Developing drugs for rapid response to treat emerging infectious diseases requires overcoming numerous hurdles.
For a start, there are few large-scale pharmaceutical campaigns. The reality is quite the opposite, as it can be a challenge for the government to convince pharmaceutical companies to develop drugs for the U.S. national stockpile that are not also commercially viable.
“It’s difficult for us to defend [this research and production] to shareholders,” said Henrik Birk, chief operating officer of Bavarian Nordic. “More companies are leaving biodefense than entering it.”
This was a financial concern Birk told a panel of legislators and experts on Wednesday afternoon during the second session of the day-long Blue Ribbon Study Panel on Biodefense, “The Cost of Resilience: Impact of Large-Scale Biological Events on Business, Finance, and the Economy.”
Bavarian Nordic partnered with the U.S. Biomedical Advanced Research and Development Authority to stockpile Imvamune, a smallpox vaccine to protect 66 million Americans, many of whom have weakened immune systems and do not respond well to drugs for the treatment of smallpox currently in the stockpile. The ability to develop vaccines such as Imvamune is dependent on the guarantees of multi-year funding from the U.S. government to pharmaceutical companies. These companies do not currently have these assurances because much of this federal research funding is allocated on an annual basis, dissuading companies from taking risks in drug development, Birk said.
“For a company like Bavarian Nordic, [vaccine development] would have been impossible without this long-term commitment,” he said, adding that it takes about a $1 billion to develop a drug to approval.
Tom Ridge, co-chair of the panel and the first secretary of the U.S. Department of Homeland Security, echoed those sentiments.
“When we ask the private sector to take on research and development efforts like vaccines…it’s part of building a resilient country,” Ridge said.
Beyond financial concerns, the panelists and experts highlighted issues surrounding public-private sector communication during national emergencies.
Former Senate Majority Leader Tom Daschle, and member of the panel, asked the experts to “drill down on the whole notion of a public-private partnership,” seeking clarification on how the private entities they represent navigate the seemingly endless number of contacts with governments and companies around the world during an emergency.
Sara Roszak, senior director of research programs of the National Association of Chain Drug Stores, gave the example of the H1N1 outbreak of 2009-2010. When the outbreak occurred, she said her organization was able to pull together a network of pharmacies to initiate a nationwide vaccination campaign “on a drop of a dime” primarily because there were existing relationships within this pharmacy system.
Yet, strong relationships may not usurp state legislation. Some states have different emergency pharmacy laws, which complicate things during a disaster, Roszak said, who added she wasn’t sure of what efforts exist to streamline these laws across state lines.
In a final point, George Poste, accomplished scientist and ex officio of the panel, questioned whether the United States was prepared to provide enough generic medications during a national emergency when 85 percent of these drugs are manufactured overseas.