHO to deploy its “Rapid Response Stockpile” of its antiviral Tamiflu to countries in need. The stockpile includes the two million treatment courses held by WHO and the three million courses held by Roche. The company says it continues to maximize manufacturing of Tamiflu.

As of May 6, according to WHO, 22 countries have officially reported 1516 cases of influenza A (H1N1) infection.

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