After countless Congressional hearings, press conferences and a blizzard of editorials and government statements the United States and the world are now left with a certainty – we are not prepared for events like this.
Knowing that the best way to combat a biological threat is with a successful vaccine or therapeutic, the Department of Health and Human Services (HHS) and the Pentagon did their best to utilize existing biodefense programs to develop Ebola countermeasures. Congress reacted by passing emergency funding to speed the process.
But these actions all came too late, after a deadly epidemic had already reached our shores. The challenge Congress now faces is ensuring we are prepared before this happens again.
For many years, Congress has funded Project BioShield to protect the American people against biologic attacks. Because the government is the only market for these products, the Biomedical Advanced Research and Development Authority (BARDA) began partnering with industry in 2006 to develop medical countermeasures (MCMs) against threats identified by the Department of Homeland Security (DHS).
This successful program included a 10-year appropriation of $5.6 billion to purchase MCMs. Understanding that the best way to be prepared is to have a robust stockpile of quickly deployable drugs and vaccines, the federal government has now stockpiled millions of doses of these MCMs in the Strategic National Stockpile (SNS). However, there remain significant gaps where no MCMs have been developed to address DHS identified threats.
The dollars associated with Project Bioshield expired in 2013. As a result, the market created to incentivize private sector MCM development has effectively vanished, as Congress now funds the program unpredictably on an annual basis. Without a predictable market for MCM products, or a sharing of risk between industry and the government, it is becoming at best challenging for any company to justify the opportunity costs associated with development of these programs to their respective shareholders and stakeholders. The entire U.S. biodefense enterprise has suffered as a result.
Congress needs to create new incentives to encourage companies to participate in the biodefense industry. Recently, in a bipartisan effort, Congress authorized the FDA to award Priority Review Vouchers (PRVs) in 16 neglected tropical disease areas, with Ebola being added in 2014. This program has been successful. Numerous companies are now participating in tropical disease research, and three vouchers having been awarded for products receiving FDA approval. A similar program in rare pediatric diseases has been created, and the FDA has provided an additional three vouchers for products receiving licensure.
A Priority Review Voucher program for national security MCMs could revive and reinvigorate the U.S. biodefense industry. By providing PRVs for the 13 pathogens identified on the DHS threat list, Congress would incentivize the private sector to use cutting-edge technologies to develop new drugs and vaccines against chemical, biological, radiological, and nuclear threats.
Priority Review Vouchers would be a powerful incentive to any company considering the development of a biodefense product. A PRV would shorten FDA’s review of a new product from 10 months to 6 months and could also be sold, thereby providing an additional incentive to the MCM developer. To avoid conflicts, MCMs with existing commercial markets, and already FDA-approved agents, would not be eligible for the biodefense PRV program. Companies would be required to pay an additional user fee to use the voucher (currently $2.5 million), so the cost of any additional resources the FDA would need under the PRV would be covered. In an unusual and unique fashion, this program would be at no cost to the FDA nor to taxpayers.
We have already been reminded the ramifications of not having solutions to biodefense threats with the global Ebola epidemic. And, according to the Director of National Intelligence, biological and chemical materials and technologies are more accessible than ever to groups like al Qaeda and ISIS. The creation of a PRV for biodefense would be a win for the government by incentivizing more development of MCMs; for industry by creating a return-on-investment in a government-only market; and most importantly for the American people by ensuring the stockpiling of new protections against biologic national security threats.
We have now reached a tipping point: the United States will either be ready for the next Ebola or the impact on our country will be worse. Congress should promptly act to create a PRV program for biodefense. We cannot afford to be ill-prepared once again when the consequences are so dire.
Dr. Bert Liang is the founding and current CEO of Pfenex Inc., a biologics company focused on the development of biodefense products and providing access to biosimilars. Dr. Liang acts as the Chair of the Biodefense Policy Advisory Committee of BIO, and is a representative on the Biosimilars Council of the Generic Pharmaceutical Organization.