The Senate Health, Education, Labor and Pensions Committee on Wednesday approved the Medical Countermeasure Innovation Act, S. 2055, which aims to improve the nation’s preparedness to counter biological threats, including smallpox and anthrax, as well as such naturally emerging disease threats as Zika and Ebola.
Introduced by Senators (Richard) Burr (R-NC) and (Bob) Casey (D-PA), the bipartisan legislation would accelerate the pace of medical countermeasures, including vaccines and medicines, for public health emergencies. Essentially, if a company develops a drug and it’s approved, they get a voucher they can keep or sell that will speed up the review of another drug.
“Today we marked up seven more bills incorporating about 15 more bipartisan proposals and that—with the seven bipartisan bills passed last month—gives a substantial start to our innovation companion to the 21st Century legislation passed by the House of Representatives,” said Sen. Lamar Alexander (R-Tenn.). “This committee produced an education bill that I considered to be the most important piece of legislation last year, and I think we can produce the most important bill of the Congress this year because our work on this bill will affect virtually every American.”
The Alliance for Biosecurity—a coalition of biopharmaceutical companies and laboratory/academic partners that promotes a strong public-private partnership to ensure medical countermeasures are available to protect public health and enhance national health security—applauded the senators for introducing reforms to reduce the nation’s vulnerability to biothreats.
The senators were presented with the Alliance’s inaugural Congressional Biosecurity Champion Award for their work last year.
“This legislation includes a number of common sense provisions that could speed up the development of the vaccines and therapeutics to address the many threats identified by the government to protect the public here at home and our military abroad,” said Co-Chair of the Alliance for Biosecurity and Senior Vice President of Global Government Affairs at Emergent BioSolutions Chris Frech. “The bill’s new private sector incentives and streamlined contracting process can help us to stay ahead of the curve when the next biological threat arrives – whether naturally occurring or man-made.”
The new legislation was also applauded by the Biotechnology Innovation Organization (BIO), a trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.
“BIO was very encouraged that the Committee passed the Medical Countermeasures Innovation Act of 2015, addressing a number of contracting and regulatory challenges and incentivizing further research and development of critical medical countermeasures products,” said BIO President and CEO Jim Greenwood. “BIO and our members have been engaged throughout this bipartisan process, and we look forward to working with members of the Committee on common sense reforms that will improve the entire ecosystem of innovation which patients rely upon to deliver new treatments.”
The reforms outlined in S. 2055 have been endorsed by the bipartisan Blue Ribbon Study Panel on Biodefense, co-chaired by former Sen. Joe Lieberman and former governor and Homeland Security Secretary Tom Ridge, which has repeatedly called for policy changes strengthening America’s ability to confront biological threats, both naturally occurring and man-made, through the development of medical countermeasures.
The recent emergence of the Zika Virus, as well as globe’s late response to the Ebola Outbreak—the deadliest in history—has called into question the nation’s preparedness to face emerging biological threats.
The Ebola outbreak in particular demonstrated the critical need to invest in the advanced research, development, and stockpiling of vaccines, drugs, and other medicines to protect the American public from biological threats and assist the international community.
In October 2014, the House of Representatives Committee on Energy and Commerce, Subcommittee on Oversight and Investigations held a hearing on the United States’ response to the Ebola outbreak. Paul Chaplin, President & CEO of Bavarian Nordic and Alliance for Biosecurity Co-Chair commended the Subcommittee for holding the hearing, nothing that no safe, effective vaccine or therapeutic currently existed to prevent or treat Ebola.
Chaplin said, “Having available medical products would likely have been a ‘game changer’ for the current outbreak” and “This situation demonstrates the critical need to invest in the advanced research, development, and stockpiling of vaccines, drugs, and other medicines to protect the American public from biological threats and assist the international community.”
With the importance of medical countermeasures in preparing for and responding to biological threats, it is imperative that incentives are put in place to attract private investment in product development. The Committee believes the Medical Countermeasure Innovation Act of 2015 will provide an important new incentive for companies to develop medical countermeasures to address current and emerging threats.
Developing these countermeasures now—before another public health crisis strikes—will be imperative to improving the nation’s preparedness efforts.
