Wednesday, January 12, 2011

Vol. 1, No. 1: Should Congress Create Stronger Incentives to Develop Vaccines and other Medical Countermeasures Against Pandemic Influenza and Bioterrorism?

The first issue of FDLI's Food and Drug Policy Forum, "Should Congress Create Stronger Incentives to Develop Vaccines and other Medical Countermeasures Against Pandemic Influenza and Bioterrorism?" is available free at now. Download and read this interesting article by Mike Druckman, Partner at Hogan Lovells US LLP and then join the conversation in the comments.

"In an August 2010 report analyzing our national enterprise for developing medical countermeasures (MCMs) against infectious diseases and bioterrorism, the United States Department of Health and Human Services (HHS) concluded that 'transformative changes' are needed. The report announced a series of government initiatives to effect those changes. The question is whether those proposals are sufficient to accomplish the needed transformation, or whether Congress must take more decisive actions to harness the power and innovation of private industry to accomplish this goal."

In this article, Druckman recommends that Congress should:
  • Provide statutory exclusivity to the first company that licenses a universal influenza vaccine, following the Orphan Drug Act model.
  • Create an alternate regulatory pathway for MCMs for which no private market exists and for which approval or licensure is unfeasible under certain requirements.
  • Authorize and direct the U.S. Food and Drug Administration, when assessing the risk-benefit balance of MCMs being reviewed under an alternate regulatory pathway, to consider both the public health consequences of a disease outbreak or terrorist attack, and the likelihood of such an event.

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  1. This is a stimulating article that is informative for both US and non-US audience. It would be interesting to see to what extent future initiatives in the US would be inspired or reflect the proposals set out by the author.

    It is arguable that the threats of pandemic influenza and bioterrorism are equally real and actual in both the US and Europe. Consequently, as discussed in the article, the Marketing Authorization under Exceptional Circumstances pathway established in the European Union may provide a model for implementation in the US.

    Whether or not this model is followed in the US, it would appear that both the European Medicines Agency (EMA) and the FDA could benefit from an exchange of experience and best practices as regards to optimal ways to reward and incentivise the development of vaccines and other medicinal products to counter pandemic influenza and bioterrorism. Previous experience suggests, however, that the successful of such communication will be dependant on the establishment of clearly defined aims ensuring that both authorities view the purpose of the exchange in the same way .

    It would be interesting to examine whether such an exchange of views could be incorporated into the current and ongoing cooperation initiatives between the European Commission and the US Department of Health and between the EMA and the FDA.

    An example of the steps previously taken towards a limited form of cooperation is the common EMA/FDA application form for orphan medicinal product designation. While applicants pursue two separate orphan designation procedures that follow independent course and may lead to different outcome, the establishment of this common application form may be seen as reflecting the intention to facilitate and encourage companies developing treatments for rare diseases to place their products both on the EU and US market.

  2. Universal influenza vaccine candidates have been the subject of recent publications and announcements. For example, in December the FDA posted a notice on its website that researchers from the FDA and the CDC have formulated a universal influenza A vaccine candidate, which showed encouraging preclinical results in mice: On Monday, Reuters reported that researchers from the University of Chicago and the Emory University School of Medicine isolated antibodies from nine people who had been infected in the first wave of the H1N1 swine flu pandemic, and have seen early promise that those antibodies may be cross-protective against multiple influenza strains: These reports suggest that the idea of a universal flu vaccine is not unrealistic, and Congress should seriously consider ways to help accelerate the translation of that research into actual universal influenza vaccines to protect the public.


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